NCT02297594

Safety, Tolerability and PK Study of AK0529 in Healthy Human

A Randomized, Double-blind, Placebo-controlled, Single and Multiple Ascending Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of AK0529 When Administered Orally in Healthy Male and Female Adult Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 74 (actual)
• Sponsor: Shanghai Ark Biopharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to assess the safety, tolerability and PK of single and multiple ascending dose of AK0529 when administered orally in healthy subjects

Detailed description

This is a Phase 1, first-in-man, single-center, randomized, double blind, placebo controlled single and multiple ascending dose study in healthy male and female volunteers.

Conditions

• Respiratory Syncytial Virus Infections

Interventions

Type	Name	Description
DRUG	AK0529	AK0529 capsule for oral administration
DRUG	Placebo	Sugar placebo capsule for oral administration

Timeline

• Start date: 2014-10-01
• Primary completion: 2015-06-01
• Completion: 2015-06-01
• First posted: 2014-11-21
• Last updated: 2015-10-20

Locations

1 site across 1 country: Australia