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

Primary Purpose

Nonalcoholic Steatohepatitis (NASH), Primary Sclerosing Cholangitis (PSC), Systemic Sclerosis (SSc)

Status
Completed
Phase
Phase 1
Locations
Israel
Study Type
Interventional
Intervention
CM-101
Placebo
Sponsored by
ChemomAb Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nonalcoholic Steatohepatitis (NASH)

Eligibility Criteria

18 Years - 45 Years (Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria: Subjects must provide written informed consent prior to participating in the study. 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 laboratory tests. Body Mass Index (BMI) 19.0-29.0 kg/m2 and total body weight within 55-95 Kg. Fertile men must agree to use a barrier contraceptive (condom) for 90 days post-dosing and are restricted from donating sperm for 90 days after dosing. Subjects with a vasectomy performed more than 6 months prior to treatment are also acceptable. Non-smoking and no use of any tobacco or nicotine product by declaration for a period of at least 3 months prior to screening. Supine blood pressure and heart rate within normal limits (systolic 90-140 mmHg; diastolic 50-90 mmHg, heart rate 45-100 beats per minute). No evidence of orthostatic hypotension. ECG with no clinically significant abnormalities recorded at Screening visit and on dosing day (before drug administration): PR interval within 120 and 210 ms, QRS interval< 120 ms, and QTc interval <450 ms. Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures. Exclusion Criteria: 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. 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. Hypereosinophilia defined as peripheral blood Eosinophils > 4.5×108/L (450/μl) or exceeding 7% of the circulating leukocytes. Positive urine drugs of abuse (DoA) test during screening and on admission. Positive breath alcohol test on admission. Known acute or chronic allergy to any drug or hypersensitivity to any of the test formulation compounds or contraindication to the test product. 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 up to 24 hours prior to study drug administration. Having received any biological treatment with recombinant antibodies, immunological therapy, or anticancer treatment. Previous standard vaccination treatment is allowed. Positive HIV, hepatitis HBsAg or hepatitis HCV Ab serology tests at Screening. Subjects who donated blood in the 3 months or received blood or plasma derivatives in the 6 months preceding study drug administration. Participation in another clinical trial within 3 months prior to dosing (calculated from the previous study's last dosing day). Subjects with any acute medical situation (e.g. acute infection) within 48 hours of dosing. Subjects with an inability to communicate well with the investigators and CRC staff (e.g., language problem, poor mental development).

Sites / Locations

  • Tel Aviv Sourasky Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Anti-human CCL24 monoclonal antibody (CM-101)

Placebo

Arm Description

Single 5 mg/kg of CM-101, Subcutaneous administration

Placebo : Subcutaneous administration

Outcomes

Primary Outcome Measures

Incidence and characteristics of adverse events (AEs)
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)
Maximum CM-101 plasma concentration (Cmax)
Plasma pharmacokinetic (PK) of CM-101 - Time to Cmax (tmax)
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
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)
Terminal elimination rate constant (λz)
Plasma pharmacokinetic (PK) of CM-101 - Terminal elimination half-life (T½)
Terminal elimination half-life (T½)

Secondary Outcome Measures

Assessment, based on the safety profile within the tested doses range of CM-101 - dose-limiting toxicity (DLT)
Assessment, based on the safety profile, whether dose-limiting toxicity (DLT) is attained within the tested doses range of CM-101
Assessment, based on the safety profile within the tested doses range of CM-101 - maximum tolerated dose (MTD)
Assessment, based on the safety profile, whether maximum tolerated dose (MTD) is attained within the tested doses range of CM-101
Level of antibodies
Level of antibodies against CM-101

Full Information

First Posted
August 30, 2023
Last Updated
September 7, 2023
Sponsor
ChemomAb Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT06037577
Brief Title
Subcutaneous Doses of CM-101 as a Treatment for Medical Conditions Involving Inflammatory and Fibrotic Mechanisms in Healthy Male Subjects
Official Title
A Double-Blind, Randomized, Placebo-Controlled, Phase I Study To Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Escalating Subcutaneous Doses of CM-101 in Healthy Male Subjects
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
March 5, 2019 (Actual)
Primary Completion Date
May 5, 2019 (Actual)
Study Completion Date
May 5, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ChemomAb Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
CM-101 is developed as treatment for medical conditions involving inflammatory and fibrotic mechanisms such as non-alcoholic steatohepatitis (NASH) and primary sclerosing cholangitis (PSC) and systemic sclerosis (SSc). In this current study, the IP is tested in healthy male volunteers.
Detailed Description
A single-center, randomized double-blind, placebo-controlled, single-dose study Healthy volunteers were screened for up to 28 days prior to drug administration. The study included one dose group of 8 subjects. A single 5 mg/kg CM-101 dose was subcutaneously administered. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nonalcoholic Steatohepatitis (NASH), Primary Sclerosing Cholangitis (PSC), Systemic Sclerosis (SSc)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
8 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Anti-human CCL24 monoclonal antibody (CM-101)
Arm Type
Experimental
Arm Description
Single 5 mg/kg of CM-101, Subcutaneous administration
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo : Subcutaneous administration
Intervention Type
Drug
Intervention Name(s)
CM-101
Intervention Description
Anti-human CCL24 monoclonal antibody (CM-101)
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo Comparator
Primary Outcome Measure Information:
Title
Incidence and characteristics of adverse events (AEs)
Description
Incidence and characteristics of adverse events (AEs) occurring following single subcutaneous doses of CM-101
Time Frame
10 weeks
Title
Plasma pharmacokinetic (PK) of CM-101 - Maximum CM-101 plasma concentration (Cmax)
Description
Maximum CM-101 plasma concentration (Cmax)
Time Frame
10 weeks
Title
Plasma pharmacokinetic (PK) of CM-101 - Time to Cmax (tmax)
Description
Time to Cmax (tmax)
Time Frame
10 weeks
Title
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
Description
Area under the curve (AUC) to the final concentration ≥ limit of quantitation (LOQ), AUC(0-t) and to infinity AUCinf
Time Frame
10 weeks
Title
Plasma pharmacokinetic (PK) of CM-101 - Terminal elimination rate constant (λz)
Description
Terminal elimination rate constant (λz)
Time Frame
10 weeks
Title
Plasma pharmacokinetic (PK) of CM-101 - Terminal elimination half-life (T½)
Description
Terminal elimination half-life (T½)
Time Frame
10 weeks
Secondary Outcome Measure Information:
Title
Assessment, based on the safety profile within the tested doses range of CM-101 - dose-limiting toxicity (DLT)
Description
Assessment, based on the safety profile, whether dose-limiting toxicity (DLT) is attained within the tested doses range of CM-101
Time Frame
10 weeks
Title
Assessment, based on the safety profile within the tested doses range of CM-101 - maximum tolerated dose (MTD)
Description
Assessment, based on the safety profile, whether maximum tolerated dose (MTD) is attained within the tested doses range of CM-101
Time Frame
10 weeks
Title
Level of antibodies
Description
Level of antibodies against CM-101
Time Frame
10 weeks

10. Eligibility

Sex
Male
Gender Based
Yes
Gender Eligibility Description
Healthy Male Subjects
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Subjects must provide written informed consent prior to participating in the study. 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 laboratory tests. Body Mass Index (BMI) 19.0-29.0 kg/m2 and total body weight within 55-95 Kg. Fertile men must agree to use a barrier contraceptive (condom) for 90 days post-dosing and are restricted from donating sperm for 90 days after dosing. Subjects with a vasectomy performed more than 6 months prior to treatment are also acceptable. Non-smoking and no use of any tobacco or nicotine product by declaration for a period of at least 3 months prior to screening. Supine blood pressure and heart rate within normal limits (systolic 90-140 mmHg; diastolic 50-90 mmHg, heart rate 45-100 beats per minute). No evidence of orthostatic hypotension. ECG with no clinically significant abnormalities recorded at Screening visit and on dosing day (before drug administration): PR interval within 120 and 210 ms, QRS interval< 120 ms, and QTc interval <450 ms. Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures. Exclusion Criteria: 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. 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. Hypereosinophilia defined as peripheral blood Eosinophils > 4.5×108/L (450/μl) or exceeding 7% of the circulating leukocytes. Positive urine drugs of abuse (DoA) test during screening and on admission. Positive breath alcohol test on admission. Known acute or chronic allergy to any drug or hypersensitivity to any of the test formulation compounds or contraindication to the test product. 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 up to 24 hours prior to study drug administration. Having received any biological treatment with recombinant antibodies, immunological therapy, or anticancer treatment. Previous standard vaccination treatment is allowed. Positive HIV, hepatitis HBsAg or hepatitis HCV Ab serology tests at Screening. Subjects who donated blood in the 3 months or received blood or plasma derivatives in the 6 months preceding study drug administration. Participation in another clinical trial within 3 months prior to dosing (calculated from the previous study's last dosing day). Subjects with any acute medical situation (e.g. acute infection) within 48 hours of dosing. Subjects with an inability to communicate well with the investigators and CRC staff (e.g., language problem, poor mental development).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arnon Aharon, MD
Organizational Affiliation
ChemomAb Ltd.
Official's Role
Study Director
Facility Information:
Facility Name
Tel Aviv Sourasky Medical Center
City
Tel Aviv
ZIP/Postal Code
6423916
Country
Israel

12. IPD Sharing Statement

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

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