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

NCT06044467 | Completed Phase 1 DMC

• 1 other identifier: CM-101-I-002
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Nonalcoholic Fatty Liver Disease

Outcome Measures

Primary Outcomes (2)

• Incidence and characteristics of adverse events (AEs) occurring following multiple doses

  Incidence and characteristics of adverse events (AEs) occurring following multiple doses

  Up to 18 weeks

• Evaluation of the development of anti-drug antibodies (ADA) - Study Part 1

  Evaluation of the development of anti-drug antibodies (ADA) following repeated administrations of CM-101 -

  Up to 18 weeks

Secondary Outcomes (20)

• Plasma Pharmacokinetics (PK) parameters of CM-101 following multiple administrations - Maximum CM-101 plasma concentration (Cmax) - Study Part 1

  Up to 18 weeks

• Plasma Pharmacokinetics (PK) parameters of CM-101 - Time to Cmax (tmax) - Study Part 1

  Up to 18 weeks

• Plasma Pharmacokinetics (PK) parameters of CM-101 - Area under the curve (AUC) to the final concentration ≥ limit of quantitation (LOQ), AUC(0-t) and to infinity AUCinf - Study Part 1

  Up to 18 weeks

• Plasma Pharmacokinetics (PK) parameters of CM-101 following multiple administrations - Terminal elimination rate constant (λz) - Study Part 1

  Up to 18 weeks

• Plasma Pharmacokinetics (PK) parameters of CM-101 following multiple administrations - Terminal elimination half-life (T½) - Study Part 1

  Up to 18 weeks

Study Arms (4)

Anti-human CCL24 monoclonal antibody (CM-101) - study Part One

EXPERIMENTAL

Anti-human CCL24 monoclonal antibody (CM-101) NAFLD subjects that have normal liver functions - (Cohort 1: 2.5 mg/kg intravenously and Cohort 2: 5.0 mg/kg subcutaneously)

Drug: Anti-human CCL24 monoclonal antibody (CM-101) - Part One

Placebo - Study Part One

PLACEBO COMPARATOR

Placebo Comparator

Drug: Placebo - Study Part One

Anti-human CCL24 monoclonal antibody (CM-101) - Study Part Two

EXPERIMENTAL

Anti-human CCL24 monoclonal antibody (CM-101) NAFLD/NASH patients with NAS \< 3 that are in general good health and have normal liver functions - 2.5 mg/kg intravenous infusion

Drug: Anti-human CCL24 monoclonal antibody (CM-101) - Part Two

Placebo - Study Part Two

PLACEBO COMPARATOR

Placebo Comparator

Drug: Placebo - Study Part Two

Interventions

Anti-human CCL24 monoclonal antibody (CM-101) - Part One DRUG

Anti-human CCL24 monoclonal antibody (CM-101) - Part One

Anti-human CCL24 monoclonal antibody (CM-101) - study Part One

Anti-human CCL24 monoclonal antibody (CM-101) - Part Two DRUG

Anti-human CCL24 monoclonal antibody (CM-101) - Part Two

Anti-human CCL24 monoclonal antibody (CM-101) - Study Part Two

Placebo - Study Part One DRUG

Placebo Comparator

Placebo - Study Part One

Placebo - Study Part Two DRUG

Placebo Comparator

Placebo - Study Part Two

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with US confirmation of NAFLD without evidence of NASH;
• Patients with normal liver function tests (i.e. ALT, AST and ALP).
• Patients in general good health expected for the preceding 6 months;
• Women of childbearing potential must agree to use an approved form of contraception prior to study entry and for the duration of study participation through 60 days after the last dose of the study medication. Confirmation that female patients are not pregnant must be established by a negative serum β-human chorionic gonadotropin (β-hCG) pregnancy test result obtained during screening. Pregnancy testing is not required for postmenopausal or surgically sterilized women;
• Male patients must agree to use a barrier method of contraception or abstinence for the duration of study participation through 60 days after the last dose of the study medication;
• Patient must be able to read, understand, and sign the informed consent forms (ICF), communicate with the investigator, and understand and comply with protocol requirements

You may not qualify if:

• Patients with medical/surgical history of gastric bypass surgery, orthotopic liver transplant (OLT) or patients that are planned for such interventions;
• Documented history of chronic liver disease (e.g., autoimmune hepatitis (\>1:160 ANA with histologic features), Wilson's disease, Hemochromatosis (Ferritin \>500 ug/L and percent iron saturation \>45%), Primary Biliary Cholangitis, Primary Sclerosing Cholangitis, Alcoholic Liver Disease);
• Presence of chronic viral hepatitis:
• Chronic hepatitis B virus (HBV) infection (hepatitis B surface antigen (HBsAg) positive);
• Chronic hepatitis C virus (HCV) infection (HCV Ab and HCV ribonucleic acid (HCV RNA) positive).
• Patients cured of HCV infection less than 5 years prior to the Screening visit are not eligible;
• History of or current diagnosis of HCC;
• Known human immunodeficiency virus (HIV) infection (HIV Ab and HIV ribonucleic acid (HIV RNA) positive);
• Patients with diabetes mellitus type 1;
• Patients with uncontrolled diabetes mellitus type 2, i.e. HbA1c ≥ 9% (75 mmol/mol) at the time of screening or patients that are treated with insulin;
• Patients treated with chronic medication including but not limited to anti-retrovirals, tamoxifen, methotrexate, cyclophosphamide, isotretinoin, bile acid binding resins, or pharmacologic doses of oral glucocorticoids (≥10 mg of prednisone per day or equivalent) within the 12 weeks of screening;
• Patients treated with the below listed medications can be enrolled into the study if these medications are deemed medically necessary, cannot be stopped and the investigator anticipates their dose will remain stable during the study:
• Stable doses of anti-diabetic medications (e.g. metformin, sulfonylureas, SGLT2 inhibitors, glitazones (thiazolidinediones), dipeptidyl peptidase-4 inhibitors and glucagon-like peptide-1 analogs) for at least 6 months prior to screening.
• Stable doses of ACE inhibitors, angiotensin II receptor antagonists, beta-blockers and thiazide diuretics for at least 6 months prior to screening.
• Stable doses of fibrates, statins, niacin, ezetimibe for at least 6 months prior to screening.

Sponsors & Collaborators

• ChemomAb Ltd.: lead

Study Sites (1)

Hadassah University Hospital - Ein Kerem

Jerusalem, 91120, Israel

Location

Related Publications (1)

• Mor A, Friedman S, Hashmueli S, Peled A, Pinzani M, Frankel M, Safadi R. Targeting CCL24 in Inflammatory and Fibrotic Diseases: Rationale and Results from Three CM-101 Phase 1 Studies. Drug Saf. 2024 Sep;47(9):869-881. doi: 10.1007/s40264-024-01436-2. Epub 2024 Jun 1.

  PMID: 38822943 DERIVED

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Interventions

streptococcal polysaccharide type III group B

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Study Officials

• Arnon Aharon, MD

  ChemomAb Ltd.

  STUDY CHAIR

• Rifaat Safadi, MD

  Hadassah University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 30, 2023
• First Posted: September 21, 2023
• Study Start: December 11, 2018
• Primary Completion: April 27, 2020
• Study Completion: April 27, 2020
• Last Updated: September 21, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)