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RECRUITING
NCT07106918
EARLY_PHASE1

A Clinical Trial of SIBP-A16 Injection in Healthy Adults

Sponsor: Shanghai Institute Of Biological Products

View on ClinicalTrials.gov

Summary

This study is a randomized, double-blind, placebo/positive control Phase Ia clinical trial evaluating the safety, tolerability, and pharmacokinetics of SIBP-A16 injection in healthy adults

Official title: A Randomized, Double-blind, Placebo/Positive Control Phase Ia Clinical Trial Evaluating the Safety, Tolerability, and Pharmacokinetics of SIBP-A16 Injection in Healthy Adults

Key Details

Gender

All

Age Range

18 Years - 45 Years

Study Type

INTERVENTIONAL

Enrollment

140

Start Date

2025-08-17

Completion Date

2027-04-30

Last Updated

2025-11-25

Healthy Volunteers

Yes

Interventions

BIOLOGICAL

SIBP-A16 injection

Single administration via intramuscular or intravenous injection. All participants received a single injection of the corresponding dose.

BIOLOGICAL

Nirsevimab

Single administration via intramuscular.

OTHER

SIBP-A16 buffer solution

Single administration via intramuscular or intravenous injection. All participants received a single injection of the corresponding dose.

Locations (1)

Wuhan Jinyintan Hospital

Wuhan, China