xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT05997641</url>
    </required_header>
    <id_info>
      <org_study_id>DF-003-1001</org_study_id>
      <nct_id>NCT05997641</nct_id>
    </id_info>
    <brief_title>Evaluating the Safety, Tolerability, and Pharmacokinetics of DF-003 in Healthy Subjects</brief_title>
    <official_title>A Double-Blind, Randomized, Placebo-Controlled, First-in-Human Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Orally Administered DF-003 Following Single (Part 1) and Multiple (Part 2) Ascending Doses in Healthy Subjects</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Shanghai Yao Yuan Biotechnology Ltd. (also known as Drug Farm)</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Shanghai Yao Yuan Biotechnology Ltd. (also known as Drug Farm)</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The goal of this clinical trial is to evaluate the safety, tolerability, and pharmacokinetics&#xD;
        (PK; drug metabolism) of DF-003 after oral administration of single and multiple ascending&#xD;
        doses in healthy subjects. The choice of using healthy subjects is standard in establishing&#xD;
        the preliminary safety and PK profile of a drug.&#xD;
  &#xD;
        DF-003 is a potent small molecule inhibitor of alpha-kinase 1 (ALPK1), which plays an&#xD;
        important role in immunity and inflammation. DF-003 can inhibit the immune inflammatory&#xD;
        response and has been shown to reduce renal fibrosis in preclinical models. Thus, this study&#xD;
        aims to determine the role of DF-003 in the treatment of chronic kidney disease.&#xD;
  &#xD;
        This study will include 2 parts. Part 1 is a single ascending dose (SAD) phase with an&#xD;
        optional food effect (FE) assessment, while Part 2 is a multiple ascending dose (MAD) phase.&#xD;
        Part 1 - SAD Phase with optional FE assessment will include approximately 64 subjects (up to&#xD;
        8 cohorts of 8 subjects each) and Part 2 - MAD Phase will include approximately 32 subjects&#xD;
        (up to 4 cohorts of 8 subjects each). Therefore, up to 96 subjects will be included in the&#xD;
        study.&#xD;
  &#xD;
        Study participants will be screened approximately 42 days within the first scheduled&#xD;
        administration of study medication. Screening data will be reviewed to determine subject&#xD;
        eligibility. In Part 1, subjects will be randomly assigned to receive a single oral dose of&#xD;
        DF-003 (3 x 1 milligram capsules) or matching placebo. The doses to be evaluated in Part 2&#xD;
        will be determined based on review of the available safety and PK data from Part 1.&#xD;
  &#xD;
        Subjects will be monitored for adverse events (AEs) and data will be collected for physical&#xD;
        examination, eye examination, vital signs, 12-lead electrocardiogram (ECG), Holter&#xD;
        monitoring, and clinical laboratory findings at various timepoints throughout the study.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Anticipated">September 15, 2023</start_date>
    <completion_date type="Anticipated">January 2025</completion_date>
    <primary_completion_date type="Anticipated">January 2024</primary_completion_date>
    <phase>Phase 1</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Sequential Assignment</intervention_model>
      <intervention_model_description>The study will include 2 parts: 1) Single ascending dose phase with optional food effect (FE) assessment, and 2) multiple ascending dose phase.</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Double (Participant, Investigator)</masking>
      <masking_description>Each enrolled participant will be assigned a randomization code generated with a computer program. Once generated, the randomization code will be final and will not be modified.&#xD;
  The randomization code will not be available to the personnel of the bioanalytical facility until the bioanalytical phase of the study has been completed. The treatment assignment will not be known by the study participants. Furthermore, the randomization code will not be available to the physician and clinical staff involved in the collection, monitoring, revision, or evaluation of adverse events, as well as clinical staff who could have an impact on the outcome of the study.&#xD;
  The preparation and/or administration of the drug products will be done by designated personnel that are not directly involved in the clinical aspects of the trial.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Incidence of Adverse Events (AEs)</measure>
      <time_frame>Up to 83 days</time_frame>
      <description>Safety and Tolerability</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Incidence of Serious Adverse Events (SAEs)</measure>
      <time_frame>Up to 83 days</time_frame>
