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RECRUITING
NCT07230418
PHASE1

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Food Effect of Single and Multiple Doses of HRS-3095 Oral Administration in Healthy Subjects, as Well as the Effect of HRS-3095 on CYP3A4 Metabolic Enzymes

Sponsor: Chengdu Suncadia Medicine Co., Ltd.

View on ClinicalTrials.gov

Summary

The study is being conducted to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single and multiple doses of HRS-3095 oral administration in healthy subjects. This study will also explore food effect and the effect of HRS-3095 on CYP3A4 metabolic enzymes.

Official title: A Double-blind, Randomized, Dose-escalation Phase I Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Food Effect of Single and Multiple Doses of HRS-3095 Oral Administration in Healthy Subjects, as Well as the Effect of HRS-3095 on CYP3A4 Metabolic Enzymes

Key Details

Gender

All

Age Range

18 Years - 55 Years

Study Type

INTERVENTIONAL

Enrollment

66

Start Date

2025-11-10

Completion Date

2026-02

Last Updated

2025-12-03

Healthy Volunteers

Yes

Interventions

DRUG

HRS-3095 Tablet

Oral HRS-3095 tablet.

DRUG

HRS-3095 Placebo Tablet

Oral HRS-3095 placebo tablet.

Locations (1)

The Frist Clinical Medicial College of Qingdao University

Qingdao, Shandong, China