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/NCT05980065</url>
    </required_header>
    <id_info>
      <org_study_id>C1K-101</org_study_id>
      <nct_id>NCT05980065</nct_id>
    </id_info>
    <brief_title>To Evaluate the Safety, Tolerability, and Pharmacokinetics After Subcutaneous Administration of C1K in Healthy Subjects</brief_title>
    <official_title>A Dose-block Randomized, Double-blind, Placebo-controlled, Single and Multiple Ascending Dose, First-in-human, Phase 1 Clinical Trial to Evaluate the Safety, Tolerability, and Pharmacokinetics After Subcutaneous Administration of C1K in Healthy Subjects</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Seoul National University Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Ensol Biosciences, Inc.</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Seoul National University Hospital</source>
    <oversight_info>
      <has_dmc>No</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>
        A dose-block randomized, double-blind, placebo-controlled, single and multiple ascending&#xD;
        dose, first-in-human, phase 1 first in human clinical trial to evaluate the safety,&#xD;
        tolerability, and pharmacokinetics after subcutaneous administration of C1K in healthy Korean&#xD;
        subjects.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">December 20, 2022</start_date>
    <completion_date type="Anticipated">September 2023</completion_date>
    <primary_completion_date type="Anticipated">September 2023</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>Triple (Participant, Care Provider, Investigator)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Safety assessment by adverse event monitoring</measure>
      <time_frame>up to 23 days</time_frame>
      <description>Monitoring of adverse event</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Cmax</measure>
      <time_frame>At day 1</time_frame>
      <description>Peak Plasma Concentration</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Cmax</measure>
      <time_frame>At day 15</time_frame>
      <description>Peak Plasma Concentration</description>
    </primary_outcome>
    <primary_outcome>
      <measure>AUC</measure>
      <time_frame>At day 1</time_frame>
      <description>Area under the plasma concentration versus time curve</description>
    </primary_outcome>
    <primary_outcome>
      <measure>AUC</measure>
      <time_frame>At day 15</time_frame>
      <description>Area under the plasma concentration versus time curve</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Safety-Injection site response evaluation</measure>
      <time_frame>up to 23 days</time_frame>
      <description>To evaluate safety</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Systolic blood pressure</measure>
      <time_frame>up to 23 days</time_frame>
      <description>Monitoring of vital signs</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Diastolic blood pressure</measure>
      <time_frame>up to 23 days</time_frame>
      <description>Monitoring of vital signs</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Pulse rate</measure>
      <time_frame>up to 23 days</time_frame>
      <description>Monitoring of vital signs</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>QT interval</measure>
      <time_frame>up to 23 days</time_frame>
      <description>Monitoring of 12-lead electrocardiogram</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>QTc interval</measure>
      <time_frame>up to 23 days</time_frame>
      <description>Monitoring of 12-lead electrocardiogram</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>PR interval</measure>
      <time_frame>up to 23 days</time_frame>
      <description>Monitoring of 12-lead electrocardiogram</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>QRS interval</measure>
      <time_frame>up to 23 days</time_frame>
      <description>Monitoring of 12-lead electrocardiogram</description>
    </secondary_outcome>
    <number_of_arms>5</number_of_arms>
    <enrollment type="Anticipated">35</enrollment>
    <condition>Healthy Subjects</condition>
    <arm_group>
      <arm_group_label>Dose level 1</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>C1K 150mg</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Dose level 2</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>C1K 300mg or placebo</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Dose level 3</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>C1K 600mg or placebo</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Dose level 4</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>C1K 900mg or placebo</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Dose level 5</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>C1K 1200mg or placebo</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>C1K</intervention_name>
      <description>Subcutaneously administrate C1K 150mg at 0 Day 1, Day 8, Day 15</description>
      <arm_group_label>Dose level 1</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>C1K</intervention_name>
      <description>Subcutaneously administrate C1K 300mg at 0 Day 1, Day 8, Day 15</description>
      <arm_group_label>Dose level 2</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Placebo</intervention_name>
      <description>Subcutaneously administrate placebo at 0 Day 1, Day 8, Day 15</description>
      <arm_group_label>Dose level 2</arm_group_label>
      <arm_group_label>Dose level 3</arm_group_label>
