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CM-101 in NASH Patients - The SPLASH Study

NCT05824156 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2023-04-21

No results posted yet for this study

Summary

This phase 2a study is a multi-center, double-blind randomized, placebo-controlled study. The study is designed to determine the safety and tolerability of the anti-human CCL24 monoclonal antibody CM-101 in adult patients with non-cirrhotic nonalcoholic steatohepatitis (NASH) patients with stage 1c, 2 or 3 fibrosis. The patients will be randomized to 1 of 2 treatment groups: 5 mg/kg CM-101 or placebo.

Conditions

Interventions

BIOLOGICAL

5 mg/kg CM-101

CM-101, Monoclonal Ab blocking CCL24

OTHER

Placebo

Placebo

Sponsors & Collaborators

  • ChemomAb Ltd.

    lead INDUSTRY

Principal Investigators

  • Matthew Frankel, MD · ChemomAb Ltd.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-02-24
Primary Completion
2022-08-15
Completion
2022-08-25

Countries

  • Israel

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05824156 on ClinicalTrials.gov