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NOT YET RECRUITING
NCT07808918
PHASE1

Safety and Pharmacokinetics of HRS-1597 Tablets in Healthy and Obese Participants: A Phase 1 Study

Sponsor: Shandong Suncadia Medicine Co., Ltd.

View on ClinicalTrials.gov

Summary

This is a Phase 1, single-center, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, and pharmacokinetics of HRS-1597 tablets following single-dose administration in healthy participants and multiple-dose administration in obese participants, as well as the effect of food on the pharmacokinetics of HRS-1597 tablets.

Official title: A Phase 1, Single-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of HRS-1597 Tablets Following Single-Dose Administration in Healthy Participants and Multiple-Dose Administration in Obese Participants, and the Effect of Food on the Pharmacokinetics of HRS-1597 Tablets

Key Details

Gender

All

Age Range

18 Years - 55 Years

Study Type

INTERVENTIONAL

Enrollment

78

Start Date

2026-09

Completion Date

2027-12-30

Last Updated

2026-09-09

Healthy Volunteers

Yes

Interventions

DRUG

HRS-1597

Specified dose on specified days

DRUG

Placebo

Specified dose on specified days

Locations (1)

The First Affiliated Hospital of the University of Science and Technology of China (Anhui Provincial Hospital)

Hefei, Anhui, China