      <description>Safety and Tolerability</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Maximum plasma concentration (Cmax) for DF-003</measure>
      <time_frame>Up to 83 days</time_frame>
      <description>Pharmacokinetics</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Time to maximum plasma concentration (tmax) for DF-003</measure>
      <time_frame>Up to 83 days</time_frame>
      <description>Pharmacokinetics</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Area under the plasma concentration-time curve from zero to the time of the last quantifiable concentration (AUC(0-t)) for DF-003</measure>
      <time_frame>Up to 83 days</time_frame>
      <description>Pharmacokinetics</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Area under the plasma concentration-time curve from zero to infinity ((AUC(0-∞)) for DF-003</measure>
      <time_frame>Up to 83 days</time_frame>
      <description>Pharmacokinetics</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Terminal half-life (t½) for DF-003</measure>
      <time_frame>Up to 83 days</time_frame>
      <description>Pharmacokinetics</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Apparent plasma clearance of drug after extravascular administration (CL/F) for DF-003</measure>
      <time_frame>Up to 83 days</time_frame>
      <description>Pharmacokinetics</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Apparent volume of distribution after extravascular administration (Vz/F) for DF-003</measure>
      <time_frame>Up to 83 days</time_frame>
      <description>Pharmacokinetics</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Maximum plasma concentration at steady state (Cmax,ss) for DF-003</measure>
      <time_frame>Up to 83 days</time_frame>
      <description>Pharmacokinetics</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Time to steady state Cmax (Tss,max) for DF-003</measure>
      <time_frame>Up to 83 days</time_frame>
      <description>Pharmacokinetics</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Concentration at time t (Ct) for DF-003</measure>
      <time_frame>Up to 83 days</time_frame>
      <description>Pharmacokinetics</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Concentration immediately before next dose (Ctrough) for DF-003</measure>
      <time_frame>Up to 83 days</time_frame>
      <description>Pharmacokinetics</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Apparent plasma clearance of drug after extravascular administration at steady state (CLss/F) for DF-003</measure>
      <time_frame>Up to 83 days</time_frame>
      <description>Pharmacokinetics</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Apparent volume of distribution at steady state after extravascular administration (Vz,ss/F) for DF-003</measure>
      <time_frame>Up to 83 days</time_frame>
      <description>Pharmacokinetics</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Accumulation ratio (Rac) at Cmax for DF-003</measure>
      <time_frame>Up to 83 days</time_frame>
      <description>Pharmacokinetics</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Accumulation ratio area under the concentration-time curve for DF-003</measure>
      <time_frame>Up to 83 days</time_frame>
      <description>Pharmacokinetics</description>
    </secondary_outcome>
    <number_of_arms>4</number_of_arms>
    <enrollment type="Anticipated">96</enrollment>
    <condition>Healthy</condition>
    <condition>Safety and Tolerability</condition>
    <arm_group>
      <arm_group_label>DF-003 (Single Ascending Dose, Part 1)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants will receive a single oral dose of 3 mg DF-003 (1 mg x 3).</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Placebo (Single Ascending Dose, Part 1)</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>Visually matching 0 mg DF-003 capsules.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>DF-003 (Multiple Ascending Doses, Part 2)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants will receive DF-003 once daily by oral administration for 14 days. The specific doses given will be based on data collected in Part 1 of the study. This part of the study may include 1 mg, 5 mg, or 25 mg capsules.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Placebo (Multiple Ascending Doses, Part 2)</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>Visually matching 0 mg DF-003 capsules.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>DF-003</intervention_name>
      <description>Oral administration by capsules (1 mg, 5 mg, or 25 mg).</description>
      <arm_group_label>DF-003 (Multiple Ascending Doses, Part 2)</arm_group_label>
      <arm_group_label>DF-003 (Single Ascending Dose, Part 1)</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Placebo</intervention_name>
