NCT04231968

A Study of AK0529 in Chinese Infants Hospitalized With RSV

A Randomized, Double-blind, Placebo-controlled, 2-part Study of Orally Administered AK0529 to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics and Antiviral Effect of Multiple Doses in Hospitalized Infants With Respiratory Syncytial Virus Infection

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 311 (actual)
• Sponsor: Shanghai Ark Biopharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 1 Month – 24 Months
• Healthy volunteers: Not accepted

Summary

This is a randomized, double-blind, placebo-controlled, multicenter, phase III study to be conducted in infants hospitalized with RSV infection in China. The main objectives of this study are to investigate the efficacy and safety of AK0529 in Chinese infants.

Conditions

• Respiratory Syncytial Virus Infections

Interventions

Type	Name	Description
DRUG	AK0529	AK0529 capsule will be orally administered at the twice-daily dosing levels of 10 mg, 20 mg, or 40 mg for five days based on the patient's weight.
DRUG	Matching placebo of AK0529	The placebo capsule was made with the same smell and appearance as AK0529 but without the active ingredients and will be orally administered per the same treatment schedule as those in the experimental arm.

Timeline

• Start date: 2020-09-22
• Primary completion: 2022-01-21
• Completion: 2022-02-02
• First posted: 2020-01-18
• Last updated: 2024-02-13

Locations

28 sites across 1 country: China