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

InventisBio Co., Ltd1 site in 1 country40 target enrollmentSeptember 18, 2019

ConditionsHealthy Volunteers

InterventionsD-0120 Placebo oral tablet

DrugsD-0120 Placebo oral tablet

Overview

Phase: Phase 1
Intervention: D-0120
Conditions: Healthy Volunteers
Sponsor: InventisBio Co., Ltd
Enrollment: 40
Locations: 1
Primary Endpoint: The number of subjects with treatment related adverse events as assessed
Status: Completed
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

September 18, 2019

End Date

November 18, 2020

Last Updated

5 years ago

Study Type

Interventional

Study Design

Sequential

Sex

All

Investigators

Sponsor

InventisBio Co., Ltd

Responsible Party

Sponsor

Eligibility 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

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