NCT07106918

A Clinical Trial of SIBP-A16 Injection in Healthy Adults

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

• Status: Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 140 (estimated)
• Sponsor: Shanghai Institute Of Biological Products · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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

Detailed description

This study plans to set up 5 queues, with queues 1, 3, 4, and 5 each containing 20 participants in the experimental group and 4 participants in the placebo group. Queue 2 contains 20 participants in the experimental group, 20 participants in the positive control group, and 4 participants in the placebo group. The total number of participants included in the five queues is 140. SIBP-A16 injection and placebo will be administered in four different doses and two different ways of administration. The study adopted a sequential injection design. After completing a 14-day preliminary safety observation of drug administration in the previous group, the Safety Review Committee (SRC) will conduct a preliminary safety assessment. Once the SRC evaluation results are safe (not meeting the dose escalation termination criteria), the next group will be enrolled.

Conditions

• Respiratory Syncytial Virus (RSV)

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-08-17
• Primary completion: 2027-04-30
• Completion: 2027-04-30
• First posted: 2025-08-06
• Last updated: 2025-11-25

Locations

1 site across 1 country: China