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Phase I Study of D-0120 to Evaluate Safety and PK/PD Study in Healthy Volunteers

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ClinicalTrials.gov Identifier: NCT04097405
Recruitment Status : Recruiting
First Posted : September 20, 2019
Last Update Posted : September 20, 2019
Sponsor:
Information provided by (Responsible Party):
InventisBio Inc.

Brief Summary:
This phase 1 study is a randomized, double-blind, placebo controlled, multiple-dose, dose-escalating study to evaluate the safety, tolerability, PK and PD of D-0120 in healthy volunteers.

Condition or disease Intervention/treatment Phase
Healthy Volunteers Drug: D-0120 Drug: Placebo oral tablet Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description: Double Blind, placebo controlled
Primary Purpose: Other
Official Title: A Phase I, Randomized, Double-Blind, Placebo-Controlled, Multiple-Dose, and Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of D-0120 in Healthy Volunteers
Actual Study Start Date : September 18, 2019
Estimated Primary Completion Date : March 4, 2020
Estimated Study Completion Date : August 24, 2020

Arm Intervention/treatment
Active Comparator: D-0120 Dose Ascending Cohorts 1-4
D-0120 dose daily for up to 7 days.
Drug: D-0120
Randomized, Double-Blind, Placebo-Controlled, Multiple Dose and Dose Escalation of D-0120 or Placebo

Placebo Comparator: Placebo Dose Ascending Cohorts 1-4
Placebo dose daily for up to 7 days
Drug: Placebo oral tablet
Randomized, Double-Blind, Placebo-Controlled, Multiple Dose and Dose Escalation of D-0120 or Placebo

Experimental: D-0120/Uric Acid Lowering Agent Cohort 6
D-0120 in combination with a uric acid lowering agent for up to 7 days of combination therapy
Drug: D-0120
Randomized, Double-Blind, Placebo-Controlled, Multiple Dose and Dose Escalation of D-0120 or Placebo




Primary Outcome Measures :
  1. The number of subjects with treatment related adverse events as assessed [ Time Frame: Reporting of adverse events starts at enrollment through the end of the follow up period (14 days (cohorts 1-4) and 16 days (cohort 6) ]
    Data will include clinical observations, ECG, clinical chemistry/hematology/urinalysis and vital signs


Secondary Outcome Measures :
  1. Time to observed Cmax (Tmax)for D-0120 [ Time Frame: Timeframe: Day 1-Day7 ]
    Blood samples will be collected to assess plasma concentrations of D-0120 at a series of timepoints to derive Tmax

  2. Area under the plasma concentration-time curve (AUC) for D-0120 [ Time Frame: Day 1-Day 7 ]
    Blood samples will be collected to assess plasma concentration of D-0120 at a series of timepoints to derive AUC

  3. Maximum Observed Plasma Concentration (Cmax) of D-0120 [ Time Frame: Day 1-Day 7 ]
    Blood samples will be collect to assess plasma concentrations of D-0120 at a series of timepoints to derive Cmax



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subjects must be medically documented as healthy at physical examination
  • Moderate smokers or non-smokers
  • Subjects must be between the ages of 18 and 60
  • Subject must have a BMI between 18.0 and 30.0 kg/m2 (inclusive)
  • Subjects must have a body weight of 50kg or higher for males and 45kg or higher for females
  • Females must be non-pregnant and non-lactating, and either surgically sterile at least 6 months prior to the first study drug administration or post-menopausal for 12 months or greater
  • Male subjects who are not vasectomized for at least 6 months, and who are sexually active with non-sterile female partner must be willing to use an acceptable contraceptive method throughout the study and for 90 days after the last study drug administration
  • Male subjects with a pregnant partner must agree to use a condom from the first dosing until at least 90 days after the last study administration
  • Subjects must have a complete blood count and platelet count within the normal range
  • Subjects must have a normal urinalysis
  • Subjects must have a normal estimated glomerular filtration rate
  • Subjects must have a normal ECG
  • Subjects must be able to understand the study procedures, risks involved and be able to comply with the study and follow-up procedures
  • Male subjects must be willing not to donate sperm until 90 days following the last study drug administration

Exclusion Criteria:

  • Subjects with any history or clinical manifestations of disorders
  • Subjects who have any history or suspicion of kidney stones
  • Subjects who are HIV, Hep B or Hep C positive
  • History of significant allergic reactions to any drug
  • Clinically significant ECG abnormalities
  • History of significant drug abuse within 1 year prior to screening or use of soft drugs within 3 months prior to screening or hard drugs within 1 year prior to screening
  • Subjects who have used prescription dugs, over the counter drugs or herbal remedies within 14 days before day 1
  • Positive urine drug screen, alcohol breath at screening
  • Subjects had undergone major surgery within 3 months
  • Women who are pregnant or breastfeeding
  • History of significant alcohol abuse
  • Subjects who consumed Seville oranges-or grapefruit-containing food or beverages within 7 days before Day 1 and during the entire study duration.
  • Subjects with any condition that, in the judgement of the investigator, would place him/her at undue risk
  • Participation in a clinical research study involving the administration of an investigation or marketed drug or device within 30 days prior to the first dosing, administration of a biological product in the context of a clinical research study within 90 days prior to first dose
  • Donation of plasma within 7 days prior to dosing

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04097405


Contacts
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Contact: Kathryn Stazzone 302-703-2617 kathryn.stazzone@inventisbio.com
Contact: Ling Zhang, MD, PhD ling.zhang@inventisbio.com

Locations
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United States, Florida
Syneos Health Recruiting
Miami, Florida, United States, 33163
Sponsors and Collaborators
InventisBio Inc.

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Responsible Party: InventisBio Inc.
ClinicalTrials.gov Identifier: NCT04097405     History of Changes
Other Study ID Numbers: IBIO-203
First Posted: September 20, 2019    Key Record Dates
Last Update Posted: September 20, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Uric Acid
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs