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/NCT06005441</url>
    </required_header>
    <id_info>
      <org_study_id>CBL-0205</org_study_id>
      <nct_id>NCT06005441</nct_id>
    </id_info>
    <brief_title>A Phase 2b Study to Evaluate the Efficacy and Safety of CBL-514 Injection for Reducing Subcutaneous Fat.</brief_title>
    <official_title>A Phase 2b, Randomized, Placebo-Controlled Factorial Study to Evaluate the Efficacy, Safety and Tolerability of CBL-514 Injection Compared With CBL-A1 and CBL-A2 for Reducing Abdominal Subcutaneous Fat</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Caliway Biopharmaceuticals Co., Ltd.</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Caliway Biopharmaceuticals Co., Ltd.</source>
    <oversight_info>
      <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        This is a randomized, placebo-controlled, Phase 2b study to evaluate the efficacy, safety,&#xD;
        and tolerability of CBL-514 injection compared with CBL-A1 and CBL-A2 for reducing&#xD;
        subcutaneous fat.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        A total of approximately 160 adult participants with moderate or severe abdominal fat at&#xD;
        Screening will be enrolled. Each participant will receive up to 4 treatments of allocated&#xD;
        study drug administered subcutaneously to the abdomen, once every 3 weeks.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">December 2023</start_date>
    <completion_date type="Anticipated">July 2024</completion_date>
    <primary_completion_date type="Anticipated">July 2024</primary_completion_date>
    <phase>Phase 2</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, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Percentage of participants with at least 150 mL reduction in abdominal subcutaneous fat volume from Baseline to 8 weeks after the final treatment</measure>
      <time_frame>From Baseline to 8 weeks after the final treatment</time_frame>
      <description>Percentage of participants with at least 150 mL reduction in abdominal subcutaneous fat volume from Baseline to 8 weeks after the final treatment, as measured by MRI, of CBL-514 compared with CBL-A1, CBL-A2, and placebo.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Mean change in abdominal subcutaneous fat volume from Baseline to 4 weeks and 8 weeks post the final treatment</measure>
      <time_frame>From Baseline to 4 weeks and 8 weeks after the final treatment</time_frame>
      <description>Mean change in abdominal subcutaneous fat volume from Baseline to 4 weeks and 8 weeks post the final treatment, as measured by MRI, of CBL-514 compared with CBL-A1, CBL-A2, and placebo.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Percentage of participants with at least 150 mL reduction in abdominal subcutaneous fat volume from Baseline to 4 weeks after the final treatment</measure>
      <time_frame>From Baseline to 4 weeks after the final treatment</time_frame>
      <description>Percentage of participants with at least 150 mL reduction in abdominal subcutaneous fat volume from Baseline to 4 weeks after the final treatment, as measured by MRI, of CBL-514 compared with CBL-A1, CBL-A2, and placebo.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Percentage of participants with at least 200 mL reduction in abdominal subcutaneous fat volume from Baseline to 4 weeks and 8 weeks after the final treatment</measure>
      <time_frame>From Baseline to 4 weeks and 8 weeks after the final treatment</time_frame>
      <description>Percentage of participants with at least 200 mL reduction in abdominal subcutaneous fat volume from Baseline to 4 weeks and 8 weeks after the final treatment, as measured by MRI, of CBL-514 compared with CBL-A1, CBL-A2, and placebo.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Percentage of participants with at least 1-grade improvement reported by the Investigator using the Clinician-Reported Abdominal Fat Rating Scale (CR-AFRS) at 4 weeks and 8 weeks after the final treatment</measure>
      <time_frame>From Baseline to 4 weeks and 8 weeks after the final treatment</time_frame>
      <description>Percentage of participants with at least 1-grade improvement reported by the Investigator using the Clinician-Reported Abdominal Fat Rating Scale (CR-AFRS) at 4 weeks and 8 weeks after the final treatment, for CBL-514 compared with CBL-A1, CBL-A2, and placebo.&#xD;
  Note: The AFRS is a 5-point ordinal scale (0-5) to assess the abdominal fat level based on the presence of fat on abdomen with 1=None/Minimal, 2=Mild, 3=Moderate, 4=Severe and 5=Very Severe.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Percentage of participants with at least 1-grade improvement reported by the participant using the Patient-Reported Abdominal Fat Rating Scale (PR-AFRS) at 4 weeks and 8 weeks after the final treatment.</measure>
      <time_frame>From Baseline to 4 weeks and 8 weeks after the final treatment</time_frame>
      <description>Percentage of participants with at least 1-grade improvement reported by the participant using the Patient-Reported Abdominal Fat Rating Scale (PR-AFRS) at 4 weeks and 8 weeks after the final treatment, for CBL-514 compared with CBL-A1, CBL-A2, and placebo.&#xD;
  Note: The AFRS is a 5-point ordinal scale (0-5) to assess the abdominal fat level based on the presence of fat on abdomen with 1=None/Minimal, 2=Mild, 3=Moderate, 4=Severe and 5=Very Severe.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Percentage of participants with at least 1-grade improvement reported by the independent clinician using the Clinician-Reported Abdominal Fat Rating Scale (CR-AFRS) at 4 weeks and 8 weeks after the final treatment.</measure>
      <time_frame>From Baseline to 4 weeks and 8 weeks after the final treatment</time_frame>
      <description>Percentage of participants with at least 1-grade improvement reported by the independent clinician using the Clinician-Reported Abdominal Fat Rating Scale (CR-AFRS) at 4 weeks and 8 weeks after the final treatment, for CBL-514 compared with CBL-A1, CBL-A2, and placebo.&#xD;
  Note: The AFRS is a 5-point ordinal scale (0-5) to assess the abdominal fat level based on the presence of fat on abdomen with 1=None/Minimal, 2=Mild, 3=Moderate, 4=Severe and 5=Very Severe.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The incidence of treatment-emergent adverse events (TEAEs) as defined in the protocol</measure>
      <time_frame>From Baseline to 8 weeks after the final treatment</time_frame>
      <description>Number of participants experiencing TEAEs and number of individual TEAEs</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The incidence of clinically significant abnormal findings as defined in the protocol</measure>
      <time_frame>From Baseline to 8 weeks after the final treatment</time_frame>
      <description>Number of participants with clinically significant abnormalities in laboratory tests, vital signs and physical examinations</description>
    </secondary_outcome>
    <number_of_arms>4</number_of_arms>
    <enrollment type="Anticipated">160</enrollment>
    <condition>Subcutaneous Fat</condition>
    <arm_group>
      <arm_group_label>CBL-514 Injection</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participant will receive CBL-514 administered in 2.4 mL injections, up to 120 mL per treatment session at intervals of approximately 3 weeks for up to 4 treatments.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>CBL-A1 Injection</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participant will receive CBL-A1 administered in 2.4 mL injections, up to 120 mL per treatment session at intervals of approximately 3 weeks for up to 4 treatments.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>CBL-A2 Injection</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participant will receive CBL-A2 administered in 2.4 mL injections, up to 120 mL per treatment session at intervals of approximately 3 weeks for up to 4 treatments.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>0.9% Sodium Chloride</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>Participant will receive 0.9% Sodium Chloride administered in 2.4 mL injections, up to 120 mL per treatment session at intervals of approximately 3 weeks for up to 4 treatments.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>CBL-514 injection</intervention_name>
      <description>Provided as a ready for use injectable CBL-514 solution</description>
      <arm_group_label>CBL-514 Injection</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>CBL-A1 Injection</intervention_name>
      <description>Provided as a ready for use injectable CBL-A1 solution</description>
      <arm_group_label>CBL-A1 Injection</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>CBL-A2 Injection</intervention_name>
      <description>Provided as a ready for use injectable CBL-A2 solution</description>
      <arm_group_label>CBL-A2 Injection</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>0.9% Sodium Chloride</intervention_name>
      <description>Sodium Chloride (0.9% NaCl) placebo for injection</description>
      <arm_group_label>0.9% Sodium Chloride</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Male or female, aged 18 years to 64 years old (at Screening), inclusive.&#xD;
  &#xD;
            2. Body mass index (BMI) &gt;18.5 and &lt; 30 kg/m2 and body weight ≥ 50 kg at Screening and&#xD;
               Day 1.&#xD;
  &#xD;
            3. Participant has abdominal fat graded by the Investigator as Grade 3(moderate) or Grade&#xD;
               4(severe) using the Clinician-Reported Abdominal Fat Rating Scale via in-person&#xD;
               examination at Screening.&#xD;
  &#xD;
            4. Participant has stable body weight (identified as ≤ 3 kg weight change per participant&#xD;
               report) for at least 3 months before Screening and during the study.&#xD;
  &#xD;
            5. Voluntarily signs the Informed Consent Form and, in the opinion of the Investigator or&#xD;
               delegate, is physically and mentally capable of participating in the study and willing&#xD;
               to adhere to study procedures.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Female participant of childbearing potential who is not willing to commit to an&#xD;
               acceptable contraceptive regimen from the time of Screening and throughout study&#xD;
               participation until 90 days after the last IP dose, or who is currently pregnant or&#xD;
               lactating. Male participant who is not willing to commit to using a condom and&#xD;
               refraining from sperm donation from the time of the first dose of IP, throughout study&#xD;
               participation until 90 days after the last IP dose.&#xD;
  &#xD;
            2. Participant diagnosed with coagulation disorders or who is receiving&#xD;
               anticoagulant/antiplatelet therapy or medications or dietary supplements that impede&#xD;
               coagulation or platelet aggregation.&#xD;
  &#xD;
            3. Participant has hemoglobin A1c (HbA1c) ≥9%, delayed wound healing, or poorly&#xD;
               controlled diabetes defined as requiring a change in glucose control medications&#xD;
               (other than day to day variations in insulin requirements) within the 6 months prior&#xD;
               to Screening or for whom a change in glucose control medications is anticipated during&#xD;
               the study, or any diabetic risks that, in the opinion of Investigator, make the&#xD;
               individual an inappropriate candidate for the study.&#xD;
  &#xD;
            4. Participant with active or prior history of malignancies within 5 years before&#xD;
               Screening or currently being evaluated for a possible malignancy, with the exception&#xD;
               of adequately treated basal cell carcinoma of skin and in situ squamous cell carcinoma&#xD;
               of skin at Investigator's discretion.&#xD;
  &#xD;
            5. Participant with a history of human immunodeficiency virus (HIV)-1 infection or active&#xD;
               HIV infection at Screening with positive HIV antigen/antibody combo test.&#xD;
  &#xD;
            6. Participant with a history of trypanophobia, the extreme fear of medical procedures&#xD;
               involving injections or needles, or who experiences vasovagal syncope or faints at the&#xD;
               sight of blood or a needle.&#xD;
  &#xD;
            7. Participant with folding fat or skin on abdomen in standing position.&#xD;
  &#xD;
            8. Participant with abdominal visceral fat that causes supra-umbilicus fat to be more&#xD;
               bulging than infra-umbilicus fat.&#xD;
  &#xD;
            9. Participant with ventral abdominal or umbilical hernia or previous repair of same.&#xD;
  &#xD;
           10. Participant has abnormal skin or local skin conditions at the treatment area, which,&#xD;
               in the opinion of Investigator, would increase risk to the participant or inhibit&#xD;
               safety and efficacy evaluation, including but not limited to any of the following:&#xD;
  &#xD;
                 1. Skin manifestations of a systemic disease.&#xD;
  &#xD;
                 2. Any abnormality of the skin or soft tissues of the area to be treated, such as&#xD;
                    scars, striae, dyspigmentation, etc.&#xD;
  &#xD;
                 3. Asymmetrical fat on abdomen.&#xD;
  &#xD;
                 4. Lipomatosis syndromes (familial lipomatosis, nevus lipomatosis, Dercum's disease,&#xD;
                    etc).&#xD;
  &#xD;
                 5. Skin laxity on abdomen.&#xD;
  &#xD;
                 6. Sensory loss or dysesthesia in the area to be treated.&#xD;
  &#xD;
                 7. Tattoo(s) on the area to be treated.&#xD;
  &#xD;
           11. Participant who has undergone the following procedures:&#xD;
  &#xD;
                 1. Previous surgery that caused scar tissues on the anticipated treatment area&#xD;
                    before Screening or during the study, with the exception of laparoscopic surgery&#xD;
                    and surgery that resulted in minimal scar tissues determined at Investigator's&#xD;
                    discretion.&#xD;
  &#xD;
                 2. Liposuction or abdominoplasty to the region to be treated before Screening or&#xD;
                    during the study.&#xD;
  &#xD;
                 3. Aesthetic procedure for body contouring or fat reduction, e.g., cryolipolysis,&#xD;
                    ultrasonic lipolysis, low level laser therapy, EMSculpt, lipolysis injection to&#xD;
                    the region to be treated within 12 months before Screening or during the study.&#xD;
  &#xD;
                 4. Using medication that is delivered via subcutaneous injection at the treatment&#xD;
                    area within 4 weeks before Screening or during the study.&#xD;
  &#xD;
           12. Participant with contraindications to MRI imaging&#xD;
  &#xD;
           13. Participant is on prescription or OTC weight reduction medication, weight reduction&#xD;
               program, or any GLP-1 agonist (e.g., semaglutide, terzepatide, liraglutide, etc.)&#xD;
               (oral or injectable) within 6 months before Screening or during the study.&#xD;
  &#xD;
           14. Participant is undergoing chronic steroid or immunosuppressive therapy, with the&#xD;
               exception of oral steroid inhalation indicated for asthma management or topical&#xD;
               steroid application for skin conditions that are not directly applied or indirectly&#xD;
               affect the treatment area.&#xD;
  &#xD;
           15. Requiring continual use of any medication that is known to strongly inhibit or induce&#xD;
               CYP1A2 enzymes, sensitive CYP1A2 substrates or drugs with narrow therapeutic index&#xD;
               during the study that, in the opinion of the Investigator, may affect the evaluation&#xD;
               of the study product or place the participant at undue risk.&#xD;
  &#xD;
           16. Unable to receive local anesthesia.&#xD;
  &#xD;
           17. Participant with known allergies or sensitivities to the IP or its components.&#xD;
  &#xD;
           18. Participant with liver cirrhosis, with inadequate liver function at Screening defined&#xD;
               as aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline&#xD;
               phosphatase(ALP), total bilirubin (TBIL), or gamma-glutamyl transferase (GGT) &gt;3.0×&#xD;
               upper limit of normal (ULN), or with any hepatic medical condition that would&#xD;
               interfere with assessment of safety or efficacy.&#xD;
  &#xD;
           19. Participant with any renal impairment, defined as abnormal serum creatinine and blood&#xD;
               urea nitrogen (BUN) &gt;1.5× ULN or estimated glomerular filtration rate (eGFR)&#xD;
               &lt;90mL/min/1.73 m2, or who is currently on dialysis.&#xD;
  &#xD;
           20. Use of any investigational drug or device within 3 months prior to Screening.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>64 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Anne Sheu</last_name>
      <role>Study Director</role>
      <affiliation>Caliway Biopharmaceuticals Co., Ltd.</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Shannon Wu</last_name>
      <phone>+886-2-26971355</phone>
      <phone_ext>1316</phone_ext>
      <email>CR@caliway.com.tw</email>
    </overall_contact>
    <location>
      <facility>
        <name>Investigational Site 1</name>
        <address>
          <city>Omaha</city>
          <state>Nebraska</state>
          <zip>68144</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 10, 2023</study_first_submitted>
    <study_first_submitted_qc>August 17, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 22, 2023</study_first_posted>
    <last_update_submitted>August 17, 2023</last_update_submitted>
    <last_update_submitted_qc>August 17, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 22, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <!-- 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/NCT06005441
  org study id: CBL-0205
  nct id: NCT06005441
  lead sponsor: 
  is fda regulated drug: Yes
  is fda regulated device: No
  This is a randomized, placebo-controlled, Phase 2b study to evaluate the efficacy, safety,
        and tolerability of CBL-514 injection compared with CBL-A1 and CBL-A2 for reducing
        subcutaneous fat.
  A total of approximately 160 adult participants with moderate or severe abdominal fat at
        Screening will be enrolled. Each participant will receive up to 4 treatments of allocated
        study drug administered subcutaneously to the abdomen, once every 3 weeks.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Double (Participant, Outcomes Assessor)
  measure: Percentage of participants with at least 150 mL reduction in abdominal subcutaneous fat volume from Baseline to 8 weeks after the final treatment
  time frame: From Baseline to 8 weeks after the final treatment
  description: Percentage of participants with at least 150 mL reduction in abdominal subcutaneous fat volume from Baseline to 8 weeks after the final treatment, as measured by MRI, of CBL-514 compared with CBL-A1, CBL-A2, and placebo.
  measure: Mean change in abdominal subcutaneous fat volume from Baseline to 4 weeks and 8 weeks post the final treatment
  time frame: From Baseline to 4 weeks and 8 weeks after the final treatment
  description: Mean change in abdominal subcutaneous fat volume from Baseline to 4 weeks and 8 weeks post the final treatment, as measured by MRI, of CBL-514 compared with CBL-A1, CBL-A2, and placebo.
  measure: Percentage of participants with at least 150 mL reduction in abdominal subcutaneous fat volume from Baseline to 4 weeks after the final treatment
  time frame: From Baseline to 4 weeks after the final treatment
  description: Percentage of participants with at least 150 mL reduction in abdominal subcutaneous fat volume from Baseline to 4 weeks after the final treatment, as measured by MRI, of CBL-514 compared with CBL-A1, CBL-A2, and placebo.
  measure: Percentage of participants with at least 200 mL reduction in abdominal subcutaneous fat volume from Baseline to 4 weeks and 8 weeks after the final treatment
  time frame: From Baseline to 4 weeks and 8 weeks after the final treatment
  description: Percentage of participants with at least 200 mL reduction in abdominal subcutaneous fat volume from Baseline to 4 weeks and 8 weeks after the final treatment, as measured by MRI, of CBL-514 compared with CBL-A1, CBL-A2, and placebo.
  measure: Percentage of participants with at least 1-grade improvement reported by the Investigator using the Clinician-Reported Abdominal Fat Rating Scale (CR-AFRS) at 4 weeks and 8 weeks after the final treatment
  time frame: From Baseline to 4 weeks and 8 weeks after the final treatment
  description: Percentage of participants with at least 1-grade improvement reported by the Investigator using the Clinician-Reported Abdominal Fat Rating Scale (CR-AFRS) at 4 weeks and 8 weeks after the final treatment, for CBL-514 compared with CBL-A1, CBL-A2, and placebo.
  Note: The AFRS is a 5-point ordinal scale (0-5) to assess the abdominal fat level based on the presence of fat on abdomen with 1=None/Minimal, 2=Mild, 3=Moderate, 4=Severe and 5=Very Severe.
  measure: Percentage of participants with at least 1-grade improvement reported by the participant using the Patient-Reported Abdominal Fat Rating Scale (PR-AFRS) at 4 weeks and 8 weeks after the final treatment.
  time frame: From Baseline to 4 weeks and 8 weeks after the final treatment
  description: Percentage of participants with at least 1-grade improvement reported by the participant using the Patient-Reported Abdominal Fat Rating Scale (PR-AFRS) at 4 weeks and 8 weeks after the final treatment, for CBL-514 compared with CBL-A1, CBL-A2, and placebo.
  Note: The AFRS is a 5-point ordinal scale (0-5) to assess the abdominal fat level based on the presence of fat on abdomen with 1=None/Minimal, 2=Mild, 3=Moderate, 4=Severe and 5=Very Severe.
  measure: Percentage of participants with at least 1-grade improvement reported by the independent clinician using the Clinician-Reported Abdominal Fat Rating Scale (CR-AFRS) at 4 weeks and 8 weeks after the final treatment.
  time frame: From Baseline to 4 weeks and 8 weeks after the final treatment
  description: Percentage of participants with at least 1-grade improvement reported by the independent clinician using the Clinician-Reported Abdominal Fat Rating Scale (CR-AFRS) at 4 weeks and 8 weeks after the final treatment, for CBL-514 compared with CBL-A1, CBL-A2, and placebo.
  Note: The AFRS is a 5-point ordinal scale (0-5) to assess the abdominal fat level based on the presence of fat on abdomen with 1=None/Minimal, 2=Mild, 3=Moderate, 4=Severe and 5=Very Severe.
  measure: The incidence of treatment-emergent adverse events (TEAEs) as defined in the protocol
  time frame: From Baseline to 8 weeks after the final treatment
  description: Number of participants experiencing TEAEs and number of individual TEAEs
  measure: The incidence of clinically significant abnormal findings as defined in the protocol
  time frame: From Baseline to 8 weeks after the final treatment
  description: Number of participants with clinically significant abnormalities in laboratory tests, vital signs and physical examinations
  arm group label: CBL-514 Injection
  arm group type: Experimental
  description: Participant will receive CBL-514 administered in 2.4 mL injections, up to 120 mL per treatment session at intervals of approximately 3 weeks for up to 4 treatments.
  arm group label: CBL-A1 Injection
  arm group type: Experimental
  description: Participant will receive CBL-A1 administered in 2.4 mL injections, up to 120 mL per treatment session at intervals of approximately 3 weeks for up to 4 treatments.
  arm group label: CBL-A2 Injection
  arm group type: Experimental
  description: Participant will receive CBL-A2 administered in 2.4 mL injections, up to 120 mL per treatment session at intervals of approximately 3 weeks for up to 4 treatments.
  arm group label: 0.9% Sodium Chloride
  arm group type: Placebo Comparator
  description: Participant will receive 0.9% Sodium Chloride administered in 2.4 mL injections, up to 120 mL per treatment session at intervals of approximately 3 weeks for up to 4 treatments.
  intervention type: Drug
  intervention name: CBL-514 injection
  description: Provided as a ready for use injectable CBL-514 solution
  arm group label: CBL-514 Injection
  intervention type: Drug
  intervention name: CBL-A1 Injection
  description: Provided as a ready for use injectable CBL-A1 solution
  arm group label: CBL-A1 Injection
  intervention type: Drug
  intervention name: CBL-A2 Injection
  description: Provided as a ready for use injectable CBL-A2 solution
  arm group label: CBL-A2 Injection
  intervention type: Drug
  intervention name: 0.9% Sodium Chloride
  description: Sodium Chloride (0.9% NaCl) placebo for injection
  arm group label: 0.9% Sodium Chloride
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 64 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Anne Sheu
  role: Study Director
  affiliation: Caliway Biopharmaceuticals Co., Ltd.
  last name: Shannon Wu
  phone: +886-2-26971355
  phone ext: 1316
  email: CR@caliway.com.tw
  facility: 
  country: United States
  responsible party type: Sponsor