A Randomized, Double-blind, Placebo-controlled, Phase III Confirmatory Study to Evaluate the Efficacy, Safety, Tolerability, and Antiviral Activity of Repeated Oral Administration of AK0529 in Hospitalized Infants with Respiratory Syncytial Virus Infection
Status: Recruiting
Location: See all (18) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
Respiratory syncytial virus (RSV) is the most common respiratory infectious pathogen recognized worldwide that poses serious health risks to infants, and an important cause of hospitalization for severe respiratory infections in infants. Serious respiratory problems such as pneumonia caused by RSV are one of the leading causes of death from respiratory diseases in infants. AK0529 targets the Pre-F (fusion) protein on the surface of the viral envelope. Specifically, it prevents the virus from invading uninfected cells and inhibits the fusion between host cells by inhibiting the fusion of the F (fusion) proteins on the surface of the RSV envelope, thus providing the effects of anti-RSV infection. This is a randomized, double-blind, placebo-controlled, multicenter, phase III clinical study to evaluate the efficacy and safety of AK0529 in hospitalized infants aged 1 to 24 months with RSV infection. Considering the benefits of AK0529 in the population with RSV infection, hospitalized infants with moderate to severe RSV infection were selected as the target population for this study.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 1 month
Maximum Age: 2
Healthy Volunteers: f
View:
• Male or female subjects of any ethnicity with an age adjusted for any prematurity of ≥1 month and ≤24 months.
• Diagnosis of RSV infection by any virological means, including a rapid diagnostic point-of-care testing, within 36 hours preceding initial dosing.
• The onset of RSV infection symptoms should be ≤ 5 days prior to initial dosing.
• Subject must weigh ≥ 2.5 kg and ≤ 20 kg at screening and be within the normal range for the subject's age, based on local child growth standards.
• Subject must have a Wang bronchiolitis clinical score ≥ 5.
Locations
Other Locations
China
Beijing Children's Hospital, Capital Medical University
RECRUITING
Beijing
Beijing Children's Hospital, Capital Medical University
RECRUITING
Beijing
First Hospital of Jilin University
RECRUITING
Changchun
Hunan Provincial People's Hospital
RECRUITING
Changsha
West China Second University Hospital, Sichuan University
RECRUITING
Chengdu
Children's Hospital, Zhejiang University School of Medicine
RECRUITING
Hangzhou
Sanya Central Hospital, Hainan Third People's Hospital
RECRUITING
Sanya
Shanghai Children's Hospital, Shanghai Jiao Tong University
RECRUITING
Shanghai
Shanghai Children's Medical Center, Shanghai Jiao Tong University School of Medicine
RECRUITING
Shanghai
Shengjing Hospital of China Medical University
RECRUITING
Shenyang
Tianjin Children's Hospital（Longyan）
RECRUITING
Tianjin
Tianjin Children's Hospital（Machang）
RECRUITING
Tianjin
Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University
RECRUITING
Wenzhou
Wuhan Children's Hospital, Tongji Medical College, Huazhong University of Science and Technology
RECRUITING
Wuhan
Wuxi Children's Hospital
RECRUITING
Wuxi
First Affiliated Hospital of Xiamen University
RECRUITING
Xiamen
Women and Children's Hospital, and the School of Medicine, Xiamen University
RECRUITING
Xiamen
Zhongshan Women and Children's Hospital-Zhongshan Boai Hospital
RECRUITING
Zhongshan
Contact Information
Primary
Chao Yu, Master
chao.yu@arkbiosciences.com
+86 021-50681677
Time Frame
Start Date:2024-02-29
Estimated Completion Date:2025-09
Participants
Target number of participants:180
Treatments
Experimental: Active drug
The participants will receive AK0529 of 10 mg, 20 mg or 40 mg based on body weight twice daily for 5 days from D1 to D5.
Placebo_comparator: Placebo
The participants will receive placebo of 10 mg, 20 mg or 40 mg based on body weight twice daily for 5 days from D1 to D5.