NCT04352361

Ascending Single-dose Study to Evaluate TVB-2640 in Chinese Healthy Subjects

A Single-dose Study to Investigate the Tolerance and Pharmacokinetics of TVB-2640 Tablets in Chinese Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: Ascletis Pharmaceuticals Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

Ascending oral single-dose study to evaluate the safety and pharmacokinetics of TVB- 2640 tablets in the Chinese healthy population.

Detailed description

This study is designed as a single-center, randomized, single-blind, placebo-controlled, single-dose escalation trial. The dose groups are 25 mg, 50 mg and 75 mg respectively. The next dose should be tested only if the previous dose has demonstrated to be safe and tolerated, and each subject will receive either the experimental drug or a placebo only once.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	TVB-2640	TVB-2640 tablets (25mg/50mg/75mg) one tablet at a time, once per day.
DRUG	Placebo	Oral, matching number of placebo Tablets with active arm.

Timeline

• Start date: 2020-04-02
• Primary completion: 2020-04-29
• Completion: 2020-04-29
• First posted: 2020-04-20
• Last updated: 2020-07-07

Locations

1 site across 1 country: China