NCT05369078

Safety, Tolerance and Pharmacokinetics of THR-1442 in Chinese Healthy Subjects

Phase I Clinical Study to Evaluate the Safety, Tolerance and Pharmacokinetics of THR-1442 in Chinese Healthy Subjects

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (estimated)
• Sponsor: Newsoara Biopharma Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study was to investigate Safety, tolerability and pharmacokinetics in Chinese healthy subjects.

Detailed description

This was a single center, Phase 1, open-label SAD and MAD study designed to assess safety, tolerability and PK of orally administered THR-1442 tablets in Chinese healthy adults. Subjects were enrolled to receive 20mg THR-1442 tablet in Single dose group (20mg\*1 day) and multiple dose group(20mg\*7days). Blood samples for THR-1442 plasma concentrations were collected 0h till to 48hours.

Conditions

• T2DM (Type 2 Diabetes Mellitus)

Interventions

Type	Name	Description
DRUG	THR-1442 20mg Single dose	THR-1442 20mg is administrated 1 dose on Day 1, then follow till day 7.
DRUG	THR-1442 20mg Multiple dose group	THR-1442 20mg is administrated QD for 7days, then follow till day 14.

Timeline

• Start date: 2021-12-01
• Primary completion: 2022-05-31
• Completion: 2022-05-31
• First posted: 2022-05-11
• Last updated: 2022-05-11

Locations

1 site across 1 country: China