Ignite Creation Date:
2025-12-25 @ 2:09 AM
Ignite Modification Date:
2026-01-01 @ 6:23 AM
Study NCT ID:
NCT07024160
Status:
RECRUITING
Last Update Posted:
2025-07-03
First Post:
2025-06-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase I Study of MT1011 Injection in Healthy Subjects
Sponsor:
Shaanxi Micot Pharmaceutical Technology Co., Ltd.
Organization:
Study Overview
Official Title:
A Single-center, Randomized, Double-blind, Placebo-controlled Phase I Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Ascending Dose (SAD) Administration of MT1011 Injection in Healthy Subjects
Status:
RECRUITING
Status Verified Date:
2025-05
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 is a single-center, randomized,double-blind, placebo-controlled Phase I study to evaluate safety, PK and PD of single ascending dose (SAD) of MT1011 injection in healthy adult subjects. Includes 5 dose cohorts, with 40 subjects planned for enrollment.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
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?: