NCT07482657 A Phase 2 Study to Investigate the Efficacy and Safety of Zelicapavir in Participants Aged ≥28 Days to ≤36 Months of Age Infected With Respiratory Syncytial Virus
| NCT ID | NCT07482657 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Enanta Pharmaceuticals, Inc |
| Condition | RSV Infection |
| Study Type | INTERVENTIONAL |
| Enrollment | 150 participants |
| Start Date | 2026-07-09 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 150 participants in total. It began in 2026-07-09 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Zelicapavir is a novel, orally administered, nonfusion replication inhibitor of RSV. It is being investigated in this Phase 2 study (EDP 938-203) as a potential treatment for RSV infection in both hospitalized and non-hospitalized children aged ≥28 days to ≤36 months who present with symptomatic RSV infection.
Eligibility Criteria
Inclusion Criteria: * Participants diagnosed with RSV infection using an approved diagnostic assay, without known and/or documented coinfection with SARS-CoV-2 or influenza * Participant has signs of RSV infection with onset ≤3 days (72 hours) at the time of randomization * In the Investigator's opinion, the participant's caregiver understands and is able to comply with protocol requirements, instructions, and restrictions, and the participant is likely to complete the study as planned. The caregiver(s) should be of legal age. Exclusion Criteria: * Participant has any condition that in the opinion of the Investigator would interfere with the evaluation of the study drug or participant safety. * Participant has underlying immune deficiency. Participants with immunoglobulin A deficiency are not excluded. * Participant has had major surgery within 6 weeks prior to randomization or has major surgery planned during the course of the study. * Participant is currently taking either chronically or has taken within 7 days prior to randomization, or is anticipated to receive during the course of the study, systemic medications that are known to cause immunosuppression other than corticosteroids for \>5 days. * Participant has received an investigational agent within the last 30 days or 5 half-lives of the investigational agent, whichever is longer.
Contact & Investigator
Enanta Pharmaceuticals, Inc
STUDY DIRECTOR
Enanta Pharmaceuticals, Inc
Frequently Asked Questions
Who can join the NCT07482657 clinical trial?
This trial is open to participants of all sexes, aged 28 Days or older, up to 36 Months, studying RSV Infection. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07482657 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07482657 currently recruiting?
Yes, NCT07482657 is actively recruiting participants. Contact the research team at charris@enanta.com for enrollment information.
Where is the NCT07482657 trial being conducted?
This trial is being conducted at Bangkok, Thailand, Chiang Mai, Thailand, Chiang Mai, Thailand, Chiang Rai, Thailand and 4 additional locations.
Who is sponsoring the NCT07482657 clinical trial?
NCT07482657 is sponsored by Enanta Pharmaceuticals, Inc. The principal investigator is Enanta Pharmaceuticals, Inc at Enanta Pharmaceuticals, Inc. The trial plans to enroll 150 participants.