Study Details

OVERVIEW

A Phase 2, Randomized, Multicenter, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of Obeldesivir in Participants From Birth to < 5 Years of Age With Respiratory Syncytial Virus (RSV) Infection

PROTOCOL SUMMARY

The goal of this clinical study is to check if obeldesivir (ODV; GS-5245) is safe and well-tolerated by children with respiratory syncytial virus (RSV) infection. It will also look at how well ODV helps reduce the time it takes for children to feel better and for their RSV symptoms to improve. The primary objectives of this study are: a) to evaluate the safety and tolerability of ODV in pediatric participants with RSV infection; b) To evaluate the efficacy of ODV on time to alleviation of targeted RSV symptoms in pediatric participants with RSV infection.

Participation Requirements

Age

0 - 5 Years

Sex

ALL

Healthy Volunteers

Medical Condition

RSV Infection

Gender

N/A

Date

January 2025 - April 2026

Study Type

INTERVENTIONAL

Study Phase

PHASE2

Product

Obeldesivir, Obeldesivir Placebo

Eligibility Information

Inclusion Criteria

Participants assigned male or female at birth, from birth to < 5 years of age who meet one of the following criteria, where permitted according to local law and approved nationally and by relevant institutional review board or independent ethics committee:
Cohort 1: Infants and children from 4 weeks postnatal age, weighing ≥ 1.5 kg to < 40 kg
Cohort 2: Neonates, either born at term or preterm, weighing ≥ 1.5 kg to < 6 kg
RSV infection diagnosis ≤ 3 days prior to randomization.
Negative test for influenza A/B, and SARS-CoV-2 infection ≤ 7 days prior to randomization.
Onset of RSV signs or symptoms ≤ 3 days prior to randomization.
Presence of at least 1 sign or symptom of RSV infection at screening and at randomization.

Exclusion Criteria

Currently requiring or expected to require hospitalization for RSV infection within 48 hours after randomization.
Documented previous infection and/or hospitalization for RSV during the current respiratory virus season.
Diagnosed with acute concurrent active systemic infections requiring treatment with systemic antiviral, antibacterial, antifungal, or antimycobacterial therapy, or with any documented respiratory viral infection (other than RSV), ≤ 7 days prior to randomization.
History of asthma or recurrent wheezing.
Neuromuscular disease that affects swallowing.
Cystic fibrosis.
Participants who are immunocompromised.
Alanine aminotransferase ≥ 5 × upper limit of normal (ULN).
Abnormal renal function.
Concurrent or previous treatment with other agents with actual or possible direct antiviral activity against RSV, received within 28 days or within 5 half-lives, whichever is longer, prior to randomization.
Received palivizumab within 100 days, or nirsevimab within 1 year, or other RSV specific monoclonal antibody within 5 half-lives of the antibody, prior to randomization.
Participant whose mother received RSV vaccination during pregnancy and who is < 1 year old prior to randomization.
Note: Other protocol defined Inclusion/Exclusion criteria may apply.