xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06025851</url>
    </required_header>
    <id_info>
      <org_study_id>CM-101-I-001</org_study_id>
      <nct_id>NCT06025851</nct_id>
    </id_info>
    <brief_title>Intravenous Doses of CM-101 as a Treatment for Medical Conditions Involving Inflammatory and Fibrotic Mechanisms in Healthy Male Subjects</brief_title>
    <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</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>ChemomAb Ltd.</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>ChemomAb Ltd.</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        The study is designed to investigate the safety and tolerability of CM-101 for the treatment&#xD;
        of medical conditions involving inflammatory and fibrotic mechanisms such as non-alcoholic&#xD;
        steatohepatitis (NASH) and primary sclerosing cholangitis (PSC) and systemic sclerosis (SSc).&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        A total of 32 male subjects were enrolled into the study and randomized to 4 treatment&#xD;
        groups. The study was comprised of a screening period, a treatment day, a follow-up (FU)&#xD;
        period of 42 days and an end of study (EOS) FU visit. In each Dose Group subjects was&#xD;
        randomized to receive a single IV infusion of CM-101.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">July 24, 2017</start_date>
    <completion_date type="Actual">February 18, 2018</completion_date>
    <primary_completion_date type="Actual">February 18, 2018</primary_completion_date>
    <phase>Phase 1</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Sequential Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Double (Participant, Investigator)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Incidence and characteristics of adverse events (AEs) occurring following single doses of CM 101.</measure>
      <time_frame>1 day single-dose administration over 10 weeks</time_frame>
      <description>Incidence and characteristics of adverse events (AEs) occurring following single doses of CM 101.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Plasma Pharmacokinetic (PK) parameters of CM-101 - Maximum CM-101 plasma concentration (Cmax)</measure>
      <time_frame>1 day single-dose administration over 10 weeks</time_frame>
      <description>Observed maximum plasma concentration</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Plasma Pharmacokinetic (PK) parameters of CM-101 - Time to Cmax (tmax)</measure>
      <time_frame>1 day single-dose administration over 10 weeks</time_frame>
      <description>Time to reach the observed maximum plasma concentration (Tmax)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>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</measure>
      <time_frame>1 day single-dose administration over 10 week</time_frame>
      <description>Area under the curve (AUC) to the final concentration ≥ limit of quantitation (LOQ), AUC(0-t) and to infinity AUCinf</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Plasma Pharmacokinetic (PK) parameters of CM-101 - Terminal elimination rate constant (λz)</measure>
      <time_frame>1 day single-dose administration over 10 week</time_frame>
      <description>Elimination rate constant, determined by linear regression of the terminal points of the ln-linear plasma concentration-time curve</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Plasma Pharmacokinetic (PK) parameters of CM-101 - Terminal elimination half-life (T½)</measure>
      <time_frame>1 day single-dose administration over 10 week</time_frame>
      <description>Terminal elimination half-life, defined as 0.693/λz</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Assessment, based on the safety profile</measure>
      <time_frame>1 day single-dose administration over 10 week</time_frame>
      <description>Assessment, based on the safety profile, whether dose-limiting toxicity (DLT) and MTD are attained within the tested doses range of CM-101.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Level of antibodies against CM-101</measure>
      <time_frame>1 day single-dose administration over 10 week</time_frame>
      <description>Immunogenicity as expressed by formation anti drug antibodies (ADA)</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">32</enrollment>
    <condition>Healthy</condition>
    <arm_group>
      <arm_group_label>Anti-human CCL24 monoclonal antibody (CM-101)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>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)</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Placebo</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>Placebo - intravenous infusion</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Anti-human CCL24 monoclonal antibody (CM-101)</intervention_name>
      <description>Intravenous Infusion of Anti-human CCL24 monoclonal antibody (CM-101)</description>
      <arm_group_label>Anti-human CCL24 monoclonal antibody (CM-101)</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Placebo</intervention_name>
      <description>Placebo Comparator</description>
      <arm_group_label>Placebo</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria&#xD;
  &#xD;
            1. Subjects must provide written informed consent prior to participating in the study.&#xD;
  &#xD;
            2. Considered healthy by the Investigator as defined by no clinically relevant&#xD;
               abnormalities identified by a detailed medical history, full physical examination,&#xD;
               12-lead ECG and clinical laboratory tests.&#xD;
  &#xD;
            3. Body Mass Index (BMI) 19.0-29.0 kg/m2 and total body weight within 55-95 Kg.&#xD;
  &#xD;
            4. Fertile men must agree to use a barrier contraceptive (condom) for 90 days post-dosing&#xD;
               and are restricted from donating sperm for 90 days after dosing. Subjects with a&#xD;
               vasectomy performed more than 6 months prior to treatment are also acceptable.&#xD;
  &#xD;
            5. Non-smoking and no use of any tobacco or nicotine product by declaration for a period&#xD;
               for at least 3 month prior to screening period.&#xD;
  &#xD;
            6. Supine blood pressure and heart rate within normal limits (systolic 90-140 mmHg;&#xD;
               diastolic 50-90 mmHg, heart rate 45-100 beats per minute). No evidence of orthostatic&#xD;
               hypotension.&#xD;
  &#xD;
            7. ECG with no clinically significant abnormalities recorded at Screening visit and on&#xD;
               dosing day (before drug administration): PR interval within 120 and 210 ms, QRS&#xD;
               interval &lt; 120 ms, and QTc interval &lt;450 ms.&#xD;
  &#xD;
            8. Subjects who are willing and able to comply with scheduled visits, treatment plan,&#xD;
               laboratory tests, and other study procedures.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Evidence or history of clinically relevant hematological, renal, endocrine, pulmonary,&#xD;
               gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic&#xD;
               disease (including drug allergies,). This includes any acute or chronic medical or&#xD;
               psychiatric condition or laboratory abnormality that may increase the risk associated&#xD;
               with study participation or CM-101 administration or may interfere with the&#xD;
               interpretation of study results and, in the judgment of the Investigator, would make&#xD;
               the subject inappropriate for entry into this study.&#xD;
  &#xD;
            2. History or current drug/alcohol abuse. History of regular alcohol consumption&#xD;
               exceeding - 14 drinks/week for men (1 drink = 5 ounces [150 mL] of wine or 12 ounces&#xD;
               [360 mL] of beer or 1.5 ounces [45 mL] of hard liquor) within 6 months of screening.&#xD;
  &#xD;
            3. Hypereosinophilia defined as peripheral blood Eosinophils &gt; 4.5×108/L (450/μl) or&#xD;
               exceeding 7% of the circulating leukocytes.&#xD;
  &#xD;
            4. Positive urine drug of abuse (DoA) in screening and on admission.&#xD;
  &#xD;
            5. Positive breath alcohol test on admission.&#xD;
  &#xD;
            6. Known acute or chronic allergy to any drug or hypersensitivity to any of the test&#xD;
               compounds or contraindication to test product.&#xD;
  &#xD;
            7. Use of any prescription or over-the-counter (OTC) medications, including vitamins and&#xD;
               herbal or dietary supplements within 14 days prior to dosing. Paracetamol for&#xD;
               symptomatic relief of pain is allowed until 24 hours prior to the study drug&#xD;
               administration.&#xD;
  &#xD;
            8. Having received any biological treatment with recombinant antibodies, immunological&#xD;
               therapy, or anticancer treatment. Previous standard vaccination treatment is allowed.&#xD;
  &#xD;
            9. Positive HIV, hepatitis HBsAg or hepatitis HCV Ab serology tests at Screening.&#xD;
  &#xD;
           10. Subjects who donated blood in the 3 months or received blood or plasma derivatives in&#xD;
               the 6 months preceding study drug administration.&#xD;
  &#xD;
           11. Participation in another clinical trial within 3 months prior to dosing (calculated&#xD;
               from the previous study's last dosing day).&#xD;
  &#xD;
           12. Subjects with any acute medical situation (e.g. acute infection) within 48 hours of&#xD;
               dosing, which is considered of significance by the Principal Investigator&#xD;
  &#xD;
           13. Subjects with an inability to communicate well with the investigators and CRC staff&#xD;
               (e.g., language problem, poor mental development).&#xD;
        </textblock>
      </criteria>
      <gender>Male</gender>
      <gender_based>Yes</gender_based>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>45 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Jacob Atsmon, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Tel-Aviv Sourasky Medical Center</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Tel Aviv Sourasky Medical Center</name>
        <address>
          <city>Tel Aviv</city>
          <country>Israel</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Israel</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 30, 2023</study_first_submitted>
    <study_first_submitted_qc>August 30, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 6, 2023</study_first_posted>
    <last_update_submitted>September 7, 2023</last_update_submitted>
    <last_update_submitted_qc>September 7, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 11, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Antibodies</mesh_term>
      <mesh_term>Antibodies, Monoclonal</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06025851
  org study id: CM-101-I-001
  nct id: NCT06025851
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  is us export: No
  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).
  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.
  allocation: Randomized
  intervention model: Sequential Assignment
  primary purpose: Treatment
  masking: Double (Participant, Investigator)
  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
  description: Incidence and characteristics of adverse events (AEs) occurring following single doses of CM 101.
  measure: Plasma Pharmacokinetic (PK) parameters of CM-101 - Maximum CM-101 plasma concentration (Cmax)
  time frame: 1 day single-dose administration over 10 weeks
  description: Observed maximum plasma concentration
  measure: Plasma Pharmacokinetic (PK) parameters of CM-101 - Time to Cmax (tmax)
  time frame: 1 day single-dose administration over 10 weeks
  description: Time to reach the observed maximum plasma concentration (Tmax)
  measure: 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
  description: Area under the curve (AUC) to the final concentration ≥ limit of quantitation (LOQ), AUC(0-t) and to infinity AUCinf
  measure: Plasma Pharmacokinetic (PK) parameters of CM-101 - Terminal elimination rate constant (λz)
  time frame: 1 day single-dose administration over 10 week
  description: Elimination rate constant, determined by linear regression of the terminal points of the ln-linear plasma concentration-time curve
  measure: Plasma Pharmacokinetic (PK) parameters of CM-101 - Terminal elimination half-life (T½)
  time frame: 1 day single-dose administration over 10 week
  description: Terminal elimination half-life, defined as 0.693/λz
  measure: Assessment, based on the safety profile
  time frame: 1 day single-dose administration over 10 week
  description: Assessment, based on the safety profile, whether dose-limiting toxicity (DLT) and MTD are attained within the tested doses range of CM-101.
  measure: Level of antibodies against CM-101
  time frame: 1 day single-dose administration over 10 week
  description: Immunogenicity as expressed by formation anti drug antibodies (ADA)
  arm group label: Anti-human CCL24 monoclonal antibody (CM-101)
  arm group type: Experimental
  description: 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)
  arm group label: Placebo
  arm group type: Placebo Comparator
  description: Placebo - intravenous infusion
  intervention type: Drug
  intervention name: Anti-human CCL24 monoclonal antibody (CM-101)
  description: Intravenous Infusion of Anti-human CCL24 monoclonal antibody (CM-101)
  arm group label: Anti-human CCL24 monoclonal antibody (CM-101)
  intervention type: Drug
  intervention name: Placebo
  description: Placebo Comparator
  arm group label: Placebo
  criteria: 
  gender: Male
  gender based: Yes
  minimum age: 18 Years
  maximum age: 45 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Jacob Atsmon, MD
  role: Principal Investigator
  affiliation: Tel-Aviv Sourasky Medical Center
  facility: 
  country: Israel
  responsible party type: Sponsor
  mesh term: Antibodies
  mesh term: Antibodies, Monoclonal
  sharing ipd: No