Ignite Creation Date:
2025-12-25 @ 4:54 AM
Ignite Modification Date:
2025-12-26 @ 3:54 AM
Study NCT ID:
NCT07106918
Status:
RECRUITING
Last Update Posted:
2025-11-25
First Post:
2025-07-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Clinical Trial of SIBP-A16 Injection in Healthy Adults
Sponsor:
Shanghai Institute Of Biological Products
Organization:
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2025-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: