HealthyPhase 1NCT06025851
Intravenous Doses of CM-101 as a Treatment for Medical Conditions Involving Inflammatory and Fibrotic Mechanisms in Healthy Male Subjects
A Phase 1 study testing Anti-human CCL24 monoclonal antibody (CM-101) in people with Healthy, run by ChemomAb Ltd. at 1 site in Israel.
Trial 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). 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
- Healthy
- What is being tested?
- Anti-human CCL24 monoclonal antibody (CM-101)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteIsrael
- Study dates
- 24 Jul 2017to 18 Feb 2018
- 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 for at least 3 month prior to screening period.
- 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 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.
- 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 drug of abuse (DoA) in 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 compounds or contraindication to 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 until 24 hours prior to the 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, which is considered of significance by the Principal Investigator
- 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 Intravenous Doses of CM-101 in Healthy Male Subjects
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).
Read the 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.
- Conditions
- Healthy
- Being tested
- Anti-human CCL24 monoclonal antibody (CM-101), Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anti-human CCL24 monoclonal antibody (CM-101)Drug
Intravenous Infusion of Anti-human CCL24 monoclonal antibody (CM-101)
PlaceboDrug
Placebo Comparator
| Study group | Role | What they receive |
|---|---|---|
| Anti-human CCL24 monoclonal antibody (CM-101) | Experimental | 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) Receives: Drug: Anti-human CCL24 monoclonal antibody (CM-101) |
| Placebo | Placebo comparator | Placebo - intravenous infusion 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) occurring following single doses of CM 101.
Incidence and characteristics of adverse events (AEs) occurring following single doses of CM 101.
Measured: 1 day single-dose administration over 10 weeks
Plasma Pharmacokinetic (PK) parameters of CM-101 - Maximum CM-101 plasma concentration (Cmax)
Observed maximum plasma concentration
Measured: 1 day single-dose administration over 10 weeks
Plasma Pharmacokinetic (PK) parameters of CM-101 - Time to Cmax (tmax)
Time to reach the observed maximum plasma concentration (Tmax)
Measured: 1 day single-dose administration over 10 weeks
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
Area under the curve (AUC) to the final concentration ≥ limit of quantitation (LOQ), AUC(0-t) and to infinity AUCinf
Measured: 1 day single-dose administration over 10 week
Plasma Pharmacokinetic (PK) parameters of CM-101 - Terminal elimination rate constant (λz)
Elimination rate constant, determined by linear regression of the terminal points of the ln-linear plasma concentration-time curve
Measured: 1 day single-dose administration over 10 week
Plasma Pharmacokinetic (PK) parameters of CM-101 - Terminal elimination half-life (T½)
Terminal elimination half-life, defined as 0.693/λz
Measured: 1 day single-dose administration over 10 week
Secondary outcomes (2)
Assessment, based on the safety profile
Assessment, based on the safety profile, whether dose-limiting toxicity (DLT) and MTD are attained within the tested doses range of CM-101.
Measured: 1 day single-dose administration over 10 week
Level of antibodies against CM-101
Immunogenicity as expressed by formation anti drug antibodies (ADA)
Measured: 1 day single-dose administration over 10 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2023
- Study start24 Jul 2017
- Primary completion18 Feb 2018
- Study completion18 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- ChemomAb Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jacob Atsmon, MD, Principal investigator, Tel-Aviv Sourasky Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06025851
- Sponsor's protocol ID
- CM-101-I-001
- Status last verified
- Sep 2023
- First submitted
- 30 Aug 2023
- Last updated
- 11 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 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 Intravenous Doses of CM-101 in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT06025851
- Acronym / sponsor ID
- CM-101-I-001
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- ChemomAb Ltd.Industry (pharma, biotech, devices)
- Study start
- 24 Jul 2017 (actual)
- Primary completion
- 18 Feb 2018 (actual)
- Study completion
- 18 Feb 2018 (actual)
- First posted
- 6 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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anti-human CCL24 monoclonal antibody (CM-101) | Experimental | Drug: 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) |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo - intravenous infusion |
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 for at least 3 month prior to screening period.
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 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.
- 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 drug of abuse (DoA) in 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 |
|---|---|---|
| Anti-human CCL24 monoclonal antibody (CM-101)Intravenous Infusion of Anti-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) occurring following single doses of CM 101.
Time frame: 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 - Maximum CM-101 plasma concentration (Cmax)
Time frame: 1 day single-dose administration over 10 weeks
Observed maximum plasma concentration
Plasma Pharmacokinetic (PK) parameters of CM-101 - Time to Cmax (tmax)
Time frame: 1 day single-dose administration over 10 weeks
Time to reach the observed maximum plasma concentration (Tmax)
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
Time frame: 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
Plasma Pharmacokinetic (PK) parameters of CM-101 - Terminal elimination rate constant (λz)
Time frame: 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)
Time frame: 1 day single-dose administration over 10 week
Terminal elimination half-life, defined as 0.693/λz
2 secondary outcomes
Assessment, based on the safety profile
Time frame: 1 day single-dose administration over 10 week
Level of antibodies against CM-101
Time frame: 1 day single-dose administration over 10 week
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 11 Sep 2023.
- Individual participant dataSharing planned: No
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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.
Jacob Atsmon, MD principal investigator
Tel-Aviv Sourasky Medical Center
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 Anti-human CCL24 monoclonal antibody (CM-101) in people with Healthy, 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 11 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) occurring following single doses of CM 101. (time frame: 1 day single-dose administration over 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 11 Sep 2023.