Intravenous Doses of CM-101 as a Treatment for Medical Conditions Involving Inflammatory and Fibrotic Mechanisms in Healthy Male Subjects

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Placebo; Drug: Anti-human CCL24 monoclonal antibody (CM-101)

• Registration Number: NCT06025851
• Lead Sponsor: ChemomAb Ltd.

Brief Summary

The study is designed to investigate the safety and tolerability of CM-101 for the treatment of medical conditions involving inflammatory and fibrotic mechanisms such as non-alcoholic steatohepatitis (NASH) and primary sclerosing cholangitis (PSC) and systemic sclerosis (SSc).

Detailed Description

A total of 32 male subjects were enrolled into the study and randomized to 4 treatment groups. The study was comprised of a screening period, a treatment day, a follow-up (FU) period of 42 days and an end of study (EOS) FU visit. In each Dose Group subjects was randomized to receive a single IV infusion of CM-101.

Study Timeline

• Study Start: 2017-07-24
• Primary Completion: 2018-02-18
• Study Completion: 2018-02-18
• Study First Submitted: 2023-08-30
• Study First Submitted QC: 2023-08-30
• Status Verified: 2023-09
• Study First Posted: 2023-09-06
• Last Update Submitted: 2023-09-07
• Last Update Posted: 2023-09-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 32

Inclusion Criteria

Not provided

Exclusion Criteria

1. Evidence or history of clinically relevant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies,). This includes any acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or CM-101 administration or may interfere with the interpretation of study results and, in the judgment of the Investigator, would make the subject inappropriate for entry into this study.
2. History or current drug/alcohol abuse. History of regular alcohol consumption exceeding - 14 drinks/week for men (1 drink = 5 ounces [150 mL] of wine or 12 ounces [360 mL] of beer or 1.5 ounces [45 mL] of hard liquor) within 6 months of screening.
3. Hypereosinophilia defined as peripheral blood Eosinophils > 4.5×108/L (450/μl) or exceeding 7% of the circulating leukocytes.
4. Positive urine drug of abuse (DoA) in screening and on admission.
5. Positive breath alcohol test on admission.
6. Known acute or chronic allergy to any drug or hypersensitivity to any of the test compounds or contraindication to test product.
7. Use of any prescription or over-the-counter (OTC) medications, including vitamins and herbal or dietary supplements within 14 days prior to dosing. Paracetamol for symptomatic relief of pain is allowed until 24 hours prior to the study drug administration.
8. Having received any biological treatment with recombinant antibodies, immunological therapy, or anticancer treatment. Previous standard vaccination treatment is allowed.
9. Positive HIV, hepatitis HBsAg or hepatitis HCV Ab serology tests at Screening.
10. Subjects who donated blood in the 3 months or received blood or plasma derivatives in the 6 months preceding study drug administration.
11. Participation in another clinical trial within 3 months prior to dosing (calculated from the previous study's last dosing day).
12. Subjects with any acute medical situation (e.g. acute infection) within 48 hours of dosing, which is considered of significance by the Principal Investigator
13. Subjects with an inability to communicate well with the investigators and CRC staff (e.g., language problem, poor mental development).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo - intravenous infusion
Anti-human CCL24 monoclonal antibody (CM-101)	Anti-human CCL24 monoclonal antibody (CM-101)	Anti-human CCL24 monoclonal antibody (CM-101) Four (4) treatment groups (0.75 mg/kg, 2.5 mg/kg, 5.0 mg/kg, 10 mg/kg)

Primary Outcome Measures

Name	Time	Method
Plasma Pharmacokinetic (PK) parameters of CM-101 - Maximum CM-101 plasma concentration (Cmax)	1 day single-dose administration over 10 weeks	Observed maximum plasma concentration
Plasma Pharmacokinetic (PK) parameters of CM-101 - Time to Cmax (tmax)	1 day single-dose administration over 10 weeks	Time to reach the observed maximum plasma concentration (Tmax)
Incidence and characteristics of adverse events (AEs) occurring following single doses of CM 101.	1 day single-dose administration over 10 weeks	Incidence and characteristics of adverse events (AEs) occurring following single doses of CM 101.
Plasma Pharmacokinetic (PK) parameters of CM-101 - Terminal elimination rate constant (λz)	1 day single-dose administration over 10 week	Elimination rate constant, determined by linear regression of the terminal points of the ln-linear plasma concentration-time curve
Plasma Pharmacokinetic (PK) parameters of CM-101 - Terminal elimination half-life (T½)	1 day single-dose administration over 10 week	Terminal elimination half-life, defined as 0.693/λz
Plasma Pharmacokinetic (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	1 day single-dose administration over 10 week	Area under the curve (AUC) to the final concentration ≥ limit of quantitation (LOQ), AUC(0-t) and to infinity AUCinf

Secondary Outcome Measures

Name	Time	Method
Level of antibodies against CM-101	1 day single-dose administration over 10 week	Immunogenicity as expressed by formation anti drug antibodies (ADA)
Assessment, based on the safety profile	1 day single-dose administration over 10 week	Assessment, based on the safety profile, whether dose-limiting toxicity (DLT) and MTD are attained within the tested doses range of CM-101.

Trial Locations

Locations (1)

Tel Aviv Sourasky Medical Center; 🇮🇱 Tel Aviv, Israel