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Anti-human CCL24 monoclonal antibody- Part One

Phase 1

Nonalcoholic Fatty Liver Disease | Monoclonal antibody | Metabolic |Chemomab Therapeutics Ltd.|Trials Updated: Sep 21, 2023

Anti-human CCL24 monoclonal antibody- Part One target and mechanism

ModalityMonoclonal antibody

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

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment16

FDA Designations

No designations recorded

Anti-human CCL24 monoclonal antibody- Part One clinical trials

Anti-human CCL24 monoclonal antibody- Part One · 1 trial · 1 indication

Phase 1 1
NCT06044467The Study of Multiple Doses of CM-101 in Male and Female NAFLD (Nonalcoholic Fatty Liver Disease) and NAFLD/NASH (Nonalcoholic Steatohepatitis) SubjectsNonalcoholic Fatty Liver Disease
COMPLETED16 Analytics
PHASE1COMPLETED
The Study of Multiple Doses of CM-101 in Male and Female NAFLD (Nonalcoholic Fatty Liver Disease) and NAFLD/NASH (Nonalcoholic Steatohepatitis) Subjects
Nonalcoholic Fatty Liver DiseaseUnlock trial analytics

Study Endpoints

Primary Endpoints

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
Up to 18 weeks

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

Secondary Endpoints

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
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Anti-human CCL24 monoclonal antibody (CM-101) - study Part OneEXPERIMENTALAnti-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)
Placebo - Study Part OnePLACEBO_COMPARATORPlacebo Comparator
Anti-human CCL24 monoclonal antibody (CM-101) - Study Part TwoEXPERIMENTALAnti-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
Placebo - Study Part TwoPLACEBO_COMPARATORPlacebo Comparator

Interventions

NameTypeDescription
Anti-human CCL24 monoclonal antibody (CM-101) - Part OneDRUGAnti-human CCL24 monoclonal antibody (CM-101) - Part One
Anti-human CCL24 monoclonal antibody (CM-101) - Part TwoDRUGAnti-human CCL24 monoclonal antibody (CM-101) - Part Two
Placebo - Study Part OneDRUGPlacebo Comparator
Placebo - Study Part TwoDRUGPlacebo Comparator
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Eligibility Criteria

Age Range18 Years to 75 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: 1. Patients with US confirmation of NAFLD without evidence of NASH; 2. Patients with normal liver function tests (i.e. ALT, AST and ALP). 3. Patients in general good health expected for the preceding 6 months; 4. Women of childbearing potential must agree to use an approved form...

Countries:Israel
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Frequently asked questions about Anti-human CCL24 monoclonal antibody- Part One

What is anti-human CCL24 monoclonal antibody (CM-101) - Part One?

Anti-human CCL24 monoclonal antibody (CM-101) - Part One is an investigational monoclonal antibody developed by Chemomab Therapeutics Ltd. (ticker CMMB) for Nonalcoholic Fatty Liver Disease. It is also known as CM-101. The antibody targets human CCL24 and was studied in a Phase 1 clinical trial.

What is anti-human CCL24 monoclonal antibody (CM-101) - Part One used for?

Anti-human CCL24 monoclonal antibody (CM-101) - Part One is being developed for the treatment of Nonalcoholic Fatty Liver Disease, a metabolic liver condition. It is an investigational therapy and has not been approved for any indication. The completed Phase 1 trial enrolled patients with NAFLD and NAFLD/NASH.

What does anti-human CCL24 monoclonal antibody (CM-101) - Part One target?

Anti-human CCL24 monoclonal antibody (CM-101) - Part One targets human CCL24, a chemokine also known as eotaxin-2. By binding to CCL24, the monoclonal antibody is designed to block its activity. This mechanism is being investigated in the context of Nonalcoholic Fatty Liver Disease.

Who is developing anti-human CCL24 monoclonal antibody (CM-101) - Part One?

Anti-human CCL24 monoclonal antibody (CM-101) - Part One is being developed by Chemomab Therapeutics Ltd., a biotechnology company whose ticker symbol is CMMB. Chemomab is responsible for the clinical development of CM-101 for Nonalcoholic Fatty Liver Disease.

What phase is anti-human CCL24 monoclonal antibody (CM-101) - Part One in?

Anti-human CCL24 monoclonal antibody (CM-101) - Part One is in Phase 1 development. A Phase 1 trial has been completed. The drug is investigational and has not been approved by the FDA or any regulatory agency for Nonalcoholic Fatty Liver Disease or any other indication.

What clinical trials is anti-human CCL24 monoclonal antibody (CM-101) - Part One in?

Anti-human CCL24 monoclonal antibody (CM-101) - Part One has been studied in one completed Phase 1 clinical trial, NCT06044467, titled "The Study of Multiple Doses of CM-101 in Male and Female NAFLD and NAFLD/NASH Subjects." The trial enrolled 16 participants in Israel and was randomized, double-blind, and placebo-controlled.