drugset / Trial / NCT07363837
Phase Ib/IIa Clinical Trial of SIBP-A16 Injection in Premature Infants and Full-term Infants
RandomizedParallel-groupQuadruple-blindPrevention
Summary
This trial employs a randomized, double-blind, placebo/positive control, and dose-finding design to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity, and preliminary efficacy of SIBP-A16 injection in premature and term infants.
Timeline
- Start
- 2026-01-15
- Primary completion
- 2027-03-31
- Completion
- 2027-03-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Nirsevimab | Monoclonal antibody | — | Intramuscular |
| Subject | SIBP-A16 | Unknown | — | Intramuscular |