<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/NCT02238834</url>
  </required_header>
  <id_info>
    <org_study_id>FP02C-14-001</org_study_id>
    <nct_id>NCT02238834</nct_id>
  </id_info>
  <brief_title>Phase 1 Safety, Tolerability and Pharmacokinetics (PK) Study of FP-025 in Healthy Volunteers</brief_title>
  <official_title>A Randomized, Double-blind, Placebo Controlled, Single Ascending Dose and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of FP-025, an MMP-12 Inhibitor, in Healthy Male Subjects</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Foresee Pharmaceuticals Co., Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>QPS-Qualitix</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Foresee Pharmaceuticals Co., Ltd.</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>
      This is a randomized, placebo controlled, single and multiple ascending dose study to assess&#xD;
      the safety and tolerability and pharmacokinetics of FP-025 in healthy subjects.&#xD;
&#xD;
      Note: Dosing in the SAD phase was completed, and the planned MAD portion of the study was not&#xD;
      conducted. Evaluation of FP-025 MAD is being conducted under a separate protocol (Study No.&#xD;
      FP02C-17-001).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In the SAD part of the study the investigational drug will be administered once in a dose&#xD;
      escalation manner starting from 200 mg in Cohort 1 to 2000 mg in Cohort 6. The study drug&#xD;
      will be orally taken as capsules. In the MAD part of the study the investigational drug will&#xD;
      be administrated twice daily for 5 days depending on the half-life of FP-025, as determined&#xD;
      in the SAD part of the study. Study subjects will be randomized in a 1:3 ratio to either&#xD;
      placebo or FP-025 in every cohort of the SAD and MAD part of the study.&#xD;
&#xD;
      Note: Dosing in the SAD phase was completed, and the planned MAD portion of the study was not&#xD;
      conducted. Evaluation of FP-025 MAD is being conducted under a separate protocol (Study No.&#xD;
      FP02C-17-001).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 2015</start_date>
  <completion_date type="Actual">December 2018</completion_date>
  <primary_completion_date type="Actual">December 2018</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>Single ascending dose (SAD): Safety and tolerability of FP-025</measure>
    <time_frame>9 days</time_frame>
    <description>Safety evaluation will study the adverse event (AE) profile, clinical laboratory safety tests, vital signs, and ECG monitoring</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Multiple ascending dose (MAD): Safety and tolerability of FP-025</measure>
    <time_frame>13 days</time_frame>
    <description>Safety evaluation will study the adverse event (AE) profile, clinical laboratory safety tests, vital signs, and ECG monitoring</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Single ascending dose (SAD): Pharmacokinetics of FP-025</measure>
    <time_frame>2 days</time_frame>
    <description>Plasma concentrations of FP-025</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Multiple ascending dose (MAD): Pharmacokinetics of FP-025</measure>
    <time_frame>6 days</time_frame>
    <description>Plasma concentrations of FP-025</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Anticipated">80</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>SAD Cohorts 1-8 Experimental Arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>SAD Cohorts 1-8 Placebo Arm</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>MAD Cohorts 1 through 4 Experimental Arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Note: The planned MAD portion of the study was not conducted. Evaluation of FP-025 MAD is being conducted under a separate protocol (Study No. FP02C-17-001).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>MAD Cohorts 1 through 4 Placebo Arm</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Note: The planned MAD portion of the study was not conducted. Evaluation of FP-025 MAD is being conducted under a separate protocol (Study No. FP02C-17-001).</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>FP-025</intervention_name>
    <description>Subjects will receive single doses of 200 to up to 800 mg of FP-025 (API-in-capsule) in a dose escalation format (cohorts 1-3). Subjects will receive single doses of 50 to up to 450 mg of FP-025 (ASD-in-capsule) in a dose escalation format (cohorts 4-8).</description>
    <arm_group_label>SAD Cohorts 1-8 Experimental Arm</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Subjects will receive single doses of FP-025 matching placebo (capsule) in a dose escalation format.</description>
    <arm_group_label>SAD Cohorts 1-8 Placebo Arm</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>FP-025</intervention_name>
    <description>Subjects will receive doses of FP-025 (capsule) twice daily for 5 days.</description>
    <arm_group_label>MAD Cohorts 1 through 4 Experimental Arm</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Subjects will receive FP-025 matching placebo (capsule) twice daily for 5 days</description>
    <arm_group_label>MAD Cohorts 1 through 4 Placebo Arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Males aged ≥20 and ≤65 years with a BMI ≥18 kg/m2 and ≤30 kg/m2.&#xD;
&#xD;
          -  A resting pulse ≥50 bpm and ≤100 bpm at the Screening Visit.&#xD;
&#xD;
          -  A resting systolic blood pressure of ≤140 mmHg and a resting diastolic blood pressure&#xD;
             of ≤90 mmHg at the Screening Visit and the Safety Baseline Visit.&#xD;
&#xD;
          -  Baseline laboratory test values within reference ranges based on the blood and urine&#xD;
             samples taken at the Screening Visit. Out of normal ranges values (except for liver&#xD;
             parameters) may be accepted by the investigator, if not clinically significant.&#xD;
&#xD;
          -  The subject is, in the opinion of the investigator, generally healthy based on&#xD;
             assessment of medical history, physical examination, vital signs, electrocardiogram&#xD;
             (ECG), and the results of the haematology, clinical chemistry, urinalysis, serology,&#xD;
             and other laboratory tests.&#xD;
&#xD;
          -  Adequate contraception (double-barrier) will be applied during and until 3 months&#xD;
             after completion of the study.&#xD;
&#xD;
          -  Signed Informed Consent prior to any study related procedures.&#xD;
&#xD;
          -  Ability to communicate well with the investigator, in the local language, and to&#xD;
             understand and comply with the requirements of the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  The subject has taken prescription or non-prescription medication, herbal remedies,&#xD;
             vitamins or minerals within 2 weeks prior to the first dose of study product (or&#xD;
             within 5 half-lives prior to inclusion for any medication ingested, whichever is&#xD;
             longer).&#xD;
&#xD;
          -  The subject has a substance abuse-related disorder or has a significant history of&#xD;
             drug or alcohol abuse, or a history of drug abuse or a history of substance abuse&#xD;
             deemed significant by the investigator.&#xD;
&#xD;
          -  The subject should avoid alcohol for at least 5 days before admission into the clinic.&#xD;
&#xD;
          -  The subject has taken any investigational products within 30 days prior to the first&#xD;
             dose of study product.&#xD;
&#xD;
          -  The subject has a history of severe drug allergy or hypersensitivity or food allergy.&#xD;
&#xD;
          -  The subject has a history or presence of any clinically significant immunological,&#xD;
             cardiovascular, respiratory, metabolic, renal, hepatic, gastrointestinal,&#xD;
             endocrinological (in particular diabetes or pre-diabetes), haematological,&#xD;
             dermatological, venereal, neurological, chronic infectious or psychiatric disease or&#xD;
             other major disorder.&#xD;
&#xD;
          -  The subject has a history of cancer, other than basal cell or Stage 1 squamous cell&#xD;
             carcinoma of the skin, which has not been in remission for at least 5 years prior to&#xD;
             the first dose of study product.&#xD;
&#xD;
          -  The subject has a history of abdominal surgery (excluding laparoscopic cholecystectomy&#xD;
             or uncomplicated appendectomy) or thoracic or non-peripheral vascular surgery within 6&#xD;
             months prior to the first dose of study product.&#xD;
&#xD;
          -  The subject has any concurrent illness that may affect the particular target or&#xD;
             absorption, distribution, and elimination of the study product.&#xD;
&#xD;
          -  The subject has had a clinically significant illness within 4 weeks prior to the first&#xD;
             dose of study product.&#xD;
&#xD;
          -  The subject has had surgery or trauma with significant blood loss within the last 3&#xD;
             months prior to the first dose of study product.&#xD;
&#xD;
          -  The subject has donated blood more than 250 mL within 2 months prior to the first dose&#xD;
             of study product.&#xD;
&#xD;
          -  The subject has tested positive for human immunodeficiency virus (HIV), hepatitis B&#xD;
             surface antigen (HBsAg), or hepatitis C virus antibody (anti-HCV).&#xD;
&#xD;
          -  The subject is a current smoker or uses other nicotine containing products. Ex-smokers&#xD;
             must have ceased smoking at least 6 months prior to the first dose of study product (+&#xD;
             &lt;10 pack years).&#xD;
&#xD;
          -  The subject has tested positive at the Screening Visit and at the Safety Baseline&#xD;
             Visit for drugs of abuse (amphetamine, cannabinoid, cocaine, morphine, and&#xD;
             phencyclidine).&#xD;
&#xD;
          -  The subject's corrected QT interval (QTc) (Bazett's or Fridericia's correction) is&#xD;
             &gt;450 ms as read on the printout of the ECG produced by the ECG equipment and evaluated&#xD;
             by the investigator at the Screening Visit and at the Safety Baseline Visit. An&#xD;
             out-of-range or abnormal ECG may be repeated. In total, 3 ECGs should be recorded&#xD;
             consecutively and the investigator must evaluate the triplicate ECG. If the subject's&#xD;
             QTc is &gt;450 ms on at least 2 ECGs, the subject must be excluded.&#xD;
&#xD;
          -  The subject exercises extensively (e.g. marathon, triathlon or other similar high&#xD;
             energetic sports). In general, subjects should refrain from sporting for at least 4&#xD;
             days before participation to the study.&#xD;
&#xD;
          -  The subject is, in the opinion of the investigator, unlikely to comply with the&#xD;
             clinical study protocol or is unsuitable for any other reason.&#xD;
&#xD;
          -  A history of psychiatric diseases, i.e depression and/or anxiety related illness.&#xD;
&#xD;
          -  Serum creatinine, aspartate aminotransferase (AST) or alanine aminotransferase (ALT)&#xD;
             above the upper limit of normal (ULN) and deemed clinically significant by the&#xD;
             investigator at screening and at the Safety Baseline Visit.&#xD;
&#xD;
          -  Hemoglobin, white blood cells (WBC) or platelet count below the lower limit of normal&#xD;
             (LLN) and deemed clinically significant by the investigator at screening and at the&#xD;
             Safety Baseline Visit.&#xD;
&#xD;
          -  Other laboratory results which are clinically significant abnormal at screening and at&#xD;
             the Safety Baseline Visit.&#xD;
&#xD;
          -  Legal incapacity or limited legal capacity at screening and at the Safety Baseline&#xD;
             Visit.&#xD;
&#xD;
          -  Employees of the investigator or study centre, as well as first grade family members&#xD;
             of the employees or the investigator.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Taipei Veterans General Hospital</name>
      <address>
        <city>Taipei</city>
        <zip>11217</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <removed_countries>
    <country>United States</country>
  </removed_countries>
  <verification_date>August 2022</verification_date>
  <study_first_submitted>September 5, 2014</study_first_submitted>
  <study_first_submitted_qc>September 9, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 12, 2014</study_first_posted>
  <last_update_submitted>August 4, 2022</last_update_submitted>
  <last_update_submitted_qc>August 4, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">August 8, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Phase I</keyword>
  <keyword>Safety and tolerability</keyword>
  <keyword>Pharmacokinetic</keyword>
  <keyword>Randomized</keyword>
  <keyword>Double Blind</keyword>
  <keyword>Placebo-Controlled</keyword>
  <keyword>Single- &amp; Multiple Dose Escalation</keyword>
  <keyword>FP-025</keyword>
  <keyword>MMP-12 inhibitor</keyword>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT02238834
org study id: FP02C-14-001
nct id: NCT02238834
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
This is a randomized, placebo controlled, single and multiple ascending dose study to assess
      the safety and tolerability and pharmacokinetics of FP-025 in healthy subjects.

      Note: Dosing in the SAD phase was completed, and the planned MAD portion of the study was not
      conducted. Evaluation of FP-025 MAD is being conducted under a separate protocol (Study No.
      FP02C-17-001).
In the SAD part of the study the investigational drug will be administered once in a dose
      escalation manner starting from 200 mg in Cohort 1 to 2000 mg in Cohort 6. The study drug
      will be orally taken as capsules. In the MAD part of the study the investigational drug will
      be administrated twice daily for 5 days depending on the half-life of FP-025, as determined
      in the SAD part of the study. Study subjects will be randomized in a 1:3 ratio to either
      placebo or FP-025 in every cohort of the SAD and MAD part of the study.

      Note: Dosing in the SAD phase was completed, and the planned MAD portion of the study was not
      conducted. Evaluation of FP-025 MAD is being conducted under a separate protocol (Study No.
      FP02C-17-001).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Single ascending dose (SAD): Safety and tolerability of FP-025
time frame: 9 days
description: Safety evaluation will study the adverse event (AE) profile, clinical laboratory safety tests, vital signs, and ECG monitoring
measure: Multiple ascending dose (MAD): Safety and tolerability of FP-025
time frame: 13 days
description: Safety evaluation will study the adverse event (AE) profile, clinical laboratory safety tests, vital signs, and ECG monitoring
measure: Single ascending dose (SAD): Pharmacokinetics of FP-025
time frame: 2 days
description: Plasma concentrations of FP-025
measure: Multiple ascending dose (MAD): Pharmacokinetics of FP-025
time frame: 6 days
description: Plasma concentrations of FP-025
arm group label: SAD Cohorts 1-8 Experimental Arm
arm group type: Experimental
arm group label: SAD Cohorts 1-8 Placebo Arm
arm group type: Placebo Comparator
arm group label: MAD Cohorts 1 through 4 Experimental Arm
arm group type: Experimental
description: Note: The planned MAD portion of the study was not conducted. Evaluation of FP-025 MAD is being conducted under a separate protocol (Study No. FP02C-17-001).
arm group label: MAD Cohorts 1 through 4 Placebo Arm
arm group type: Placebo Comparator
description: Note: The planned MAD portion of the study was not conducted. Evaluation of FP-025 MAD is being conducted under a separate protocol (Study No. FP02C-17-001).
intervention type: Drug
intervention name: FP-025
description: Subjects will receive single doses of 200 to up to 800 mg of FP-025 (API-in-capsule) in a dose escalation format (cohorts 1-3). Subjects will receive single doses of 50 to up to 450 mg of FP-025 (ASD-in-capsule) in a dose escalation format (cohorts 4-8).
arm group label: SAD Cohorts 1-8 Experimental Arm
intervention type: Drug
intervention name: Placebo
description: Subjects will receive single doses of FP-025 matching placebo (capsule) in a dose escalation format.
arm group label: SAD Cohorts 1-8 Placebo Arm
intervention type: Drug
intervention name: FP-025
description: Subjects will receive doses of FP-025 (capsule) twice daily for 5 days.
arm group label: MAD Cohorts 1 through 4 Experimental Arm
intervention type: Drug
intervention name: Placebo
description: Subjects will receive FP-025 matching placebo (capsule) twice daily for 5 days
arm group label: MAD Cohorts 1 through 4 Placebo Arm
criteria: 
gender: Male
minimum age: 20 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Taiwan
country: United States
responsible party type: Sponsor