NCT04926116

A Study of AK3280 in Chinese Healthy Volunteers

A Phase I Study to Evaluate The Safety, Tolerability, and Pharmacokinetics of AK3280 in Chinese Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Shanghai Ark Biopharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

This study is a randomized, double-blind, placebo-controlled, single-center, phase I study to evaluate the safety, tolerability, and pharmacokinetics of AK3280 in healthy Chinese subjects.

Detailed description

This phase I study is a randomized, double-blind, placebo-controlled, single-center clinical study in healthy subjects. The objectives of the study are to evaluate the safety, tolerability, and pharmacokinetics of AK3280. Approximately, 36 healthy Chinese subjects will be recruited and randomized to orally receive AK3280 or matching placebo. The total duration of the study will be approximately 25 days for each subject.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	AK3280	Active Substance: AK3280, Pharmaceutical Form: Tablet, Route of Administration: Oral
DRUG	Placebo	Active Substance: Placebo, Pharmaceutical Form: Tablet, Route of Administration: Oral

Timeline

• Start date: 2021-06-09
• Primary completion: 2021-09-28
• Completion: 2021-09-28
• First posted: 2021-06-14
• Last updated: 2022-04-07

Locations

1 site across 1 country: China