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

NCT04097405 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: IBIO-203
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Time to observed Cmax (Tmax)for D-0120

  Timeframe: Day 1-Day7

• Area under the plasma concentration-time curve (AUC) for D-0120

  Day 1-Day 7

• Maximum Observed Plasma Concentration (Cmax) of D-0120

  Day 1-Day 7

Study Arms (3)

D-0120 Dose Ascending Cohorts 1-4

ACTIVE COMPARATOR

D-0120 dose daily for up to 7 days.

Drug: D-0120

Placebo Dose Ascending Cohorts 1-4

PLACEBO COMPARATOR

Placebo dose daily for up to 7 days

Drug: Placebo oral tablet

D-0120/Uric Acid Lowering Agent Cohort 6

EXPERIMENTAL

D-0120 in combination with a uric acid lowering agent for up to 7 days of combination therapy

Drug: D-0120

Interventions

D-0120 DRUG

Randomized, Double-Blind, Placebo-Controlled, Multiple Dose and Dose Escalation of D-0120 or Placebo

D-0120 Dose Ascending Cohorts 1-4; D-0120/Uric Acid Lowering Agent Cohort 6

Placebo oral tablet DRUG

Randomized, Double-Blind, Placebo-Controlled, Multiple Dose and Dose Escalation of D-0120 or Placebo

Placebo Dose Ascending Cohorts 1-4

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• InventisBio Co., Ltd: lead

Study Sites (1)

Syneos Health

Miami, Florida, 33163, United States

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Double Blind, placebo controlled
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2019
• First Posted: September 20, 2019
• Study Start: September 18, 2019
• Primary Completion: March 30, 2020
• Study Completion: November 18, 2020
• Last Updated: February 10, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)