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/NCT06008652</url>
    </required_header>
    <id_info>
      <org_study_id>DR-0201-HV-001</org_study_id>
      <nct_id>NCT06008652</nct_id>
    </id_info>
    <brief_title>A Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of DR-0201 in Healthy Adult Volunteers</brief_title>
    <official_title>A First-in-Human Multiple Expansion Cohort Phase 1 Study Evaluating the Safety and Activity of DR-0201 as Single Ascending Dose in Healthy Volunteers</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Dren Bio</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Novotech</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Dren Bio</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        This is a randomized, double-blind, placebo-controlled dose escalation study to evaluate the&#xD;
        safety, tolerability, PK, PD, and immunogenicity of IV administered DR-0201 in healthy&#xD;
        volunteers.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">November 2023</start_date>
    <completion_date type="Anticipated">June 2024</completion_date>
    <primary_completion_date type="Anticipated">June 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>Parallel Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Double (Participant, Investigator)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Safety and tolerability. To determine the incidence and severity of adverse events as assessed by CTCAE v5.0 after a single IV dose</measure>
      <time_frame>Up to 57 days</time_frame>
    </primary_outcome>
    <secondary_outcome>
      <measure>PK after a single IV dose: area under the plasma concentration time curve [AUC0-t].</measure>
      <time_frame>Up to 57 days</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>PK after a single IV dose: maximum observed plasma concentration [Cmax].</measure>
      <time_frame>Up to 57 days</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>PK after a single IV dose: time of occurrence of Cmax (tmax),</measure>
      <time_frame>Up to 57 days</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>PK after a single IV dose: estimated half-life</measure>
      <time_frame>Up to 57 days</time_frame>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">48</enrollment>
    <condition>Healthy Adult Volunteers</condition>
    <arm_group>
      <arm_group_label>DR-0201</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Subjects in this arm will receive a single dose of DR-0201</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Placebo</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>Subjects in this arm will receive a single dose of placebo</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>DR-0201</intervention_name>
      <description>DR-0201 is a bi-specific antibody</description>
      <arm_group_label>DR-0201</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Placebo</intervention_name>
      <description>Placebo</description>
      <arm_group_label>Placebo</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Key Inclusion Criteria:&#xD;
  &#xD;
            1. Healthy, in the opinion of the Investigator, as determined by medical evaluation&#xD;
               including medical history, physical examination, laboratory tests, vital signs, and&#xD;
               12-lead ECGs. A subject with a clinical abnormality or laboratory parameter(s) outside&#xD;
               the reference range for the population being studied that is not specifically listed&#xD;
               in the inclusion or exclusion criteria may be included if the Investigator (in&#xD;
               consultation with the Medical Monitor) agree and document that the finding is unlikely&#xD;
               to introduce additional risk factors and will not interfere with the study procedures&#xD;
               or data interpretation.&#xD;
  &#xD;
            2. Between 18 and 55 years of age inclusive, at the time of signing the informed consent.&#xD;
  &#xD;
            3. Body weight at screening ≥ 40 kg and &lt; 120 kg, with body mass index between 18 and 30&#xD;
               kg/m2.&#xD;
  &#xD;
            4. Capable of giving signed informed consent, which includes compliance with the&#xD;
               requirements and restrictions listed in the informed consent form and in this&#xD;
               protocol, including the protocol-mandate hospitalization.&#xD;
  &#xD;
            5. Use of a highly effective contraceptive measure (&lt; 1% failure rate; see Section 13.1)&#xD;
               for all males and all females of childbearing potential during study and 90 days post&#xD;
               dose for males and 30 days post dose for females. Females of childbearing potential&#xD;
               need to have a confirmatory urine pregnancy test on Day -1. Females who are not of&#xD;
               childbearing potential (i.e., who are considered to be post-menopausal [≥ 12 months of&#xD;
               non-therapy amenorrhea] or surgically sterile [absence&#xD;
  &#xD;
          Key Exclusion Criteria:&#xD;
  &#xD;
            1. History or presence of a disease or condition that, in the Investigator's opinion,&#xD;
               constitutes a risk when taking study drug or interfering with study assessment or&#xD;
               interpretation of the data (e.g., autoimmune disease). Subjects post cholecystectomy&#xD;
               are acceptable. Subjects with resolved childhood asthma not requiring prescription&#xD;
               medicine are acceptable. Subjects with Gilbert's disease are acceptable if total&#xD;
               bilirubin ≤3× ULN.&#xD;
  &#xD;
            2. Medical history of severe allergic reaction, angioedema, anaphylaxis, clinically&#xD;
               significant drug hypersensitivity reaction, or autoimmune or immunodeficiency&#xD;
               disorder.&#xD;
  &#xD;
            3. Active infection or a history of serious infections as follows:&#xD;
  &#xD;
                 1. Use of antimicrobials (antibacterials, antivirals, antifungals, or antiparasitic&#xD;
                    agents) for an infection within 30 days before first dose. Topical treatments may&#xD;
                    be allowed at the Medical Monitor's discretion.&#xD;
  &#xD;
                 2. History of opportunistic infections in the last 2 years.&#xD;
  &#xD;
                 3. Recurrent or chronic infection, or other active infection, that in the opinion of&#xD;
                    the Investigator might cause this study to be detrimental to the subject.&#xD;
  &#xD;
                 4. Symptomatic herpes zoster within 3 months prior to screening.&#xD;
  &#xD;
                 5. History of tuberculosis (active or latent) irrespective of treatment status.&#xD;
  &#xD;
                 6. Any history of viral hepatitis: hepatitis B virus, hepatitis C virus (HCV),&#xD;
                    hepatitis E virus.&#xD;
  &#xD;
               HCV is acceptable if HCV RNA is undetectable for at least 3 months post completion of&#xD;
               direct-acting antiviral therapy.&#xD;
  &#xD;
            4. Any planned major surgical procedure during the study.&#xD;
  &#xD;
            5. History of malignant neoplasm within the last 10 years, except for fully treated&#xD;
               nonmetastatic basal or squamous cell cancers of the skin (within 3 years) that shows&#xD;
               no evidence of recurrence.&#xD;
  &#xD;
            6. Use of prescription or non-prescription drugs (including recreational drugs and herbal&#xD;
               medications) within 7 days or 5 half-lives (whichever is longer) prior to dosing,&#xD;
               unless in the opinion of the Investigator (in consultation with the Medical Monitor),&#xD;
               the medication will not interfere with the study or compromise subject safety.&#xD;
               Paracetamol (acetaminophen) at doses of ≤ 4 grams/day, and occasional use of&#xD;
               non-steroidal anti-inflammatory drugs at licensed doses, are permitted.&#xD;
  &#xD;
            7. Live or live-attenuated vaccination within 4 weeks of Day 1, or plan to receive a live&#xD;
               vaccination during the study until follow-up.&#xD;
  &#xD;
            8. Previous exposure to DR-0201, or known hypersensitivity to biologics.&#xD;
  &#xD;
            9. Prior anaphylaxis to a biological agent or vaccine.&#xD;
  &#xD;
           10. Neutrophil or lymphocyte counts below the normal range.&#xD;
  &#xD;
           11. Estimated glomerular filtration rate by Chronic Kidney Disease Epidemiology&#xD;
               Collaboration equation calculation ≤ 90 mL/min/1.73 m2 at screening.&#xD;
  &#xD;
           12. Alanine transaminase &gt; 2× upper limit of normal (ULN) and bilirubin &gt; 1.5 × ULN&#xD;
               (isolated bilirubin &gt; 1.5 × ULN is acceptable if bilirubin is fractionated and direct&#xD;
               bilirubin &lt; 35%) at screening. Bilirubin &gt; 3 × ULN if known Gilbert's disease.&#xD;
  &#xD;
           13. Other clinically significant abnormalities of laboratory assessments, as judged by the&#xD;
               Investigator and/or Medical Monitor, that could affect the safety of the subject, or&#xD;
               the interpretation of the data from the study.&#xD;
  &#xD;
           14. Positive serology for human immunodeficiency virus (HIV) at screening.&#xD;
  &#xD;
           15. Positive drug/alcohol screen at screening or baseline.&#xD;
  &#xD;
           16. QT interval corrected for heart rate (QTc) &gt; 450 msec, based on the mean of triplicate&#xD;
               ECGs. The QTc is the QT interval corrected using Fridericia's formula (QTcF; preferred&#xD;
               method), or another method, machine or overread.&#xD;
  &#xD;
           17. Seated blood pressure is less than 90/40 mmHg or greater than 140/90 mmHg at&#xD;
               screening. Heart rate is lower than 40 bpm or higher than 100 bpm at screening.&#xD;
  &#xD;
           18. Participation in a clinical trial and has received an investigational product within&#xD;
               the following time period prior to screening in the current study: 3 months (for&#xD;
               biologic therapies) or 1 month (for non-biologic therapies), 5 half-lives, or twice&#xD;
               the duration of the biological effect of the investigational product (whichever is&#xD;
               longer).&#xD;
  &#xD;
           19. Exposure to more than 4 new chemical entities within 12 months prior to the first&#xD;
               dosing day.&#xD;
  &#xD;
           20. Participation in a clinical study resulting in loss of blood or blood products in&#xD;
               excess of 500 mL within 3 months prior to enrollment.&#xD;
  &#xD;
           21. Any other medical or psychiatric condition, or laboratory abnormality that would, in&#xD;
               the opinion of the Investigator or Medical Monitor, increase the subject's risk of&#xD;
               participation, jeopardize completion of the study, or compromise interpretation of the&#xD;
               study data. Subjects receiving systemic medication for depression are not acceptable&#xD;
  &#xD;
           22. Unstable lifestyle factors (including but not limited to excessive alcohol use, heavy&#xD;
               nicotine use, or substance abuse), to the extent that in the opinion of the&#xD;
               Investigator they would interfere with the ability of a subject to complete the study.&#xD;
               Up to four units of alcohol per week are allowed once the in-patient period is&#xD;
               complete.&#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>Matthias Will, MD</last_name>
      <role>Study Director</role>
      <affiliation>Dren Bio</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Dren Central Contact</last_name>
      <phone>415-737-5277</phone>
      <email>clinops@drenbio.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Dren Investigational Site</name>
        <address>
          <city>Adelaide</city>
          <state>South Australia</state>
          <zip>5000</zip>
          <country>Australia</country>
        </address>
      </facility>
      <contact>
        <last_name>Dren Central Contact</last_name>
        <phone>415-735-5277</phone>
        <email>clinops@drenbio.com</email>
      </contact>
    </location>
    <location_countries>
      <country>Australia</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 14, 2023</study_first_submitted>
    <study_first_submitted_qc>August 18, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 23, 2023</study_first_posted>
    <last_update_submitted>August 18, 2023</last_update_submitted>
    <last_update_submitted_qc>August 18, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 23, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <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/NCT06008652
  org study id: DR-0201-HV-001
  nct id: NCT06008652
  lead sponsor: 
  collaborator: 
  is fda regulated drug: No
  is fda regulated device: No
  is us export: No
  This is a randomized, double-blind, placebo-controlled dose escalation study to evaluate the
        safety, tolerability, PK, PD, and immunogenicity of IV administered DR-0201 in healthy
        volunteers.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Double (Participant, Investigator)
  measure: Safety and tolerability. To determine the incidence and severity of adverse events as assessed by CTCAE v5.0 after a single IV dose
  time frame: Up to 57 days
  measure: PK after a single IV dose: area under the plasma concentration time curve [AUC0-t].
  time frame: Up to 57 days
  measure: PK after a single IV dose: maximum observed plasma concentration [Cmax].
  time frame: Up to 57 days
  measure: PK after a single IV dose: time of occurrence of Cmax (tmax),
  time frame: Up to 57 days
  measure: PK after a single IV dose: estimated half-life
  time frame: Up to 57 days
  arm group label: DR-0201
  arm group type: Experimental
  description: Subjects in this arm will receive a single dose of DR-0201
  arm group label: Placebo
  arm group type: Placebo Comparator
  description: Subjects in this arm will receive a single dose of placebo
  intervention type: Drug
  intervention name: DR-0201
  description: DR-0201 is a bi-specific antibody
  arm group label: DR-0201
  intervention type: Drug
  intervention name: Placebo
  description: Placebo
  arm group label: Placebo
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 55 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Matthias Will, MD
  role: Study Director
  affiliation: Dren Bio
  last name: Dren Central Contact
  phone: 415-737-5277
  email: clinops@drenbio.com
  facility: 
  contact: 
  country: Australia
  responsible party type: Sponsor
  sharing ipd: No