A Study of AK0529 in Chinese Infants Hospitalized With RSV

• Status: Recruiting
• Trial end date: 2022-05-31
• Target enrollment: 0
• Participant gender: All

Summary

This is a randomized, double-blind, placebo-controlled, multicenter, phase III study to be conducted in infants hospitalized with RSV infection in China. The main objectives of this study are to investigate the efficacy and safety of AK0529 in Chinese infants.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ark Biosciences Inc.
• Collaborator: Shanghai Ark Biopharmaceutical Co., Ltd.
• Treatments: Ziresovir

Criteria

Inclusion Criteria:

• Male or female patients of any ethnicity with an age adjusted for any prematurity of ≥1 month and ≤24 months.

• Diagnosis of RSV infection by any virological means within 36 hours preceding initial dosing.

• Onset of RSV infection symptoms should be ≤ 5 days.

• Patient must weigh ≥ 2.5 kg and ≤ 20 kg at screening.

• Patient must have a bronchiolitis score ≥ 5.

• The parent/legal guardian must have provided written informed consent for the patient to participate.

Exclusion Criteria:

• The patient has taken any restricted medications within 3 days prior to the date of screening or requires any restricted medications during treatment phase.

• Patient is known to be HIV-positive (or the mother, if the potential patient is a child aged <6 months).

• Requires vasopressors or inotropic support at the time of enrollment.

• Concurrent gastrointestinal conditions that could seriously, in the opinion of the investigator, prejudice absorption of the Investigational Medicinal Product.

• Bronchopulmonary dysplasia requiring assisted ventilation.

• Patient is at risk for hypercapnia.

• Symptomatic because of inborn errors of metabolism.

• Chronic or persistent feeding difficulties.

• Suspected or known to have congenital acquired immunodeficiency.

• Any active or uncontrolled respiratory, cardiac, hepatic, central nervous system or renal disease unrelated to RSV infection at baseline or any other medical condition that in the opinion of the investigator renders the patient unsuitable for enrollment.

• A history of epilepsy or seizures.

• A history of high allergies.

• The patient's parent or legally acceptable representative is an employee of the investigator or the study center with direct involvement in the proposed study or other studies under the direction of that investigator of the study center, or any family members of the employees or the investigator.

• Participation in an investigational drug or device study within 30 days prior to the date of screening.

• Failure to satisfy the investigator of fitness to participate for any other reason.