NCT03322800

A Study of AK0529 to Evaluate Pharmacokinetics and Safety in Chinese Healthy Volunteers

A Randomised, Double-blind, Placebo-controlled, Phase I Study of Orally Administered AK0529 in Chinese Healthy Adult Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 51 (actual)
• Sponsor: Shanghai Ark Biopharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

This study will characterize the pharmacokinetics (PK) of AK0529, the effect of food and evaluate the safety of AK0529 in healthy Chinese adult subjects. 50 subjects will be randomized to receive a dose level of AK0529 or placebo in five groups. The total study duration will be approximately 18-27 days for each subject.

Detailed description

This is a randomized, double-blind, placebo-controlled, single-center, Phase I study in healthy Chinese subjects. The objectives of the study are to evaluate the safety of AK0529, characterize the PK of AK0529 and to evaluate the effect of food in healthy Chinese subjects. 50 healthy Chinese subjects will be randomized to orally receive one of four dose levels of AK0529 (single dose:100 mg and 300 mg, Multiple dose: 600 mg, Cross-over Food Effect: 300 mg) or placebo. The total duration of the study will be approximately 18 to 27 days for each subject.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	AK0529	Active Substance: AK0529, Pharmaceutical Form: Capsule, Route of Administration: Oral
OTHER	Placebo	Active Substance: Placebo, Pharmaceutical Form: Capsule, Route of Administration: Oral

Timeline

• Start date: 2017-10-23
• Primary completion: 2018-04-06
• Completion: 2018-05-24
• First posted: 2017-10-26
• Last updated: 2021-06-09

Locations

1 site across 1 country: China