Nonalcoholic Steatohepatitis (NASH)Phase 1NCT06037577
Subcutaneous Doses of CM-101 as a Treatment for Medical Conditions Involving Inflammatory and Fibrotic Mechanisms in Healthy Male Subjects
A Phase 1 study testing CM-101 in people with Nonalcoholic Steatohepatitis (NASH) and Primary Sclerosing Cholangitis (PSC), run by ChemomAb Ltd. at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Nonalcoholic Steatohepatitis (NASH), Primary Sclerosing Cholangitis (PSC), Systemic Sclerosis (SSc)
- What is being tested?
- CM-101
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 8 participants
- Where
- 1 siteIsrael
- Study dates
- 5 Mar 2019to 5 May 2019
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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).
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Nonalcoholic Steatohepatitis (NASH), Primary Sclerosing Cholangitis (PSC), Systemic Sclerosis (SSc)
- Being tested
- CM-101, Placebo
- Medical subject headings
- Non-alcoholic Fatty Liver Disease, Cholangitis, Sclerosing, Scleroderma, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CM-101Drug
Anti-human CCL24 monoclonal antibody (CM-101)
PlaceboDrug
Placebo Comparator
| Study group | Role | What they receive |
|---|---|---|
| Anti-human CCL24 monoclonal antibody (CM-101) | Experimental | Single 5 mg/kg of CM-101, Subcutaneous administration Receives: Drug: CM-101 |
| Placebo | Placebo comparator | Placebo : Subcutaneous administration Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and characteristics of adverse events (AEs)
Incidence and characteristics of adverse events (AEs) occurring following single subcutaneous doses of CM-101
Measured: 10 weeks
Plasma pharmacokinetic (PK) of CM-101 - Maximum CM-101 plasma concentration (Cmax)
Maximum CM-101 plasma concentration (Cmax)
Measured: 10 weeks
Plasma pharmacokinetic (PK) of CM-101 - Time to Cmax (tmax)
Time to Cmax (tmax)
Measured: 10 weeks
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
Measured: 10 weeks
Plasma pharmacokinetic (PK) of CM-101 - Terminal elimination rate constant (λz)
Terminal elimination rate constant (λz)
Measured: 10 weeks
Plasma pharmacokinetic (PK) of CM-101 - Terminal elimination half-life (T½)
Terminal elimination half-life (T½)
Measured: 10 weeks
Secondary outcomes (3)
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
Measured: 10 weeks
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
Measured: 10 weeks
Level of antibodies
Level of antibodies against CM-101
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2023
- Study start5 Mar 2019
- Primary completion5 May 2019
- Study completion5 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nonalcoholic Steatohepatitis (NASH)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- ChemomAb Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Arnon Aharon, MD, Study director, ChemomAb Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06037577
- Sponsor's protocol ID
- CM-101-SC-001
- Status last verified
- Sep 2023
- First submitted
- 30 Aug 2023
- Last updated
- 14 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06037577
- Acronym / sponsor ID
- CM-101-SC-001
- Conditions
- Nonalcoholic Steatohepatitis (NASH), Primary Sclerosing Cholangitis (PSC), Systemic Sclerosis (SSc)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- ChemomAb Ltd.Industry (pharma, biotech, devices)
- Study start
- 5 Mar 2019 (actual)
- Primary completion
- 5 May 2019 (actual)
- Study completion
- 5 May 2019 (actual)
- First posted
- 14 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anti-human CCL24 monoclonal antibody (CM-101) | Experimental | Drug: CM-101Single 5 mg/kg of CM-101, Subcutaneous administration |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo : Subcutaneous administration |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CM-101Anti-human CCL24 monoclonal antibody (CM-101) | Drug | Anti-human CCL24 monoclonal antibody (CM-101) |
| PlaceboPlacebo Comparator | Drug | Placebo |
Primary outcome
Incidence and characteristics of adverse events (AEs)
Time frame: 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)
Time frame: 10 weeks
Maximum CM-101 plasma concentration (Cmax)
Plasma pharmacokinetic (PK) of CM-101 - Time to Cmax (tmax)
Time frame: 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
Time frame: 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)
Time frame: 10 weeks
Terminal elimination rate constant (λz)
Plasma pharmacokinetic (PK) of CM-101 - Terminal elimination half-life (T½)
Time frame: 10 weeks
Terminal elimination half-life (T½)
3 secondary outcomes
Assessment, based on the safety profile within the tested doses range of CM-101 - dose-limiting toxicity (DLT)
Time frame: 10 weeks
Assessment, based on the safety profile within the tested doses range of CM-101 - maximum tolerated dose (MTD)
Time frame: 10 weeks
Level of antibodies
Time frame: 10 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arnon Aharon, MD study director
ChemomAb Ltd.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CM-101 in people with Nonalcoholic Steatohepatitis (NASH) and Primary Sclerosing Cholangitis (PSC), run by ChemomAb Ltd. at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and characteristics of adverse events (AEs) (time frame: 10 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2023.