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/NCT06037577</url>
    </required_header>
    <id_info>
      <org_study_id>CM-101-SC-001</org_study_id>
      <nct_id>NCT06037577</nct_id>
    </id_info>
    <brief_title>Subcutaneous 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 Subcutaneous 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>
    </oversight_info>
    <brief_summary>
      <textblock>
        CM-101 is developed as treatment for medical conditions involving inflammatory and fibrotic&#xD;
        mechanisms such as non-alcoholic steatohepatitis (NASH) and primary sclerosing cholangitis&#xD;
        (PSC) and systemic sclerosis (SSc). In this current study, the IP is tested in healthy male&#xD;
        volunteers.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        A single-center, randomized double-blind, placebo-controlled, single-dose study Healthy&#xD;
        volunteers were screened for up to 28 days prior to drug administration. The study included&#xD;
        one dose group of 8 subjects. A single 5 mg/kg CM-101 dose was subcutaneously administered.&#xD;
        The study was comprised of a screening period, a treatment day, a follow-up (FU) period of 42&#xD;
        days and an end of study (EOS) FU visit.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">March 5, 2019</start_date>
    <completion_date type="Actual">May 5, 2019</completion_date>
    <primary_completion_date type="Actual">May 5, 2019</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>Parallel 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)</measure>
      <time_frame>10 weeks</time_frame>
      <description>Incidence and characteristics of adverse events (AEs) occurring following single subcutaneous doses of CM-101</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Plasma pharmacokinetic (PK) of CM-101 - Maximum CM-101 plasma concentration (Cmax)</measure>
      <time_frame>10 weeks</time_frame>
      <description>Maximum CM-101 plasma concentration (Cmax)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Plasma pharmacokinetic (PK) of CM-101 - Time to Cmax (tmax)</measure>
      <time_frame>10 weeks</time_frame>
      <description>Time to Cmax (tmax)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>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</measure>
      <time_frame>10 weeks</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) of CM-101 - Terminal elimination rate constant (λz)</measure>
      <time_frame>10 weeks</time_frame>
      <description>Terminal elimination rate constant (λz)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Plasma pharmacokinetic (PK) of CM-101 - Terminal elimination half-life (T½)</measure>
      <time_frame>10 weeks</time_frame>
      <description>Terminal elimination half-life (T½)</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Assessment, based on the safety profile within the tested doses range of CM-101 - dose-limiting toxicity (DLT)</measure>
      <time_frame>10 weeks</time_frame>
      <description>Assessment, based on the safety profile, whether dose-limiting toxicity (DLT) is attained within the tested doses range of CM-101</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Assessment, based on the safety profile within the tested doses range of CM-101 - maximum tolerated dose (MTD)</measure>
      <time_frame>10 weeks</time_frame>
      <description>Assessment, based on the safety profile, whether maximum tolerated dose (MTD) is attained within the tested doses range of CM-101</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Level of antibodies</measure>
      <time_frame>10 weeks</time_frame>
      <description>Level of antibodies against CM-101</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">8</enrollment>
    <condition>Nonalcoholic Steatohepatitis (NASH)</condition>
    <condition>Primary Sclerosing Cholangitis (PSC)</condition>
    <condition>Systemic Sclerosis (SSc)</condition>
    <arm_group>
      <arm_group_label>Anti-human CCL24 monoclonal antibody (CM-101)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Single 5 mg/kg of CM-101, Subcutaneous administration</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Placebo</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>Placebo : Subcutaneous administration</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>CM-101</intervention_name>
      <description>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;
               of at least 3 months prior to screening.&#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.&#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 drugs of abuse (DoA) test during 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;
               formulation compounds or contraindication to the 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 up to 24 hours prior to 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.&#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>
      <gender_description>Healthy Male Subjects</gender_description>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>45 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Arnon Aharon, MD</last_name>
      <role>Study Director</role>
      <affiliation>ChemomAb Ltd.</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Tel Aviv Sourasky Medical Center</name>
        <address>
          <city>Tel Aviv</city>
          <zip>6423916</zip>
          <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>September 7, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 14, 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 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Fatty Liver</mesh_term>
      <mesh_term>Cholangitis</mesh_term>
      <mesh_term>Non-alcoholic Fatty Liver Disease</mesh_term>
      <mesh_term>Cholangitis, Sclerosing</mesh_term>
      <mesh_term>Scleroderma, Systemic</mesh_term>
      <mesh_term>Scleroderma, Diffuse</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Streptococcal polysaccharide type III group B</mesh_term>
    </intervention_browse>
    <!-- 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/NCT06037577
  org study id: CM-101-SC-001
  nct id: NCT06037577
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  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.
  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.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Double (Participant, Investigator)
  measure: Incidence and characteristics of adverse events (AEs)
  time frame: 10 weeks
  description: Incidence and characteristics of adverse events (AEs) occurring following single subcutaneous doses of CM-101
  measure: Plasma pharmacokinetic (PK) of CM-101 - Maximum CM-101 plasma concentration (Cmax)
  time frame: 10 weeks
  description: Maximum CM-101 plasma concentration (Cmax)
  measure: Plasma pharmacokinetic (PK) of CM-101 - Time to Cmax (tmax)
  time frame: 10 weeks
  description: Time to Cmax (tmax)
  measure: 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
  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) of CM-101 - Terminal elimination rate constant (λz)
  time frame: 10 weeks
  description: Terminal elimination rate constant (λz)
  measure: Plasma pharmacokinetic (PK) of CM-101 - Terminal elimination half-life (T½)
  time frame: 10 weeks
  description: Terminal elimination half-life (T½)
  measure: Assessment, based on the safety profile within the tested doses range of CM-101 - dose-limiting toxicity (DLT)
  time frame: 10 weeks
  description: Assessment, based on the safety profile, whether dose-limiting toxicity (DLT) is attained within the tested doses range of CM-101
  measure: Assessment, based on the safety profile within the tested doses range of CM-101 - maximum tolerated dose (MTD)
  time frame: 10 weeks
  description: Assessment, based on the safety profile, whether maximum tolerated dose (MTD) is attained within the tested doses range of CM-101
  measure: Level of antibodies
  time frame: 10 weeks
  description: Level of antibodies against CM-101
  arm group label: Anti-human CCL24 monoclonal antibody (CM-101)
  arm group type: Experimental
  description: Single 5 mg/kg of CM-101, Subcutaneous administration
  arm group label: Placebo
  arm group type: Placebo Comparator
  description: Placebo : Subcutaneous administration
  intervention type: Drug
  intervention name: CM-101
  description: 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
  gender description: Healthy Male Subjects
  minimum age: 18 Years
  maximum age: 45 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Arnon Aharon, MD
  role: Study Director
  affiliation: ChemomAb Ltd.
  facility: 
  country: Israel
  responsible party type: Sponsor
  mesh term: Fatty Liver
  mesh term: Cholangitis
  mesh term: Non-alcoholic Fatty Liver Disease
  mesh term: Cholangitis, Sclerosing
  mesh term: Scleroderma, Systemic
  mesh term: Scleroderma, Diffuse
  mesh term: Streptococcal polysaccharide type III group B