Ignite Creation Date:
2025-12-25 @ 2:41 AM
Ignite Modification Date:
2025-12-31 @ 4:22 AM
Study NCT ID:
NCT07016633
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-06-13
First Post:
2025-05-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
To Evaluate the Tolerability, Pharmacokinetics, and Pharmacodynamics of IMM-H014 in Patients With MASH
Sponsor:
Changchun Intellicrown Pharmaceutical Co. LTD
Organization:
Study Overview
Official Title:
A Phase Ib/IIa, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Tolerability, Pharmacokinetics, and Pharmacodynamics of IMM-H014 Consecutive Multiple Treatment for 12 Weeks in Adult Patients With MASH
Status:
NOT_YET_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 study will evaluate the tolerability, pharmacokinetics, and pharmacodynamics of consecutive Multiple treatment for 12 weeks（84 Days） in Adult Patients with Metabolic Dysfunction-Associated Steatohepatitis. Participants will receive either IMM-H014 or placebo.
Detailed Description:
The study is a randomized, double-blind phase Ib/IIa trial. Subjects will receive 125mg, 225mg, 325mg and 400mg (Group 1, Group 2, Group 3 and Group 4). Each group will consist of 10 participants who will be randomly assigned to receive IMM-H014 and placebo in a ratio of 4:1(8 receiving the investigational drug and 2 receiving placebo). Administer D1-D84 on an empty stomach or after breakfast once a day for 84 consecutive days (12 weeks).
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?: