Ignite Creation Date:
2025-12-24 @ 10:08 PM
Ignite Modification Date:
2025-12-25 @ 7:44 PM
Study NCT ID:
NCT05497635
Status:
COMPLETED
Last Update Posted:
2023-04-18
First Post:
2022-08-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study of STSA-1002 in Healthy Subjects
Sponsor:
Staidson (Beijing) Biopharmaceuticals Co., Ltd
Organization:
Study Overview
Official Title:
A Randomized,Double-blind, Placebo-controlled, Multiple Ascending-Dose Phase Ib Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of STSA-1002 Injection in Healthy Subjects
Status:
COMPLETED
Status Verified Date:
2023-04
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 Phase Ib, randomized, double-blind, placebo-controlled, multiple dose, dose escalation safety, tolerability,pharmacokinetic and pharmacodynamic study of STSA-1002 injection in healthy subjects. A total of 26 healthy subjects were enrolled in three dosage groups.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
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?: