Ignite Creation Date:
2025-12-24 @ 5:36 PM
Ignite Modification Date:
2025-12-28 @ 7:33 PM
Study NCT ID:
NCT05083468
Status:
COMPLETED
Last Update Posted:
2024-11-29
First Post:
2021-09-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Safety, Tolerability, and Pharmacokinetics (PK) of SR750 in Healthy Volunteers
Sponsor:
Shanghai SIMR Biotechnology Co., Ltd.
Organization:
Study Overview
Official Title:
A Randomized, Double-blind, Placebo-controlled, 2-part Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Doses of SR750 in Healthy Volunteers
Status:
COMPLETED
Status Verified Date:
2024-11
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 to evaluate the safety, tolerability, and PK of SR750 in healthy volunteers.
Detailed Description:
This study is a randomized, double-blinded, placebo-controlled, 2-part Phase I study to evaluate the safety, tolerability, and pharmacokinetics of single and multiple ascending doses of SR750 in healthy volunteers. This study includes 2 parts:
Part A is a double-blind, randomized, placebo-controlled, single-dose escalation study of SR750 in healthy volunteers.
Part B is a double-blind, randomized, placebo-controlled, repeated-dose escalation study of SR750 in healthy volunteers.
Part A is a double-blind, randomized, placebo-controlled, single-dose escalation study of SR750 in healthy volunteers.
Part B is a double-blind, randomized, placebo-controlled, repeated-dose escalation study of SR750 in healthy volunteers.
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?:
False
Is an FDA AA801 Violation?: