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Anti-human CCL24 monoclonal antibody- Part One

Phase 1

Nonalcoholic Fatty Liver Disease | Small molecule | Metabolic |Chemomab Therapeutics Ltd.|Last Updated: Sep 21, 2023

Target and mechanism

ModalitySmall molecule

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

Clinical trial landscape

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 Disease
NCT0604446716
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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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