A Phase 1, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetic, Pharmacodynamic Profiles Following Single and Multiple Doses and Food Effect of CS12192 Capsules in Healthy Adult Chinese Subjects

Chipscreen Biosciences, Ltd.1 site in 1 country108 target enrollmentJuly 20, 2023

ConditionsHealthy

InterventionsCS12192 capsule Placebo capsule

DrugsCS12192 capsule Placebo capsule

Overview

Phase: Phase 1
Intervention: CS12192 capsule
Conditions: Healthy
Sponsor: Chipscreen Biosciences, Ltd.
Enrollment: 108
Locations: 1
Primary Endpoint: the Number of Adverse Events (AEs)
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The study is to evaluate the safety, tolerability, pharmacokinetic and pharmacodynamic profiles of CS12192 after single or multiple oral administration, as well as the food effect on the pharmacokinetics in healthy subjects.

Detailed Description

This study consists of 3 parts: single ascending dose (SAD), multiple ascending dose (MAD) and food effect (FE). Both SAD and MAD study are randomized, double-blind, placebo-controlled design. The FE study use a randomized, open-label, two-period, two-crossover design.

Registry

clinicaltrials.gov

Start Date

July 20, 2023

End Date

February 1, 2024

Last Updated

2 years ago

Study Type

Interventional

Study Design

Sequential

Sex

All

Investigators

Sponsor

Chipscreen Biosciences, Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Healthy subjects, both male and female.
•Between18 and 45 years of age (inclusive) at screening visit.
•BMI between 19.0-26.0 kg/m2 (including critical value) at screening visit and baseline visit, male subjects' body weight ≥ 50 kg, female subjects' body weight ≥45 kg.
•All subjects and female partners of male agree to use medically recognized effective contraceptive measures (including physical contraception, surgical contraception, abstinence, etc.) from the start of signing informed consent form to 3 months after the last dose.
•Subjects voluntarily participate in the study and sign informed consent form.

Exclusion Criteria

•History of clinically significant drug allergy or atopic allergic diseases (asthma, urticaria, eczematous dermatitis) or drug allergy to investigational products or similar investigational products.
•History of cardiovascular system, endocrine system, nervous system disease or lung, hematological, immunological, psychiatric diseases and metabolic abnormalities.
•History or surgical history of gastrointestinal, hepatic, or renal disease that can affect drug absorption or metabolism within 6 months prior to the screening visit (except uncomplicated appendectomy and hernia repair).
•History of active tuberculosis, or positive tuberculosis screening at screening visit.
•History of any recurrent bacterial, fungal or viral infections (≥3 attacks in the past year, except the common cold), or active infections requiring treatment at screening visit, or history of infection requiring intravenous anti-infective drugs or hospitalization ≤8 weeks before randomization, or history of infection requiring oral anti-infective drugs ≤2 weeks before randomization.
•Uncured diarrhea before randomization, or history of diarrhea within 7 days before planning dosing.
•Use of any prescription drugs, over-the-counter drugs, any vitamin products or Chinese herbal medicines within 1 month before randomization.
•History of drug abuse.
•Inability to tolerate venipuncture, or history of fainting or halo.
•Participation in interventional clinical study (device or drug) within 3 months prior to randomization, or taking investigational product within 3 months prior to randomization , or remaining within 5 half-lives of drug, whichever is longer.