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

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Drug: D-0120; Drug: Placebo oral tablet

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33163
      • Syneos Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The number of subjects with treatment related adverse events as assessed	Data will include clinical observations, ECG, clinical chemistry/hematology/urinalysis and vital signs	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)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to observed Cmax (Tmax)for D-0120	Blood samples will be collected to assess plasma concentrations of D-0120 at a series of timepoints to derive Tmax	Timeframe: Day 1-Day7
Area under the plasma concentration-time curve (AUC) for D-0120	Blood samples will be collected to assess plasma concentration of D-0120 at a series of timepoints to derive AUC	Day 1-Day 7
Maximum Observed Plasma Concentration (Cmax) of D-0120	Blood samples will be collect to assess plasma concentrations of D-0120 at a series of timepoints to derive Cmax	Day 1-Day 7

Collaborators and Investigators

• Sponsor: InventisBio Co., Ltd

Study record dates

Study Major Dates

• Study Start (Actual): September 18, 2019
• Primary Completion (Actual): March 30, 2020
• Study Completion (Actual): November 18, 2020

Study Registration Dates

• First Submitted: September 18, 2019
• First Submitted That Met QC Criteria: September 19, 2019
• First Posted (Actual): September 20, 2019

Study Record Updates

• Last Update Posted (Actual): February 10, 2021
• Last Update Submitted That Met QC Criteria: February 8, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: IBIO-203

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No