Clinical Trial

Phase Ib/IIa Clinical Trial of SIBP-A16 Injection in Premature Infants and Full-term Infants

Name: Phase Ib/IIa Clinical Trial of SIBP-A16 Injection in Premature Infants and Full-term Infants — clinical trial record (NCT07363837)
Creator: DataLookout
License: https://creativecommons.org/licenses/by/4.0/

Not Yet Recruiting Phase 1/2

View on ClinicalTrials.gov →

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.

Trial Details

NCT Number	NCT07363837
Lead Sponsor	Shanghai Institute Of Biological Products
Conditions	Respiratory Syncytial Virus (RSV)
Enrollment	36 participants
Start Date	2026-01-15
Primary Completion	2027-03-31 (estimated)
Study Completion	2027-03-31 (estimated)
Updated on ClinicalTrials.gov	2026-01-23