Ignite Creation Date:
2025-12-25 @ 12:46 AM
Ignite Modification Date:
2025-12-28 @ 9:21 PM
Study NCT ID:
NCT06044467
Status:
COMPLETED
Last Update Posted:
2023-09-21
First Post:
2023-08-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Study of Multiple Doses of CM-101 in Male and Female NAFLD (Nonalcoholic Fatty Liver Disease) and NAFLD/NASH (Nonalcoholic Steatohepatitis) Subjects
Sponsor:
ChemomAb Ltd.
Organization:
Study Overview
Official Title:
A Phase 1B, Repeated Dose Study, to Evaluate the Safety, PD and PK Profile of CM-101 in NAFLD Patients With Normal Liver Function Tests and Stable NAFLD/NASH Patients With NAFLD Activity Score (NAS) < 3-The SPARK Study
Status:
COMPLETED
Status Verified Date:
2023-09
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:
A two-part study for NAFLD subjects with normal liver functions and in general good health to be treated with CM-101 or matching placebo and NAFLD/NASH Activity Score (NAS) \< 3 that are in general good health and have normal liver functions to be treated with CM-101.
Detailed Description:
This study is designed to assess the safety and preliminary pharmacodynamics of repeated administrations of CM-101 in two subject populations. The objective of part one of this study is to demonstrate that repeated treatment with CM-101 will be safe and well tolerated in NAFLD subjects that have normal liver functions and are in general good health. A second expansion part will be carried out that will include patients with NAFLD/NASH Activity Score (NAS) \< 3 that are in general good health and have normal liver functions.
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?: