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
1 other identifier
interventional
25
1 country
42
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Jul 2023
Shorter than P25 for phase_2
42 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 24, 2023
CompletedStudy Start
First participant enrolled
July 20, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 28, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
June 28, 2024
CompletedFirst Posted
Study publicly available on registry
April 24, 2025
CompletedApril 24, 2025
April 1, 2025
11 months
March 24, 2023
April 16, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Incidence and severity of AE and SAE of subjects during the study period
An Adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect, or another important medical event.
Baseline up to 28 days
Secondary Outcomes (18)
Change from baseline in clinical improvement score of subjects at each visit after treatment by clinical improvement scale
Baseline up to 28 days
Change from baseline in RiiQ symptoms of subjects at each visit after treatment measured by RiiQ questionnaire
Baseline up to 28 days
Changes from baseline in the total score of RSV Symptom of subjects at each visit after treatment using RSV Symptom Score Composite Scale
Baseline up to 28 days
Changes from baseline in the RSV VL (viral load) of subjects at each visit after treatment
Baseline up to 28 days
Area under the curve (AUCE, last) of RSV Viral Load from baseline to the last measurement
Baseline up to 28 days
- +13 more secondary outcomes
Study Arms (3)
Active drug: AK0529 fasting
EXPERIMENTALThe participants will receive AK0529 twice daily for 5 days from D1 to D5.
Active drug: AK0529 with meal
EXPERIMENTALThe participants will receive AK0529 twice daily for 5 days from D1 to D5.
Placebo
PLACEBO COMPARATORPlacebo
Interventions
Eligibility Criteria
You may qualify if:
- Male or female patients of any ethnicity with an age of 18-85 years.
- Diagnosis of RSV infection by any virological means within 36 hours preceding initial dosing.
- At least one of the following high-risk diseases or states for RSV infection
- Asthma or chronic lung disease (such as COPD or cystic fibrosis),
- immunocompromised,
- Heart disease (such as congenital heart disease, congestive, heart failure, or coronary artery disease), except high blood, pressure without heart-related symptoms,
- Chronic kidney disease,
- Age ≥65 years old.
- With at least 1 new onset respiratory infection symptom or exacerbation of existing respiratory symptoms (respiratory symptoms include: sore throat, nasal congestion, runny nose, sneezing, coughing, wheezing, sputum production, shortness of breath), and any individual score is 2 or moderate.
- Onset of RSV infection symptoms should be ≤ 7 days.
You may not qualify if:
- days for drugs with potential antiviral effects on RSV such as ordinary interferon, 8 days for long-acting interferon, and 35 days for ribavirin for 5 half-lives before expected administration.
- Prohibited medicine are being used or planned to be used during the study treatment periods.
- Severe gastrointestinal diseases that affect the absorption of study drugs (such as vomiting, malabsorption syndrome, short bowel syndrome due to necrotizing enterocolitis, etc.).
- Received or planned to have bone marrow transplantation, stem cell transplantation or solid organ transplantation within 1 year.
- Patients with malignant tumors who had surgery within recent 6 months and/or requiring radiotherapy, chemotherapy and biological immunotherapy.
- Patients with autoimmune diseases who are in the induction treatment.
- HIV infection, CD4 count\< 350 cells/mm3 with opportunistic infection and need treatment.
- Other patients who are judged by the investigator to be unsuitable for participating in the study, such as acute/chronic heart, lung, liver, kidney, rheumatic immunity, psychiatric, blood and other diseases in the unstable period.
- History of drug abuse within 12 months prior to screening.
- Allergy to the investigational drug or its component.
- Female patients with positive pregnancy test or breastfeeding.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (42)
The Second Perople's Hospital of Hefei
Hefei, Anhui, China
Huangshan City People's Hospital
Huangshan City, Anhui, China
Peking University Shougang Hospital
Beijing, Beijing Municipality, 100000, China
Beijing Hospital
Beijing, Beijing Municipality, 100005, China
China-Japan Friendship Hospital
Beijing, Beijing Municipality, 100029, China
The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, 350004, China
Quanzhou First Hospital
Quanzhou, Fujian, China
Gansu People's Hospital
Lanzhou, Gansu, China
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, 510120, China
Guangzhou Panyu Central Hospital
Guangzhou, Guangdong, 511486, China
Longgang Central Hospital of Shenzhen
Shenzhen, Guangdong, 518116, China
Shunde Hospital of Southern Medical University
Shunde, Guangdong, 528399, China
Central People's Hospital of Zhanjiang
Zhanjiang, Guangdong, 524037, China
The Second Nanning People's Hospital
Nanning, Guangxi, China
Guizhou People's Hospital
Guiyang, Guizhou, China
Hebei Chest Hospital
Shijiazhuang, Hebei, China
Harbin Medical University Affiliated Fourth Hospital
Harbin, Heilongjiang, China
The Second Affiliated Hospital of Heilongjiang University of Traditional Chinese Medicine
Harbin, Heilongjiang, China
The Sixth People's Hospital of Zhengzhou
Zhengzhou, Henan, China
Wuhan Fourth Hospital
Wuhan, Hubei, China
Xiangyang Center Hospital
Xiangyang, Hubei, China
Yueyang Central Hospital
Yueyang, Hunan, China
Changzhou Second People's Hospital
Changzhou, Jiangsu, 213004, China
Jiangsu Provincial Hospital of Chinese Medicine
Nanjing, Jiangsu, 210004, China
The First Affilited Hospital of Nanchang University
Nanchang, Jiangxi, China
Jilin Province People's Hospital
Changchun, Jilin, China
The First Clinical College / Liaoning Hospital of TCM
Shenyang, Liaoning, China
Inner Mongolia Autonomous Region People's Hospital
Hohhot, Neimenggu, China
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, China
Weifang NO.2 People's Hospital
Weifang, Shandong, China
Tongji Hospital of Tongji University
Shanghai, Shanghai Municipality, 200065, China
Yueyang Hospital Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine
Shanghai, Shanghai Municipality, 200437, China
Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
Shanghai, Shanghai Municipality, 201203, China
Sencond Hospital of Shanxi Medical University
Taiyuan, Shanxi, China
The First Affiliated Hospital of Xi'an Medical University
Xi’an, Shanxi, China
Chengdu Seventh People's Hospital
Chengdu, Sichuan, 610044, China
The First Hospital of Kunming
Kunming, Yunnan, China
The First People's Hospital of Yunnan Province
Kunming, Yunnan, China
Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang, 314408, China
Ningbo First Hospital
Ningbo, Zhejiang, 315010, China
Shaoxing People's Hospital
Shaoxing, Zhejiang, 312035, China
Taizhou Hospital of Zhejiang Province
Taizhou, Zhejiang, 317099, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Masking Details
- Double-Blind
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 24, 2023
First Posted
April 24, 2025
Study Start
July 20, 2023
Primary Completion
June 28, 2024
Study Completion
June 28, 2024
Last Updated
April 24, 2025
Record last verified: 2025-04
Data Sharing
- IPD Sharing
- Will not share