Clinical trial NCT06942299: A Study of AK0529 in Adults Patients Hospitalized With RSV Infection
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Respiratory Syncytial Virus Infections
Keywords: Adult patient with RSV infection
High-risk disease
AK0529
Lead sponsor: Shanghai Ark Biopharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2025-04-24
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This clinical study is a randomized placebo controlled parallel multi-center phase II trial.
Primary purpose: TREATMENT

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.


Eligibility criteria: Main Inclusion criteria:

1. . Male or female patients of any ethnicity with an age of 18-85 years.
2. . Diagnosis of RSV infection by any virological means within 36 hours preceding initial dosing.
3. . At least one of the following high-risk diseases or states for RSV infection

   1. Asthma or chronic lung disease (such as COPD or cystic fibrosis),
   2. immunocompromised,
   3. Heart disease (such as congenital heart disease, congestive, heart failure, or coronary artery disease), except high blood, pressure without heart-related symptoms,
   4. Chronic kidney disease,
   5. Age ≥65 years old.
4. . 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.
5. . Onset of RSV infection symptoms should be ≤ 7 days.

Main Exclusion criteria:

1. . 3 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.
2. . Prohibited medicine are being used or planned to be used during the study treatment periods.
3. . Severe gastrointestinal diseases that affect the absorption of study drugs (such as vomiting, malabsorption syndrome, short bowel syndrome due to necrotizing enterocolitis, etc.).
4. . Received or planned to have bone marrow transplantation, stem cell transplantation or solid organ transplantation within 1 year.
5. . Patients with malignant tumors who had surgery within recent 6 months and/or requiring radiotherapy, chemotherapy and biological immunotherapy.
6. . Patients with autoimmune diseases who are in the induction treatment.
7. . HIV infection, CD4 count\< 350 cells/mm3 with opportunistic infection and need treatment.
8. . 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.
9. . History of drug abuse within 12 months prior to screening.
10. . Allergy to the investigational drug or its component.
11. . Female patients with positive pregnancy test or breastfeeding.

Primary outcomes:
measure: Incidence and severity of AE and SAE of subjects during the study period
timeFrame: Baseline up to 28 days
Secondary outcomes:
measure: Change from baseline in clinical improvement score of subjects at each visit after treatment by clinical improvement scale
timeFrame: Baseline up to 28 days
measure: Change from baseline in RiiQ symptoms of subjects at each visit after treatment measured by RiiQ questionnaire
timeFrame: Baseline up to 28 days
measure: Changes from baseline in the total score of RSV Symptom of subjects at each visit after treatment using RSV Symptom Score Composite Scale
timeFrame: Baseline up to 28 days
measure: Changes from baseline in the RSV VL (viral load) of subjects at each visit after treatment
timeFrame: Baseline up to 28 days
measure: Area under the curve (AUCE, last) of RSV Viral Load from baseline to the last measurement
timeFrame: Baseline up to 28 days
measure: Number of subjects with RSV VL values below the lower limit of quantitation (LLOQ) at each visit after treatment
timeFrame: Baseline up to 28 days
measure: Number of participants who dropped out of the study due to AE
timeFrame: Baseline up to 28 days
measure: Number of participants with laboratory examination abnormalities
timeFrame: Baseline up to 28 days
measure: Number of participants with vital sign abnormalities
timeFrame: Baseline up to 28 days
measure: Number of participants with physical examination abnormalities
timeFrame: Baseline up to 28 days
measure: Number of participants with ECG abnormalities
timeFrame: Baseline up to 28 days
measure: Peak Plasma Concentration (Cmax)
timeFrame: Day 1, Day 5
measure: Time to Maximum Plasma Concentration (Tmax)
timeFrame: Day 1，Day 5
measure: Terminal Elimination Half-life (t½)
timeFrame: Day 1，Day 5
measure: Apparent Clearance (CL/F)
timeFrame: Day 1，Day 5
measure: Apparent Volume of Distribution (V[z]/F)
timeFrame: Day 1，Day 5
measure: Area Under the Plasma Concentration-Time Curve From Time 0 to 12 (AUC[0-12])
timeFrame: Day 1，Day 5
measure: Area Under the Plasma Concentration-Time Curve From Time 0 Extrapolated to Infinity (AUC[0-∞])
timeFrame: Day 1，Day 5
Other outcomes:
Locations:
city: Hefei
country: China
facility: The Second Perople's Hospital of Hefei
state: Anhui
city: Huangshan
country: China
facility: Huangshan City People's Hospital
state: Anhui
city: Beijing
country: China
facility: Peking University Shougang Hospital
state: Beijing
city: Beijing
country: China
facility: Beijing Hospital
state: Beijing
city: Beijing
country: China
facility: China-Japan Friendship Hospital
state: Beijing
city: Fuzhou
country: China
facility: The First Affiliated Hospital of Fujian Medical University
state: Fujian
city: Quanzhou
country: China
facility: Quanzhou First Hospital
state: Fujian
city: Lanzhou
country: China
facility: Gansu People's Hospital
state: Gansu
city: Guangzhou
country: China
facility: The First Affiliated Hospital of Guangzhou Medical University
state: Guangdong
city: Guangzhou
country: China
facility: Guangzhou Panyu Central Hospital
state: Guangdong
city: Shenzhen
country: China
facility: Longgang Central Hospital of Shenzhen
state: Guangdong
city: Shunde
country: China
facility: Shunde Hospital of Southern Medical University
state: Guangdong
city: Zhanjiang
country: China
facility: Central People's Hospital of Zhanjiang
state: Guangdong
city: Nanning
country: China
facility: The Second Nanning People's Hospital
state: Guangxi
city: Guiyang
country: China
facility: Guizhou People's Hospital
state: Guizhou
city: Shijiazhuang
country: China
facility: Hebei Chest Hospital
state: Hebei
city: Ha'erbin
country: China
facility: Harbin Medical University Affiliated Fourth Hospital
state: Heilongjiang
city: Ha'erbin
country: China
facility: The Second Affiliated Hospital of Heilongjiang University of Traditional Chinese Medicine
state: Heilongjiang
city: Zhengzhou
country: China
facility: The Sixth People's Hospital of Zhengzhou
state: Henan
city: Wuhan
country: China
facility: Wuhan Fourth Hospital
state: Hubei
city: Xiangyang
country: China
facility: Xiangyang Center Hospital
state: Hubei
city: Yueyang
country: China
facility: Yueyang Central Hospital
state: Hunan
city: Changzhou
country: China
facility: Changzhou Second People's Hospital
state: Jiangsu
city: Nanjing
country: China
facility: Jiangsu Provincial Hospital of Chinese Medicine
state: Jiangsu
city: Nanchang
country: China
facility: The First Affilited Hospital of Nanchang University
state: Jiangxi
city: Changchun
country: China
facility: Jilin Province People's Hospital
state: Jilin
city: Shenyang
country: China
facility: The First Clinical College / Liaoning Hospital of TCM
state: Liaoning
city: Hohhot
country: China
facility: Inner Mongolia Autonomous Region People's Hospital
state: Neimenggu
city: Qingdao
country: China
facility: The Affiliated Hospital of Qingdao University
state: Shandong
city: Weifang
country: China
facility: Weifang NO.2 People's Hospital
state: Shandong
city: Shanghai
country: China
facility: Tongji Hospital of Tongji University
state: Shanghai
city: Shanghai
country: China
facility: Yueyang Hospital Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine
state: Shanghai
city: Shanghai
country: China
facility: Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
state: Shanghai
city: Taiyuan
country: China
facility: Sencond Hospital of Shanxi Medical University
state: Shanxi
city: Xi'an
country: China
facility: The First Affiliated Hospital of Xi'an Medical University
state: Shanxi
city: Chendu
country: China
facility: Chengdu Seventh People's Hospital
state: Sichuan
city: Kunming
country: China
facility: The First Hospital of Kunming
state: Yunnan
city: Kunming
country: China
facility: The First People's Hospital of Yunnan Province
state: Yunnan
city: Hangzhou
country: China
facility: Zhejiang Provincial People's Hospital
state: Zhejiang
city: Ningbo
country: China
facility: Ningbo First Hospital
state: Zhejiang
city: Shaoxing
country: China
facility: Shaoxing People's Hospital
state: Zhejiang
city: Taizhou
country: China
facility: Taizhou Hospital of Zhejiang Province
state: Zhejiang
Study officials:
References: