NCT06942299

A Study of AK0529 in Adults Patients Hospitalized With RSV Infection

A Randomized, Double-blind, Placebo-controlled Study Evaluating the Pharmacokinetics, Safety, and Efficacy of Multiple Doses AK0529 in Adult Hospitalized Subjects With Respiratory Syncytial Virus Infection

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Shanghai Ark Biopharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

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

Conditions

• Respiratory Syncytial Virus Infections

Interventions

Type	Name	Description
DRUG	AK0529	Active Substance: AK0529, Pharmaceutical Form: Enteric pellets, Route of Administration: Oral, fasting
DRUG	AK0529	Active Substance: AK0529, Pharmaceutical Form: Enteric pellets, Route of Administration: Oral with meal
DRUG	Placebo	Active Substance: Placebo, Pharmaceutical Form: Enteric pellets, Route of Administration: Oral with meal or fasting

Timeline

• Start date: 2023-07-20
• Primary completion: 2024-06-28
• Completion: 2024-06-28
• First posted: 2025-04-24
• Last updated: 2025-04-24

Locations

42 sites across 1 country: China