A Study to Confirm the Effectiveness and Safety of AK0529 in Treating RSV Infections in Hospitalized Infants

NCT06775405 | Recruiting Phase 3

• 1 other identifier: AK0529-2007
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 18

Brief 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.

Conditions

Respiratory Synctial Virus Infections

Outcome Measures

Primary Outcomes (1)

• Change from baseline in the Wang bronchiolitis clinical score

  The Wang bronchiolitis clinical score will be used to evaluate respiratory rate, wheezing, respiratory muscle retraction and "general condition" (sleep, feeding, and general status) in subjects with symptoms of bronchiolitis. Each item of the scale is divided into 4 levels according to the severity of symptoms, with 0 point indicating normal and 3 points the highest severity, 12 points in total.

  Day 3 (48 hours)

Secondary Outcomes (9)

• Change from baseline in the Wang bronchiolitis clinical score in subjects younger than 6 months.

  Day 3 (48 hours)

• Time from first treatment to sustained remission of symptoms during the treatment period.

  Study period (up to 14 days)

• Change in RSV VL (viral load) from baseline at each visit.

  Day 2, Day 3, Day 4, Day 5, Day 6, Day 14

• Proportion of subjects with RSV VL below the lower limit of quantitation (LLOQ) at each visit.

  Day 2, Day 3, Day 4, Day 5, Day 6, Day 14

• Time from first treatment to mild disease for subjects, defined as achieving a Wang bronchiolitis clinical score ≤ 3 without the need for supplemental oxygen.

  Study period (up to 14 days)

Study Arms (2)

Active drug

EXPERIMENTAL

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.

Drug: AK0529

Placebo

PLACEBO COMPARATOR

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.

Drug: Placebo

Interventions

AK0529 DRUG

Active Substance: AK0529, Pharmaceutical Form: Enteric pellets, Route of Administration: Oral

Active drug

Placebo DRUG

Active Substance: Placebo, Pharmaceutical Form: Enteric pellets, Route of Administration: Oral

Placebo

Eligibility Criteria

• Age: 1 Month - 24 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• The subject has taken any restricted medications within 3 days prior to the date of screening or requires any restricted medications during treatment phase (including interferons, ribavirin, or proprietary Chinese medicines with antiviral effects) and has taken any inhaled or systemic glucocorticoids within 24 hours.
• Subject is known to have co-infection with influenza virus, Mycoplasma, or other respiratory tract pathogens that require targeted clinical treatment .
• Subject is known to have bacterial pneumonia.
• Subject with clinical evidence of hepatic decompensation (e.g., liver disease with coagulation abnormalities or encephalopathy).
• Subject with inborn symptoms of metabolic abnormalities (e.g., mitochondrial diseases, carbohydrate metabolism abnormalities, glycogen accumulation diseases).
• Subject with chronic or persistent feeding difficulties.
• The parent or guardian of the subject is an employee of the study investigator or the study facility (such person will be directly involved in the study or any other study administered by the study facility investigator), or a family member of the study investigator or his/her staff.
• Subject who have participated in clinical trials of other drugs or devices in the 30 days prior to screening.
• Subject with any other reason that the investigator deems unsuitable for participation in the study.

Sponsors & Collaborators

• Shanghai Ark Biopharmaceutical Co., Ltd.: lead

Study Sites (18)

Beijing Children's Hospital, Capital Medical University

Beijing, China

RECRUITING

Beijing Children's Hospital, Capital Medical University

Beijing, China

RECRUITING

First Hospital of Jilin University

Changchun, China

RECRUITING

Hunan Provincial People's Hospital

Changsha, China

RECRUITING

West China Second University Hospital, Sichuan University

Chengdu, China

RECRUITING

Children's Hospital, Zhejiang University School of Medicine

Hangzhou, China

RECRUITING

Sanya Central Hospital, Hainan Third People's Hospital

Sanya, China

RECRUITING

Shanghai Children's Hospital, Shanghai Jiao Tong University

Shanghai, China

RECRUITING

Shanghai Children's Medical Center, Shanghai Jiao Tong University School of Medicine

Shanghai, China

RECRUITING

Shengjing Hospital of China Medical University

Shenyang, China

RECRUITING

Tianjin Children's Hospital（Longyan）

Tianjin, China

RECRUITING

Tianjin Children's Hospital（Machang）

Tianjin, China

RECRUITING

Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University

Wenzhou, China

RECRUITING

Wuhan Children's Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, China

RECRUITING

Wuxi Children's Hospital

Wuxi, China

RECRUITING

First Affiliated Hospital of Xiamen University

Xiamen, China

RECRUITING

Women and Children's Hospital, and the School of Medicine, Xiamen University

Xiamen, China

RECRUITING

Zhongshan Women and Children's Hospital-Zhongshan Boai Hospital

Zhongshan, China

RECRUITING

MeSH Terms

Interventions

ziresovir

Central Study Contacts

Chao Yu, Master

CONTACT

+86 021-50681677; chao.yu@arkbiosciences.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double-Blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This clinical study is a randomized placebo controlled parallel multi-center phase III trial.

Study Record Dates

• First Submitted: December 16, 2024
• First Posted: January 15, 2025
• Study Start: February 29, 2024
• Primary Completion: August 1, 2025
• Study Completion: September 1, 2025
• Last Updated: January 15, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (18)