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TERMINATED
NCT03699202
PHASE2

Anti-RSV Study in Chinese Patients (ASCENT)

Sponsor: Shanghai Ark Biopharmaceutical Co., Ltd.

View on ClinicalTrials.gov

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

Interventions

DRUG

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.

DRUG

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