NCT06534320

Safety, Tolerability and Pharmacokinetic Characteristics Evaluation of DA-302168S Tablets

A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Effects of Food in Single/Multiple Oral Administration of DA-302168S Tablets

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Chendu DIAO Pharmaceutical Group CO., LTD. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

To Evaluate the Safety, Tolerability and Pharmacokinetics on DA-302168S Tablets in Randomized, Double-blind, Placebo-controlled Single-dose and Multiple-dose ascending Phase I Clinical Trials in Healthy Subjects.

Conditions

• Overweight and Obesity

Interventions

Type	Name	Description
DRUG	DA-302168S	SAD study may cotain 7 cohorts at dosage of 2.5 mg, 7.5 mg, 15 mg, 30 mg, 50 mg, 75 mg, 100 mg. Each cohort enrolls 6 subjects receive DA-302168S tablets.
DRUG	Placebo of DA-302168S	SAD study may cotain 7 cohorts at dosage of 2.5 mg, 7.5 mg, 15 mg, 30 mg, 50 mg, 75 mg, 100 mg. Each cohort enrolls 2 subjects receive placebo of DA-302168S tablets.
DRUG	DA-302168S	MAD study may cotain 1-4 cohorts which were evaluated in SAD study to be tolerated . Each cohort enrolls 8 subjects receive study DA-302168S tablets.
DRUG	Placebo of DA-302168S	MAD study may cotain 1-4 cohorts which were evaluated in SAD study to be tolerated . Each cohort enrolls 2 subjects receive study placebo of DA-302168S tablets.

Timeline

• Start date: 2024-04-18
• Primary completion: 2024-12-31
• Completion: 2024-12-31
• First posted: 2024-08-02
• Last updated: 2025-04-15

Locations

1 site across 1 country: China