NCT06044467

The Study of Multiple Doses of CM-101 in Male and Female NAFLD (Nonalcoholic Fatty Liver Disease) and NAFLD/NASH (Nonalcoholic Steatohepatitis) Subjects

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
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: ChemomAb Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Nonalcoholic Fatty Liver Disease

Interventions

Type	Name	Description
DRUG	Anti-human CCL24 monoclonal antibody (CM-101) - Part One	Anti-human CCL24 monoclonal antibody (CM-101) - Part One
DRUG	Anti-human CCL24 monoclonal antibody (CM-101) - Part Two	Anti-human CCL24 monoclonal antibody (CM-101) - Part Two
DRUG	Placebo - Study Part One	Placebo Comparator
DRUG	Placebo - Study Part Two	Placebo Comparator

Timeline

• Start date: 2018-12-11
• Primary completion: 2020-04-27
• Completion: 2020-04-27
• First posted: 2023-09-21
• Last updated: 2023-09-21

Locations

1 site across 1 country: Israel