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NOT YET RECRUITING
NCT07363837
PHASE1/PHASE2

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

Sponsor: Shanghai Institute Of Biological Products

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.

Official title: A Randomized, Double-blind, Placebo/Positive Control, Dose-finding Phase Ib/IIa Clinical Trial Evaluating the Safety, Tolerability, and Pharmacokinetics of SIBP-A16 Injection in Premature Infants and Full-term Infants

Key Details

Gender

All

Age Range

0 Months - 12 Months

Study Type

INTERVENTIONAL

Enrollment

36

Start Date

2026-01-15

Completion Date

2027-03-31

Last Updated

2026-01-23

Healthy Volunteers

Yes

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.

Locations (1)

West China Second Hospital, Sichuan University

Chengdu, Sichuan, China