      <arm_group_label>Dose level 4</arm_group_label>
      <arm_group_label>Dose level 5</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>C1K</intervention_name>
      <description>Subcutaneously administrate C1K 600mg at 0 Day 1, Day 8, Day 15</description>
      <arm_group_label>Dose level 3</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>C1K</intervention_name>
      <description>Subcutaneously administrate C1K 900mg at 0 Day 1, Day 8, Day 15</description>
      <arm_group_label>Dose level 4</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>C1K</intervention_name>
      <description>Subcutaneously administrate C1K 1200mg at 0 Day 1, Day 8, Day 15</description>
      <arm_group_label>Dose level 5</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Healthy subjects aged 19 - 45 years at the time of screening visit procedure.&#xD;
  &#xD;
            2. The subject weighs in the range of 50.0 - 90.0 kg and has a body mass index (BMI) in&#xD;
               the range 18-27 kg/m2.&#xD;
  &#xD;
            3. Sufficient ability to understand the study after being informed about the study and&#xD;
               provide written informed consent.&#xD;
  &#xD;
            4. Based on physical examination, vital sign, 12-lead ECG and laboratory test etc. and in&#xD;
               the opinion of the investigator, the subject is suitable for the study.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. A subject with clinically significant hepatobiliary, renal, neurologic, respiratory,&#xD;
               endocrine, blood•oncology, cardiovascular, urinary, or, psychical diseases or a&#xD;
               history&#xD;
  &#xD;
            2. A subject who has difficulty with sub-cutaneous injection(ex: tattoo, allergy on skin&#xD;
               etc.)&#xD;
  &#xD;
            3. A subject who has hypersensitivity to the drugs of the drugs containing the same&#xD;
               class, or other drugs, or a history of clinically significant hypersensitivity&#xD;
  &#xD;
            4. A subject who has ventricular tachycardia, ventricular tachycardia, ventricular&#xD;
               flutter or confirmed other ventricular flutter and QTc interval: &gt; 450 ms or the other&#xD;
               clinically significant medical findings&#xD;
  &#xD;
            5. A subject with the following results in the screening test:&#xD;
  &#xD;
                 -  Blood AST (GOT), ALT (GPT): &gt; Normal range upper × 1.5&#xD;
  &#xD;
                 -  Blood CPK &gt; Normal range upper × 1.5&#xD;
  &#xD;
                 -  eGFR (CKD-EPI equation) &lt; 60 mL/min/1.73 m2&#xD;
  &#xD;
            6. Positive serological test (syphilis test, hepatitis B test, hepatitis C test, human&#xD;
               immunodeficiency virus (HIV) test)&#xD;
  &#xD;
            7. A subject with the following results in the screening test:&#xD;
  &#xD;
                 -  systolic blood pressure &lt; 80 mmHg or &gt; 140 mmHg&#xD;
  &#xD;
                 -  diastolic blood pressure &lt; 50 mmHg or &gt; 90 mmHg&#xD;
  &#xD;
            8. A subject with a history of drug abuse or positive urine screening test for drug abuse&#xD;
  &#xD;
            9. A subject who administered any prescription drugs or herbal medicine within 2 weeks&#xD;
               prior to the expected date of the first dose, or any over-the-counter drug (OTC drug)&#xD;
               or vitamin within 1 week prior to the expected date of the first dose (However, can&#xD;
               participate in the study if otherwise decided eligible by the investigator).&#xD;
  &#xD;
           10. A subject who participated in other clinical trial and administered investigational&#xD;
               drug within 6 months prior to the expected date of the first dose&#xD;
  &#xD;
           11. A subject who donated whole blood within 2 months or the component blood within 1&#xD;
               month prior to the expected date of the first dose, or received blood transfusion&#xD;
               within 1 month prior to the expected date of the first dose&#xD;
  &#xD;
           12. Smokers who smoke more than 10 cigarettes/day in the last 3 months as of screening&#xD;
               day.&#xD;
  &#xD;
           13. A subject with persistent alcohol intake (&gt; 21 units/week, 1 unit = 10 g of pure&#xD;
               alcohol), or inability to abstain from drinking from 3 days before the expected date&#xD;
               of the first dose until the last discharge&#xD;
  &#xD;
           14. A male subject who has plan to have a baby or to donate sperm. A female subject who is&#xD;
               pregnant or lactating or has plan to lactate within 3 months after administration of&#xD;
               IP&#xD;
  &#xD;
           15. A subject who is intending to become pregnant during this study or with inability to&#xD;
               use a medically acceptable contraception method(ex. sterilization operation,&#xD;
               intrauterine device etc. for Subject or subject's partner&#xD;
  &#xD;
               ※ medically acceptable contraception method&#xD;
  &#xD;
                 -  Use of intrauterine device which is proven pregnancy failure rates in spouses (or&#xD;
                    partners).&#xD;
  &#xD;
                 -  Use combined blocking contraceptives (for male or female) and antiseptic drugs&#xD;
  &#xD;
                 -  Subject or partner's operation(vasectomized, bilateral tubal occlusion,&#xD;
                    hysterectomy)&#xD;
  &#xD;
           16. Subject who is considered inadequate to participation in the study due to other reason&#xD;
               under investigator's discretion&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>19 Years</minimum_age>
      <maximum_age>45 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>JAESEONG OH</last_name>
      <role>Principal Investigator</role>
      <affiliation>Seoul National University Hospital</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Seoul National University Clinical Trial Center</last_name>
      <phone>82220721681</phone>
      <email>simjungin@snu.ac.kr</email>
    </overall_contact>
    <location>
      <facility>
        <name>Seoul National University Clinical Trial Center</name>
        <address>
          <city>SEoul</city>
          <zip>03080</zip>
          <country>Korea, Republic of</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Seoul National University Clinical Trial Center</last_name>
        <email>simjungin@snu.ac.kr</email>
      </contact>
    </location>
    <location_countries>
      <country>Korea, Republic of</country>
    </location_countries>
    <verification_date>December 2022</verification_date>
    <study_first_submitted>April 19, 2023</study_first_submitted>
    <study_first_submitted_qc>August 3, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 7, 2023</study_first_posted>
    <last_update_submitted>August 3, 2023</last_update_submitted>
    <last_update_submitted_qc>August 3, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 7, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <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/NCT05980065
  org study id: C1K-101
  nct id: NCT05980065
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  A dose-block randomized, double-blind, placebo-controlled, single and multiple ascending
        dose, first-in-human, phase 1 first in human clinical trial to evaluate the safety,
        tolerability, and pharmacokinetics after subcutaneous administration of C1K in healthy Korean
        subjects.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Triple (Participant, Care Provider, Investigator)
  measure: Safety assessment by adverse event monitoring
  time frame: up to 23 days
  description: Monitoring of adverse event
  measure: Cmax
  time frame: At day 1
  description: Peak Plasma Concentration
  measure: Cmax
  time frame: At day 15
  description: Peak Plasma Concentration
  measure: AUC
  time frame: At day 1
  description: Area under the plasma concentration versus time curve
  measure: AUC
  time frame: At day 15
  description: Area under the plasma concentration versus time curve
  measure: Safety-Injection site response evaluation
  time frame: up to 23 days
  description: To evaluate safety
  measure: Systolic blood pressure
  time frame: up to 23 days
  description: Monitoring of vital signs
  measure: Diastolic blood pressure
  time frame: up to 23 days
  description: Monitoring of vital signs
  measure: Pulse rate
  time frame: up to 23 days
  description: Monitoring of vital signs
  measure: QT interval
  time frame: up to 23 days
  description: Monitoring of 12-lead electrocardiogram
  measure: QTc interval
  time frame: up to 23 days
  description: Monitoring of 12-lead electrocardiogram
  measure: PR interval
  time frame: up to 23 days
  description: Monitoring of 12-lead electrocardiogram
  measure: QRS interval
  time frame: up to 23 days
  description: Monitoring of 12-lead electrocardiogram
  arm group label: Dose level 1
  arm group type: Experimental
  description: C1K 150mg
  arm group label: Dose level 2
  arm group type: Experimental
  description: C1K 300mg or placebo
  arm group label: Dose level 3
  arm group type: Experimental
  description: C1K 600mg or placebo
  arm group label: Dose level 4
  arm group type: Experimental
  description: C1K 900mg or placebo
  arm group label: Dose level 5
  arm group type: Experimental
  description: C1K 1200mg or placebo
  intervention type: Drug
  intervention name: C1K
  description: Subcutaneously administrate C1K 150mg at 0 Day 1, Day 8, Day 15
  arm group label: Dose level 1
  intervention type: Drug
  intervention name: C1K
  description: Subcutaneously administrate C1K 300mg at 0 Day 1, Day 8, Day 15
  arm group label: Dose level 2
  intervention type: Drug
  intervention name: Placebo
  description: Subcutaneously administrate placebo at 0 Day 1, Day 8, Day 15
  arm group label: Dose level 2
  arm group label: Dose level 3
  arm group label: Dose level 4
  arm group label: Dose level 5
  intervention type: Drug
  intervention name: C1K
  description: Subcutaneously administrate C1K 600mg at 0 Day 1, Day 8, Day 15
  arm group label: Dose level 3
  intervention type: Drug
  intervention name: C1K
  description: Subcutaneously administrate C1K 900mg at 0 Day 1, Day 8, Day 15
  arm group label: Dose level 4
  intervention type: Drug
  intervention name: C1K
  description: Subcutaneously administrate C1K 1200mg at 0 Day 1, Day 8, Day 15
  arm group label: Dose level 5
  criteria: 
  gender: All
  minimum age: 19 Years
  maximum age: 45 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: JAESEONG OH
  role: Principal Investigator
  affiliation: Seoul National University Hospital
  last name: Seoul National University Clinical Trial Center
  phone: 82220721681
  email: simjungin@snu.ac.kr
  facility: 
  status: Recruiting
  contact: 
  country: Korea, Republic of
  responsible party type: Sponsor
  sharing ipd: No