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A Clinical Trial of SIBP-A16 Injection in Healthy Adults

NCT07106918 · Status: RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 140

Last updated 2025-11-25

No results posted yet for this study

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

Conditions

  • Respiratory Syncytial Virus (RSV)

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.

Sponsors & Collaborators

  • Shanghai Institute Of Biological Products

    lead INDUSTRY

Principal Investigators

  • Chao lin Huang · Wuhan Jinyintan Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-08-17
Primary Completion
2027-04-30
Completion
2027-04-30

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 NCT07106918 on ClinicalTrials.gov