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/NCT05995782</url>
    </required_header>
    <id_info>
      <org_study_id>FB418_P101</org_study_id>
      <nct_id>NCT05995782</nct_id>
    </id_info>
    <brief_title>A Phase 1, SAD and MAD Study to Evaluate the Safety and Tolerability of FB418</brief_title>
    <official_title>A Phase 1, Randomized, Double-Blind, Placebo-Controlled, SAD and MAD Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Oral FB418 in Healthy Adult Subjects and Healthy Elderly Subjects</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>1ST Biotherapeutics, Inc.</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>1ST Biotherapeutics, Inc.</source>
    <oversight_info>
      <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 purpose of this study is to evaluate the safety, tolerability and pharmacokinetics and&#xD;
        pharmacodynamics of oral doses of FB418 in healthy adult subjects and healthy elderly&#xD;
        subjects.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Part A:&#xD;
  &#xD;
        Primary:&#xD;
  &#xD;
        To assess the safety and tolerability of single ascending oral doses of FB418 in healthy&#xD;
        adult subjects and healthy elderly subjects.&#xD;
  &#xD;
        Secondary:&#xD;
  &#xD;
        To assess the pharmacokinetics (PK) of FB418 and metabolite after single ascending oral doses&#xD;
        of FB418 in healthy adult subjects and healthy elderly subjects.&#xD;
  &#xD;
        To assess the effect of a high-fat meal on the PK of FB418 and metabolite after a single oral&#xD;
        dose of FB418 when administered to healthy adult subjects.&#xD;
  &#xD;
        Part B:&#xD;
  &#xD;
        Primary:&#xD;
  &#xD;
        To assess the safety and tolerability of multiple ascending oral doses FB418 in healthy adult&#xD;
        subjects.&#xD;
  &#xD;
        Secondary:&#xD;
  &#xD;
        To assess the PK of FB418 and metabolite after multiple ascending oral doses of FB418 in&#xD;
        healthy adult subjects.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">December 2023</start_date>
    <completion_date type="Anticipated">December 2024</completion_date>
    <primary_completion_date type="Anticipated">September 2024</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>Treatment Emergent Adverse Events (TEAE)</measure>
      <time_frame>Up to 7 ~ 14 days after the last dose</time_frame>
      <description>Number of TEAEs including serious adverse events (SAEs)</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>PK parameter 1</measure>
      <time_frame>Up to 72 hours after the last dose</time_frame>
      <description>Maximum observed concentration (Cmax) of FB418 in plasma</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>PK parameter 2</measure>
      <time_frame>Up to 72 hours after the last dose</time_frame>
      <description>Time to maximum observed concentration (Tmax) of FB418 in plasma</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>PK parameter 3</measure>
      <time_frame>Up to 72 hours after the last dose</time_frame>
      <description>The area under the concentration-time curve from time zero extrapolated to infinity (AUC0-∞) of FB418 in plasma</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>PK parameter 4</measure>
      <time_frame>Up to 72 hours after the last dose</time_frame>
      <description>Area under the concentration-time curve from time zero to the time of last quantifiable concentration (AUC[0-last]) of FB418 in plasma</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>PK parameter 5</measure>
      <time_frame>Up to 72 hours after the last dose</time_frame>
      <description>Apparent terminal elimination half-life (t1/2) of FB418 in plasma</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">64</enrollment>
    <condition>Parkinson Disease Psychosis</condition>
    <condition>Amyotrophic Lateral Sclerosis (ALS)</condition>
    <arm_group>
      <arm_group_label>FB418</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Part A - Single ascending oral doses of FB418 in healthy adult subjects and healthy elderly subjects.&#xD;
  Part B - Multiple ascending oral doses FB418 in healthy adult subjects.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>FB418-Placebo</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>Part A - Single Ascending Dose matching placebo study Part B - Multiple Ascending Dose matching placebo study</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>FB418</intervention_name>
      <description>Oral dose</description>
      <arm_group_label>FB418</arm_group_label>
      <arm_group_label>FB418-Placebo</arm_group_label>
      <other_name>FB418 active drug</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Key Inclusion Criteria:&#xD;
  &#xD;
            1. Healthy, adult, male 19 55 years of age, inclusive, at the screening.&#xD;
  &#xD;
            2. For elderly subjects(Part A Cohort 5 only), healthy, elderly, male or female (of non&#xD;
               childbearing potential only) over 60 years of age, inclusive, at screening.&#xD;
  &#xD;
            3. In the case of the elderly(Part A Cohort 5 only), they have a history of mild disease,&#xD;
               but can participate if the researcher judges that they can stop taking the drug at&#xD;
               least 2 weeks before the expected first dose or before the half-life is 5 times or&#xD;
               more)&#xD;
  &#xD;
            4. The continuous non smoker who have not used nicotine containing products for at least&#xD;
               3 months prior to (the first) dosing and throughout the study are based on subjective&#xD;
               self reporting.&#xD;
  &#xD;
            5. Body mass index (BMI) ≥ 18 and ≤ 32 kg/m2 at the screening.&#xD;
  &#xD;
            6. Medically healthy with no clinically significant medical history, physical&#xD;
               examination, simplified neurological examination, laboratory profiles, vital signs or&#xD;
               ECGs, as deemed by the PI or designee.&#xD;
  &#xD;
            7. In Cohort 5, A female subject must be of non childbearing potential&#xD;
  &#xD;
          Key Exclusion Criteria:&#xD;
  &#xD;
            1. Is mentally or legally incapacitated or has significant emotional problems at the time&#xD;
               of the screening visit or expected during the conduct of the study.&#xD;
  &#xD;
            2. History or presence of a clinically significant medical or psychiatric condition or&#xD;
               disease in the opinion of the PI or designee.&#xD;
  &#xD;
            3. History of any illness that, in the opinion of the PI or designee, might confound the&#xD;
               results of the study or poses an additional risk to the subject by their participation&#xD;
               in the study.&#xD;
  &#xD;
            4. Is at suicidal risk in the opinion of the PI as per the following criteria:&#xD;
  &#xD;
                 1. Any suicide attempts within 12 months prior to screening or any suicidal intent,&#xD;
                    including a plan, within 3 months prior to screening.&#xD;
  &#xD;
                 2. C-SSRS answer of &quot;YES&quot; on suicidal ideation within 3 months prior to screening.&#xD;
  &#xD;
            5. History or presence of alcoholism or drug abuse within the past 2 years prior to (the&#xD;
               first) dosing.&#xD;
  &#xD;
            6. History or presence of hypersensitivity or idiosyncratic reaction to the study drug or&#xD;
               related compounds.&#xD;
  &#xD;
            7. History of seizures (childhood febrile seizures are excepted).&#xD;
  &#xD;
            8. Positive urine drug or alcohol results at screening or check in.&#xD;
  &#xD;
            9. Has an abnormal screening ECG indicating a second- or third- degree AV block, or one&#xD;
               or more of the following: QRS &gt; 120 msec, QTcF &gt; 450 msec for males and &gt; 460 msec for&#xD;
               females, PR interval &gt; 220 msec. Any rhythm other than normal sinus rhythm, which is&#xD;
               interpreted by the PI or designee to be clinically significant at screening or&#xD;
               check-in.&#xD;
  &#xD;
           10. Has any medical or surgical condition in which lumbar puncture is contraindicated in&#xD;
               the opinion of the PI.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>19 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>1STBIO study manager</last_name>
      <role>Study Director</role>
      <affiliation>1ST Biotherapeutics, Inc.</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>1STBIO information team</last_name>
      <phone>+82-31-895-4677</phone>
      <email>info@1stbio.com</email>
    </overall_contact>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 7, 2023</study_first_submitted>
    <study_first_submitted_qc>August 13, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 16, 2023</study_first_posted>
    <last_update_submitted>August 13, 2023</last_update_submitted>
    <last_update_submitted_qc>August 13, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 16, 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>Parkinson Disease</mesh_term>
      <mesh_term>Motor Neuron Disease</mesh_term>
      <mesh_term>Amyotrophic Lateral Sclerosis</mesh_term>
    </condition_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/NCT05995782
  org study id: FB418_P101
  nct id: NCT05995782
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  is us export: No
  The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics and
        pharmacodynamics of oral doses of FB418 in healthy adult subjects and healthy elderly
        subjects.
  Part A:
  
