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CM-101

Phase 1

Nonalcoholic Steatohepatitis (NASH) | Small molecule | Immunology |Chemomab Therapeutics Ltd.|Last Updated: Sep 14, 2023

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment8

FDA Designations

No designations recorded

Clinical trial landscape

CM-101 · 1 trial · 3 indications

Phase 1 1
NCT06037577Subcutaneous Doses of CM-101 as a Treatment for Medical Conditions Involving Inflammatory and Fibrotic Mechanisms in Healthy Male SubjectsNonalcoholic Steatohepatitis (NASH)
COMPLETED8 Analytics
PHASE1COMPLETED
Subcutaneous Doses of CM-101 as a Treatment for Medical Conditions Involving Inflammatory and Fibrotic Mechanisms in Healthy Male Subjects
Nonalcoholic Steatohepatitis (NASH)Unlock trial analytics

Study Endpoints

Primary Endpoints

Incidence and characteristics of adverse events (AEs)
10 weeks

Incidence and characteristics of adverse events (AEs) occurring following single subcutaneous doses of CM-101

Plasma pharmacokinetic (PK) of CM-101 - Maximum CM-101 plasma concentration (Cmax)
10 weeks

Maximum CM-101 plasma concentration (Cmax)

Plasma pharmacokinetic (PK) of CM-101 - Time to Cmax (tmax)
10 weeks

Time to Cmax (tmax)

Plasma pharmacokinetic (PK) of CM-101 - Area under the curve (AUC) to the final concentration ≥ limit of quantitation (LOQ), AUC(0-t) and to infinity AUCinf
10 weeks

Area under the curve (AUC) to the final concentration ≥ limit of quantitation (LOQ), AUC(0-t) and to infinity AUCinf

Plasma pharmacokinetic (PK) of CM-101 - Terminal elimination rate constant (λz)
10 weeks

Terminal elimination rate constant (λz)

Plasma pharmacokinetic (PK) of CM-101 - Terminal elimination half-life (T½)
10 weeks

Terminal elimination half-life (T½)

Secondary Endpoints

Assessment, based on the safety profile within the tested doses range of CM-101 - dose-limiting toxicity (DLT)
10 weeks
Assessment, based on the safety profile within the tested doses range of CM-101 - maximum tolerated dose (MTD)
10 weeks
Level of antibodies
10 weeks
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Anti-human CCL24 monoclonal antibody (CM-101)EXPERIMENTALSingle 5 mg/kg of CM-101, Subcutaneous administration
PlaceboPLACEBO_COMPARATORPlacebo : Subcutaneous administration

Interventions

NameTypeDescription
CM-101DRUGAnti-human CCL24 monoclonal antibody (CM-101)
PlaceboDRUGPlacebo Comparator
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Eligibility Criteria

Age Range18 Years to 45 Years
SexMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: 1. Subjects must provide written informed consent prior to participating in the study. 2. Considered healthy by the Investigator as defined by no clinically relevant abnormalities identified by a detailed medical history, full physical examination, 12-lead ECG, and clinical labo...

Countries:Israel
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Frequently asked questions about CM-101

What is CM-101 used for?

CM-101 is an investigational small molecule being developed for Nonalcoholic Steatohepatitis (NASH). It is also being studied for medical conditions involving inflammatory and fibrotic mechanisms, including Primary Sclerosing Cholangitis (PSC) and Systemic Sclerosis (SSc).

Who makes CM-101?

CM-101 is being developed by Chemomab Therapeutics Ltd., a biopharmaceutical company. The company's stock is traded under the ticker symbol CMMB.

What phase is CM-101 in?

CM-101 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. A Phase 1 trial has been completed, and the drug remains in early-stage clinical testing.

What clinical trials is CM-101 in?

CM-101 has one completed Phase 1 clinical trial, identified as NCT06037577. This trial evaluated subcutaneous doses of CM-101 in healthy male subjects for conditions involving inflammatory and fibrotic mechanisms, including NASH, PSC, and SSc.

Is CM-101 the same as any other drug?

CM-101 is the sole name provided for this investigational drug. No alternative names have been reported for this asset.