Effect of AK0529 on RSV infections in hospitalized infants

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

This study is testing a new drug called AK0529 to see if it can help hospitalized infants with RSV infections feel better.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 180 (estimated)
• Ages: 1 Month to 24 Months
• Sex: All
• Sponsor: Shanghai Ark Biopharmaceutical Co., Ltd. (Industry-sponsored)
• Locations: 18 sites (Beijing and 17 other locations)
• Trial ID: NCT06775405 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effectiveness and safety of AK0529, a drug targeting the fusion protein of the respiratory syncytial virus (RSV), in treating hospitalized infants aged 1 to 24 months with RSV infections. The study is a randomized, double-blind, placebo-controlled, multicenter Phase III trial that aims to enroll 180 infants. Participants will receive either AK0529 or a placebo twice daily for five days, with regular assessments of their clinical condition and safety monitoring throughout the study period. The primary endpoint is the improvement in bronchiolitis symptoms as measured by the Wang bronchiolitis clinical score.

Who should consider this trial

Good fit: Ideal candidates are hospitalized infants aged 1 to 24 months diagnosed with RSV infection within the last 5 days.

Not a fit: Patients with co-infections or those who have taken restricted medications shortly before the study may not benefit from this treatment.

Why it matters

Potential benefit: If successful, this treatment could significantly reduce the severity of RSV infections in infants, potentially lowering hospitalization rates and improving outcomes.

How similar studies have performed: Other studies targeting RSV have shown promise, but the specific approach of using AK0529 is novel and has not been previously tested.

Eligibility criteria

Main Inclusion criteria:

1. Male or female subjects of any ethnicity with an age adjusted for any prematurity of ≥1 month and ≤24 months.
2. Diagnosis of RSV infection by any virological means, including a rapid diagnostic point-of-care testing, within 36 hours preceding initial dosing.
3. The onset of RSV infection symptoms should be ≤ 5 days prior to initial dosing.
4. 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.
5. Subject must have a Wang bronchiolitis clinical score ≥ 5.

Main Exclusion criteria:

1. 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.
2. Subject is known to have co-infection with influenza virus, Mycoplasma, or other respiratory tract pathogens that require targeted clinical treatment .
3. Subject is known to have bacterial pneumonia.
4. Subject with clinical evidence of hepatic decompensation (e.g., liver disease with coagulation abnormalities or encephalopathy).
5. Subject with inborn symptoms of metabolic abnormalities (e.g., mitochondrial diseases, carbohydrate metabolism abnormalities, glycogen accumulation diseases).
6. Subject with chronic or persistent feeding difficulties.
7. 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.
8. Subject who have participated in clinical trials of other drugs or devices in the 30 days prior to screening.
9. Subject with any other reason that the investigator deems unsuitable for participation in the study.

Where this trial is running

Beijing and 17 other locations

• 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)

Study contacts

• Study coordinator: Chao Yu, Master

Conditions Respiratory Synctial Virus Infections