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Anti-RSV Study in Chinese Patients (ASCENT)
Sponsor: Shanghai Ark Biopharmaceutical Co., Ltd.
Summary
This is a randomised, double-blind, placebo-controlled, multicentre, phase 2 study to evaluate the efficacy, safety and tolerability of orally administered AK0529 in Chinese adults with RSV infection.
Official title: A Randomised, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety and Tolerability of Orally Administered AK0529 in Adults With Respiratory Syncytial Virus Infection
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
1
Start Date
2019-03-28
Completion Date
2019-04-04
Last Updated
2026-06-22
Healthy Volunteers
No
Conditions
Interventions
AK0529
AK0529 is a novel compound being developed for the treatment of RSV infection. The capsule containing enteric coated AK0529 pellets will be orally administered to patients at one of a 100mg, 200mg or 300mg dose level.
Placebo
The placebo is made with the same smell and appearance as AK0529 but without the active ingredients. The placebo supplements are composed of microcrystaline cellulose pellet.
Locations (22)
Beijing Ditan Hospital
Beijing, Beijing Municipality, China
Beijing Anzhen Hospital
Beijing, Beijing Municipality, China
Quanzhou First Hospital
Quanzhou, Fujian, China
Huizhou Municipal Central Hospital
Huizhou, Guangdong, China
The Second Affiliated Hospital of Hainan Medical University
Haikou, Hainan, China
Sanya Central Hospital
Sanya, Hainan, China
The Second Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
Nanjing First Hospital
Nanjing, Jiangsu, China
Jiangsu Taizhou People's Hospital
Taizhou, Jiangsu, China
Qingdao Municipal Hospital
Qingdao, Shandong, China
People's Hospital of Deyang City
Deyang, Sichuan, China
Suining Central Hopital
Suining, Sichuan, China
China-Japan Friendship Hospital
Beijing, China
Beijing Pinggu Hospital
Beijing, China
The First Affiliated Hospital of Bengbu Medical College
Bengbu, China
Nantong First People's Hospital
Nantong, China
Shanghai East Hospital
Shanghai, China
Central Hospital of Minhang District, Shanghai
Shanghai, China
Shenzhen People's Hospital
Shenzhen, China
Xiangtan Central Hospital
Xiangtan, China
Xinxiang First People's Hospital
Xinxiang, China
Affiliated Hospital of Zunyi Medical University
Zunyi, China