      <description>Visually matching 0 mg DF-003 capsules.</description>
      <arm_group_label>Placebo (Multiple Ascending Doses, Part 2)</arm_group_label>
      <arm_group_label>Placebo (Single Ascending Dose, Part 1)</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Provision of signed and dated informed consent form (ICF).&#xD;
  &#xD;
            2. Ability to understand and stated willingness to comply with all study procedures and&#xD;
               availability for the duration of the study, and likeliness to complete the study as&#xD;
               planned, per the Investigator's opinion.&#xD;
  &#xD;
            3. Healthy adult male or female.&#xD;
  &#xD;
            4. If male, meets one of the following criteria:&#xD;
  &#xD;
                 1. Is able to procreate and agrees not to donate sperm from the first study drug&#xD;
                    administration to at least 90 days after the last study drug administration in&#xD;
                    addition to:&#xD;
  &#xD;
                      -  Having a female partner who is postmenopausal, surgically sterile, or&#xD;
                         otherwise incapable of becoming pregnant, OR&#xD;
  &#xD;
                      -  Having a female partner who is a woman of childbearing potential and agrees&#xD;
                         to use a highly effective method of contraception from the first study drug&#xD;
                         administration to at least 90 days after the last study drug administration,&#xD;
                         OR&#xD;
  &#xD;
                 2. Is unable to procreate; defined as surgically sterile (ie, has undergone a&#xD;
                    vasectomy at least 180 days prior to the first study drug administration).&#xD;
  &#xD;
            5. If female, meets one of the following criteria:&#xD;
  &#xD;
                 1. Physiological postmenopausal status, defined as the following:&#xD;
  &#xD;
                      -  Amenorrhea for at least 12 months prior to the first study drug&#xD;
                         administration (without an alternative medical condition); AND&#xD;
  &#xD;
                      -  Follicle stimulating hormone (FSH) levels ≥40 mIU/mL at Screening;&#xD;
  &#xD;
                      -  In the absence of 12 months of amenorrhea, 2 FSH measurements at least 3&#xD;
                         months apart and in the postmenopausal range must be documented.&#xD;
  &#xD;
                 2. Surgical postmenopausal status, defined as having had a bilateral oophorectomy or&#xD;
                    bilateral salpingo-oophorectomy with FSH levels ≥ 40 mIU/mL at Screening.&#xD;
  &#xD;
            6. Aged at least 18 years but not older than 55 years at the time of Screening.&#xD;
  &#xD;
            7. Body mass index (BMI) within 18.0 kg/m^2 to 32.0 kg/m^2, inclusively.&#xD;
  &#xD;
            8. Non- or ex-smoker (An ex-smoker is defined as someone who completed stopped using&#xD;
               nicotine products for at least 3 months prior to the first study drug administration).&#xD;
  &#xD;
            9. Have no clinically significant diseases captured in the medical history or evidence of&#xD;
               clinically significant findings on the physical examination, vital signs, eye&#xD;
               examination, and/or ECG, as determined by an Investigator.&#xD;
  &#xD;
           10. A 12-lead ECG that meets the following criteria (ECG intervals will be based on the&#xD;
               mean value of triplicate ECGs [rounded to the nearest whole number] collected at&#xD;
               Screening):&#xD;
  &#xD;
                 -  Heart rate ≥45 to ≤100 beats per minute&#xD;
  &#xD;
                 -  QT interval corrected for heart rate (QTc) according to Fridericia's formula&#xD;
                    (QTcF) ≤450 ms (males) or ≤470 ms (females)&#xD;
  &#xD;
                 -  QRS interval &lt;120 ms&#xD;
  &#xD;
                 -  PR interval ≤200 ms&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Female who is lactating.&#xD;
  &#xD;
            2. Female who is pregnant according to the pregnancy test at Screening or prior to the&#xD;
               first study drug administration&#xD;
  &#xD;
            3. Female using the following systemic contraceptives: oral, patch or vaginal ring, in&#xD;
               the 28 days prior to the first study drug administration.&#xD;
  &#xD;
            4. Female using hormone replacement therapy in the 28 days prior to the first study drug&#xD;
               administration.&#xD;
  &#xD;
            5. Female using the following systemic contraceptives: injections or implant, or&#xD;
               hormone-releasing intrauterine device in the 13 weeks prior to the first study drug&#xD;
               administration.&#xD;
  &#xD;
            6. History of significant hypersensitivity to products related to DF-003 (including&#xD;
               excipients of the formulations) as well as severe hypersensitivity reactions (like&#xD;
               angioedema) to any drugs.&#xD;
  &#xD;
            7. Presence or history of significant gastrointestinal, liver or kidney disease, or&#xD;
               surgery (with the exception of cholecystectomy and appendectomy) that may affect drug&#xD;
               bioavailability.&#xD;
  &#xD;
            8. History of significant cardiovascular, pulmonary, hematologic, neurological,&#xD;
               psychiatric, endocrine, immunologic, rheumatologic, neoplastic, metabolic, or&#xD;
               dermatologic disease.&#xD;
  &#xD;
            9. Presence of clinically significant ECG abnormalities at the Screening visit, as&#xD;
               defined by medical judgment.&#xD;
  &#xD;
           10. Use of contact lenses or eyeglasses.&#xD;
  &#xD;
           11. Presence of clinically significant visual acuity or slit-lamp biomicroscopy&#xD;
               abnormalities at the Screening visit, as defined by medical judgement.&#xD;
  &#xD;
           12. History or family history of chronic inflammatory skin disease (eg, psoriasis, atopic&#xD;
               dermatitis, drug-related rash, or chronic urticaria), or immune or autoimmune related&#xD;
               disorders, diseases, or syndromes.&#xD;
  &#xD;
           13. Major surgery (eg, requiring general anesthesia) within 12 weeks before Screening,&#xD;
               during the study, or within 12 weeks after the last dose of study drug. NOTE: Subjects&#xD;
               with planned surgical procedures to be conducted under local anesthesia may&#xD;
               participate.&#xD;
  &#xD;
           14. Presence of renal dysfunction at Screening (eg, estimated glomerular filtration rate &lt;&#xD;
               90 mL/min/1.73 m^2 calculated by the Chronic Kidney Disease Epidemiology Collaboration&#xD;
               formula).&#xD;
  &#xD;
           15. Maintenance therapy with any drug or significant history of drug dependency or alcohol&#xD;
               abuse (&gt; 3 units of alcohol per day, intake of excessive alcohol, acute or chronic).&#xD;
  &#xD;
           16. Any clinically significant illness including current acute or chronic infections in&#xD;
               the 28 days prior to the first study drug administration.&#xD;
  &#xD;
           17. Use of any prescription drugs in the 28 days prior to the first study drug&#xD;
               administration, that in the opinion of an Investigator would put into question the&#xD;
               status of the participant as healthy.&#xD;
  &#xD;
           18. Use of St. John's wort in the 28 days prior to the first study drug administration.&#xD;
  &#xD;
           19. Use of any over-the-counter medications 7 days prior to the first study drug&#xD;
               administration. Subjects will be reminded that over-the-counter medications include&#xD;
               cold preparations, aspirin, vitamins and natural products used for therapeutic&#xD;
               benefits, and antacid preparations.&#xD;
  &#xD;
           20. Positive test result for alcohol and/or drugs of abuse at Screening or prior to the&#xD;
               first drug administration.&#xD;
  &#xD;
           21. Positive screening results to HIV Ag/Ab combo, hepatitis B surface antigen, or&#xD;
               hepatitis C virus tests.&#xD;
  &#xD;
           22. Any other clinically significant abnormalities in laboratory test results at Screening&#xD;
               that would, in the opinion of an Investigator, increase the subject's risk of&#xD;
               participation, jeopardize complete participation in the study, or compromise&#xD;
               interpretation of study data.&#xD;
  &#xD;
           23. Intake of an IP in the 4 weeks (or 5 half-lives, whichever is longer) prior to the&#xD;
               first study drug administration.&#xD;
  &#xD;
           24. Intake of any biological products in the 12 months prior to the first study drug&#xD;
               administration.&#xD;
  &#xD;
           25. Current participation in another clinical or medical interventional research study.&#xD;
  &#xD;
           26. Employee of the Sponsor, Investigator or study site with direct involvement in the&#xD;
               proposed study or other studies under the direction of that Investigator or study&#xD;
               site, as well as family members of the employees or Investigator.&#xD;
  &#xD;
           27. Donation of plasma in the 7 days prior to the first study drug administration.&#xD;
  &#xD;
           28. Donation of 1 unit of blood to American Red Cross or equivalent organization or&#xD;
               donation of over 500 mL of blood in the 56 days prior to the first study drug&#xD;
               administration.&#xD;
  &#xD;
           29. Presence or history of eye lens opacification (cataracts) and eye lens degeneration.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>55 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Javid Ghandehari, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Interventional Pain Management Physician Anesthesiologist, Altasciences</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Jeysen Yogaratnam, MB.BCh, MRCSed, PhD, MBA</last_name>
      <phone>1-000-000-0000</phone>
      <email>jeysen.yogaratnam@drug-farm.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Altasciences Clinical Los Angeles, Inc</name>
        <address>
          <city>Cypress</city>
          <state>California</state>
          <zip>90630</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <link>
      <url>https://www.cdc.gov/kidneydisease/publications-resources/ckd-national-facts.html</url>
      <description>CenChronic Kidney Disease in the United States, 2021. Atlanta, GA: US Department of Health and Human Services, Centers for Disease Control and Prevention.</description>
    </link>
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    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 1, 2023</study_first_submitted>
    <study_first_submitted_qc>August 9, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 18, 2023</study_first_posted>
    <last_update_submitted>September 12, 2023</last_update_submitted>
    <last_update_submitted_qc>September 12, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>DF-003</keyword>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT05997641
  org study id: DF-003-1001
  nct id: NCT05997641
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: Yes
  is fda regulated device: No
  The goal of this clinical trial is to evaluate the safety, tolerability, and pharmacokinetics
        (PK; drug metabolism) of DF-003 after oral administration of single and multiple ascending
        doses in healthy subjects. The choice of using healthy subjects is standard in establishing
        the preliminary safety and PK profile of a drug.
  
        DF-003 is a potent small molecule inhibitor of alpha-kinase 1 (ALPK1), which plays an
        important role in immunity and inflammation. DF-003 can inhibit the immune inflammatory
        response and has been shown to reduce renal fibrosis in preclinical models. Thus, this study
        aims to determine the role of DF-003 in the treatment of chronic kidney disease.
  
        This study will include 2 parts. Part 1 is a single ascending dose (SAD) phase with an
        optional food effect (FE) assessment, while Part 2 is a multiple ascending dose (MAD) phase.
        Part 1 - SAD Phase with optional FE assessment will include approximately 64 subjects (up to
        8 cohorts of 8 subjects each) and Part 2 - MAD Phase will include approximately 32 subjects
        (up to 4 cohorts of 8 subjects each). Therefore, up to 96 subjects will be included in the
        study.
  
        Study participants will be screened approximately 42 days within the first scheduled
        administration of study medication. Screening data will be reviewed to determine subject
        eligibility. In Part 1, subjects will be randomly assigned to receive a single oral dose of
        DF-003 (3 x 1 milligram capsules) or matching placebo. The doses to be evaluated in Part 2
        will be determined based on review of the available safety and PK data from Part 1.
  
        Subjects will be monitored for adverse events (AEs) and data will be collected for physical
        examination, eye examination, vital signs, 12-lead electrocardiogram (ECG), Holter
        monitoring, and clinical laboratory findings at various timepoints throughout the study.
  allocation: Randomized
  intervention model: Sequential Assignment
  intervention model description: The study will include 2 parts: 1) Single ascending dose phase with optional food effect (FE) assessment, and 2) multiple ascending dose phase.
  primary purpose: Treatment
  masking: Double (Participant, Investigator)
  masking description: Each enrolled participant will be assigned a randomization code generated with a computer program. Once generated, the randomization code will be final and will not be modified.
  The randomization code will not be available to the personnel of the bioanalytical facility until the bioanalytical phase of the study has been completed. The treatment assignment will not be known by the study participants. Furthermore, the randomization code will not be available to the physician and clinical staff involved in the collection, monitoring, revision, or evaluation of adverse events, as well as clinical staff who could have an impact on the outcome of the study.
  The preparation and/or administration of the drug products will be done by designated personnel that are not directly involved in the clinical aspects of the trial.
  measure: Incidence of Adverse Events (AEs)
  time frame: Up to 83 days
  description: Safety and Tolerability
  measure: Incidence of Serious Adverse Events (SAEs)
  time frame: Up to 83 days
  description: Safety and Tolerability
  measure: Maximum plasma concentration (Cmax) for DF-003
  time frame: Up to 83 days
  description: Pharmacokinetics
  measure: Time to maximum plasma concentration (tmax) for DF-003
  time frame: Up to 83 days
  description: Pharmacokinetics
  measure: Area under the plasma concentration-time curve from zero to the time of the last quantifiable concentration (AUC(0-t)) for DF-003
  time frame: Up to 83 days
  description: Pharmacokinetics
  measure: Area under the plasma concentration-time curve from zero to infinity ((AUC(0-∞)) for DF-003
  time frame: Up to 83 days
  description: Pharmacokinetics
  measure: Terminal half-life (t½) for DF-003
  time frame: Up to 83 days
  description: Pharmacokinetics
  measure: Apparent plasma clearance of drug after extravascular administration (CL/F) for DF-003
  time frame: Up to 83 days
  description: Pharmacokinetics
  measure: Apparent volume of distribution after extravascular administration (Vz/F) for DF-003
  time frame: Up to 83 days
  description: Pharmacokinetics
  measure: Maximum plasma concentration at steady state (Cmax,ss) for DF-003
  time frame: Up to 83 days
  description: Pharmacokinetics
  measure: Time to steady state Cmax (Tss,max) for DF-003
  time frame: Up to 83 days
  description: Pharmacokinetics
  measure: Concentration at time t (Ct) for DF-003
  time frame: Up to 83 days
  description: Pharmacokinetics
  measure: Concentration immediately before next dose (Ctrough) for DF-003
  time frame: Up to 83 days
  description: Pharmacokinetics
  measure: Apparent plasma clearance of drug after extravascular administration at steady state (CLss/F) for DF-003
  time frame: Up to 83 days
  description: Pharmacokinetics
  measure: Apparent volume of distribution at steady state after extravascular administration (Vz,ss/F) for DF-003
  time frame: Up to 83 days
  description: Pharmacokinetics
  measure: Accumulation ratio (Rac) at Cmax for DF-003
  time frame: Up to 83 days
  description: Pharmacokinetics
  measure: Accumulation ratio area under the concentration-time curve for DF-003
  time frame: Up to 83 days
  description: Pharmacokinetics
  arm group label: DF-003 (Single Ascending Dose, Part 1)
  arm group type: Experimental
  description: Participants will receive a single oral dose of 3 mg DF-003 (1 mg x 3).
  arm group label: Placebo (Single Ascending Dose, Part 1)
  arm group type: Placebo Comparator
  description: Visually matching 0 mg DF-003 capsules.
  arm group label: DF-003 (Multiple Ascending Doses, Part 2)
  arm group type: Experimental
  description: Participants will receive DF-003 once daily by oral administration for 14 days. The specific doses given will be based on data collected in Part 1 of the study. This part of the study may include 1 mg, 5 mg, or 25 mg capsules.
  arm group label: Placebo (Multiple Ascending Doses, Part 2)
  arm group type: Placebo Comparator
  description: Visually matching 0 mg DF-003 capsules.
  intervention type: Drug
  intervention name: DF-003
  description: Oral administration by capsules (1 mg, 5 mg, or 25 mg).
  arm group label: DF-003 (Multiple Ascending Doses, Part 2)
  arm group label: DF-003 (Single Ascending Dose, Part 1)
  intervention type: Drug
  intervention name: Placebo
  description: Visually matching 0 mg DF-003 capsules.
  arm group label: Placebo (Multiple Ascending Doses, Part 2)
  arm group label: Placebo (Single Ascending Dose, Part 1)
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 55 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Javid Ghandehari, MD
  role: Principal Investigator
  affiliation: Interventional Pain Management Physician Anesthesiologist, Altasciences
  last name: Jeysen Yogaratnam, MB.BCh, MRCSed, PhD, MBA
  phone: 1-000-000-0000
  email: jeysen.yogaratnam@drug-farm.com
  facility: 
  status: Recruiting
  country: United States
  url: https://www.cdc.gov/kidneydisease/publications-resources/ckd-national-facts.html
  description: CenChronic Kidney Disease in the United States, 2021. Atlanta, GA: US Department of Health and Human Services, Centers for Disease Control and Prevention.
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