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

Sponsor

InventisBio Co., Ltd (Industry)

Overall Status

Completed

CT.gov ID

NCT04097405

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

2.9

Patients Per Site Per Month

Study Details

Study Description

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

Study Design

Study Type:

Interventional

Actual Enrollment :

40 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 :

Sep 18, 2019

Actual Primary Completion Date :

Mar 30, 2020

Actual Study Completion Date :

Nov 18, 2020

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

The number of subjects with treatment related adverse events as assessed [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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Syneos Health	Miami	Florida	United States	33163

Sponsors and Collaborators

InventisBio Co., Ltd

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

InventisBio Co., Ltd

ClinicalTrials.gov Identifier:

NCT04097405

Other Study ID Numbers:

IBIO-203

First Posted:

Sep 20, 2019

Last Update Posted:

Feb 10, 2021

Last Verified:

Feb 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Feb 10, 2021