NCT06025851

Intravenous Doses of CM-101 as a Treatment for Medical Conditions Involving Inflammatory and Fibrotic Mechanisms in Healthy Male Subjects

A Double-Blind, Randomized, Placebo-Controlled, Phase I Study to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Escalating Intravenous Doses of CM-101 in Healthy Male Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: ChemomAb Ltd. · Industry
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The study is designed to investigate the safety and tolerability of CM-101 for the treatment of medical conditions involving inflammatory and fibrotic mechanisms such as non-alcoholic steatohepatitis (NASH) and primary sclerosing cholangitis (PSC) and systemic sclerosis (SSc).

Detailed description

A total of 32 male subjects were enrolled into the study and randomized to 4 treatment groups. The study was comprised of a screening period, a treatment day, a follow-up (FU) period of 42 days and an end of study (EOS) FU visit. In each Dose Group subjects was randomized to receive a single IV infusion of CM-101.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Anti-human CCL24 monoclonal antibody (CM-101)	Intravenous Infusion of Anti-human CCL24 monoclonal antibody (CM-101)
DRUG	Placebo	Placebo Comparator

Timeline

• Start date: 2017-07-24
• Primary completion: 2018-02-18
• Completion: 2018-02-18
• First posted: 2023-09-06
• Last updated: 2023-09-11

Locations

1 site across 1 country: Israel