        Primary:
  
        To assess the safety and tolerability of single ascending oral doses of FB418 in healthy
        adult subjects and healthy elderly subjects.
  
        Secondary:
  
        To assess the pharmacokinetics (PK) of FB418 and metabolite after single ascending oral doses
        of FB418 in healthy adult subjects and healthy elderly subjects.
  
        To assess the effect of a high-fat meal on the PK of FB418 and metabolite after a single oral
        dose of FB418 when administered to healthy adult subjects.
  
        Part B:
  
        Primary:
  
        To assess the safety and tolerability of multiple ascending oral doses FB418 in healthy adult
        subjects.
  
        Secondary:
  
        To assess the PK of FB418 and metabolite after multiple ascending oral doses of FB418 in
        healthy adult subjects.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Triple (Participant, Care Provider, Investigator)
  measure: Treatment Emergent Adverse Events (TEAE)
  time frame: Up to 7 ~ 14 days after the last dose
  description: Number of TEAEs including serious adverse events (SAEs)
  measure: PK parameter 1
  time frame: Up to 72 hours after the last dose
  description: Maximum observed concentration (Cmax) of FB418 in plasma
  measure: PK parameter 2
  time frame: Up to 72 hours after the last dose
  description: Time to maximum observed concentration (Tmax) of FB418 in plasma
  measure: PK parameter 3
  time frame: Up to 72 hours after the last dose
  description: The area under the concentration-time curve from time zero extrapolated to infinity (AUC0-∞) of FB418 in plasma
  measure: PK parameter 4
  time frame: Up to 72 hours after the last dose
  description: Area under the concentration-time curve from time zero to the time of last quantifiable concentration (AUC[0-last]) of FB418 in plasma
  measure: PK parameter 5
  time frame: Up to 72 hours after the last dose
  description: Apparent terminal elimination half-life (t1/2) of FB418 in plasma
  arm group label: FB418
  arm group type: Experimental
  description: Part A - Single ascending oral doses of FB418 in healthy adult subjects and healthy elderly subjects.
  Part B - Multiple ascending oral doses FB418 in healthy adult subjects.
  arm group label: FB418-Placebo
  arm group type: Placebo Comparator
  description: Part A - Single Ascending Dose matching placebo study Part B - Multiple Ascending Dose matching placebo study
  intervention type: Drug
  intervention name: FB418
  description: Oral dose
  arm group label: FB418
  arm group label: FB418-Placebo
  other name: FB418 active drug
  criteria: 
  gender: All
  minimum age: 19 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: 1STBIO study manager
  role: Study Director
  affiliation: 1ST Biotherapeutics, Inc.
  last name: 1STBIO information team
  phone: +82-31-895-4677
  email: info@1stbio.com
  responsible party type: Sponsor
  mesh term: Parkinson Disease
  mesh term: Motor Neuron Disease
  mesh term: Amyotrophic Lateral Sclerosis
  sharing ipd: No