RSV infection
Conditions
Interventions
Experimental: Obeldesivir (ODV)
-Participants will receive an age and weight appropriate ODV dose based on their cohort/group assignment.
-Administered orally
Experimental: Obeldesivir Placebo
-Parti
Sponsors
Kamiya Makoto
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Participants assigned male or female at birth, from birth to = 1.5 kg to = 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
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), = 5 times 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs) Through Day 28 Percentage of Participants Experiencing Grade 3 or 4 Treatment-emergent laboratory abnormalities by Day 28 Time to Alleviation of Targeted RSV Symptoms by Day 28 | — |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetic (PK) parameter AUCtau of ODV metabolite, GS-441524 PK parameter Cmax of ODV metabolite, GS-441524 PK parameter Ctrough of ODV metabolite, GS-441524 Change From Baseline in RSV Nasal Swab Viral Load at Day 5 Time to Sustained Alleviation of Targeted RSV Symptoms by Day 28 Time to Resolution of Targeted RSV Symptoms by Day 28 Assessment of Palatability and Acceptability Scores of Age-specific Formulation as Assessed by Caregiver at Days 1 and 5 | — |
Countries
Japan, United States
Contacts
Public ContactClinical Operations
Gilead Sciences, K.K.
Outcome results
None listed