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

NCT07363837 · Status: NOT_YET_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2026-01-23

No results posted yet for this study

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.

Conditions

  • Respiratory Syncytial Virus (RSV)

Interventions

DRUG

SIBP-A16 injection

Strength: dose 1, dose 2 and dose 3. Single administration via intramuscular or intravenous injection.

DRUG

Nirsevimab

Participants will receive one dose of Nisibimab via intramuscular injection.

DRUG

SIBP-A16 buffer solution

Participants in the placebo group will be assigned to four dose cohorts, and they will receive one dose of Placebo via intramuscular injection.

Sponsors & Collaborators

  • Shanghai Institute Of Biological Products

    lead INDUSTRY

Principal Investigators

  • Hanwen Liu · West China Second Hospital, Sichuan University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
0 Months
Max Age
12 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-01-15
Primary Completion
2027-03-31
Completion
2027-03-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07363837 on ClinicalTrials.gov