<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/NCT04476303</url>
  </required_header>
  <id_info>
    <org_study_id>BEY-2019-01</org_study_id>
    <nct_id>NCT04476303</nct_id>
  </id_info>
  <brief_title>A Study to Evaluate the Pharmacokinetics and Safety of BEY2153 in Healthy Participants</brief_title>
  <official_title>A Randomized, Double-blind, Placebo-controlled, Single and Multiple Ascending Dose Phase I Clinical Trial to Evaluate the Safety, Tolerability and Pharmacokinetics of BEY2153 After Oral Administration in Healthy Young and Elderly Male Volunteers.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>BeyondBio Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>BeyondBio Inc.</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a first in human Phase 1 study to evaluate the safety, tolerability and&#xD;
      pharmacokinetics with healthy young and elderly adult male volunteers after receiving single&#xD;
      and multiple ascending dose of BEY2153.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Healthy young and elderly adult volunteers who meet the criteria, will be treated single and&#xD;
      multiple ascending dose of BEY2153 or placebo orally. Food effect evaluation study will be&#xD;
      conducted with single ascending dose. After the single ascending dose study, independent&#xD;
      external experts will review blinded data and multiple ascending dose study will be&#xD;
      conducted.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">August 28, 2020</start_date>
  <completion_date type="Anticipated">October 2021</completion_date>
  <primary_completion_date type="Anticipated">October 2021</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>Maximum observed plasma concentration (Cmax)</measure>
    <time_frame>Day 1 to Day 9</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Area Under the Curve (AUC)</measure>
    <time_frame>Day 1 to Day 9</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Apparent terminal elimination half-life (t1/2)</measure>
    <time_frame>Day 1 to Day 9</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Apparent clearance (CL/F)</measure>
    <time_frame>Day 1 to Day 9</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Apparent volume of distribution (Vz/F)</measure>
    <time_frame>Day 1 to Day 9</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Incidence of Adverse Events (AEs)</measure>
    <time_frame>Up to 48 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of Serious Adverse Events (SAEs)</measure>
    <time_frame>Up to 48 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of clinically significant changes in vital signs</measure>
    <time_frame>Up to 18 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of clinically significant changes in 12-Lead electrocardiogram (ECG) parameters</measure>
    <time_frame>Up to 18 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of clinically significant changes in clinical laboratory results</measure>
    <time_frame>Up to 18 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of clinically significant changes in physical examination</measure>
    <time_frame>Up to 18 days</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">88</enrollment>
  <condition>Alzheimer's Disease</condition>
  <arm_group>
    <arm_group_label>SAD (#6 Cohort)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Drug: BEY2153 or placebo subjects will receive single ascending dose of BEY2153 or placebo once.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>SAD (#1 Cohort) - Food effect evaluation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Drug: BEY2153 or placebo subjects will receive single ascending dose of BEY2153 or placebo for two periods at 7 days interval, with both fasting and after high fat meal.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>MAD (#4 Cohort)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Drug: BEY2153 or placebo subjects will receive multiple ascending dose of BEY2153 or placebo for 7 days.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>BEY2153</intervention_name>
    <description>Capsule</description>
    <arm_group_label>MAD (#4 Cohort)</arm_group_label>
    <arm_group_label>SAD (#1 Cohort) - Food effect evaluation</arm_group_label>
    <arm_group_label>SAD (#6 Cohort)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Young adult: A healthy Korean male aged 19 to 45 (inclusive) years at the time of&#xD;
             screening Elderly adult: A healthy Korean male aged over 65 (inclusive) years at the&#xD;
             time of screening&quot;&#xD;
&#xD;
          2. Subjects weighing between 55 kg and 90 kg with BMI between 18.0 and 27.0 kg/m2&#xD;
             (inclusive) at screening.&#xD;
&#xD;
          3. Subjects who have listened to the detailed description of this clinical trial and have&#xD;
             fully understood, and who have agreed in writing to voluntarily participate and&#xD;
             observe the precautions prior to receiving any of the screening procedures&#xD;
&#xD;
          4. Subjects who is eligible for this clinical trial by the investigator's judgement with&#xD;
             laboratory test results and physical-examination findings and etc.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Young adult / Elderly adult: Subjects with evidence or a history of clinically&#xD;
             significant hepatic, renal, neurologic, immunologic, pulmonary, endocrine or&#xD;
             hematological, neoplastic, cardiovascular, psychiatric diseases (mood disorder,&#xD;
             obsessive-compulsive disorder etc.).&#xD;
&#xD;
          2. Subjects with evidence or a history of gastrointestinal disease or with history of&#xD;
             gastrointestinal surgery that may affect assessment of safety, PK characteristics of&#xD;
             study drug.&#xD;
&#xD;
          3. Subjects who showed significant abnormalities at neurologic examination at screening&#xD;
             visit.&#xD;
&#xD;
          4. Subjects who showed any abnormalities at vital signs&#xD;
&#xD;
          5. Subjects who showed any abnormalities at blood test&#xD;
&#xD;
          6. Subjects with serum AST (SGOT) or ALT (SGPT) level or total bilirubin exceed 1.5 times&#xD;
             the upper limit of the normal range at screening&#xD;
&#xD;
          7. Subjects who showed any abnormalities at ECG subsection&#xD;
&#xD;
          8. Subjects who are hypersensitive to drugs, or who have clinically significant&#xD;
             hypersensitivity reactions history.&#xD;
&#xD;
          9. Subjects with a history of alcohol or drug abuse or subjects who showed positive&#xD;
             results for abuse drug at urine drug screening test.&#xD;
&#xD;
         10. Subjects who consume alcohol continuously or who are unable to abstain from drinking&#xD;
             from the time of consent until the end of the clinical trial.&#xD;
&#xD;
         11. Smokers&#xD;
&#xD;
         12. Subjects who had recessive disease, symptomatic infection, virus, bacteria or fungus&#xD;
             infection 1 week before the first study drug administration.&#xD;
&#xD;
         13. Subjects who have taken any prescribed drug or herbal medicine within two weeks prior&#xD;
             to the first study drug administration. Non-prescribed medicine (OTC) or vitamin&#xD;
             supplement prohibit within one week prior to the first study drug administration or&#xD;
             subjects whose administrations are predicted.&#xD;
&#xD;
         14. Subjects who have participated and taken investigational drug in any other clinical&#xD;
             trial within six months prior to study drug administration&#xD;
&#xD;
         15. Subjects who showed positive result for HBs antigen, HCV antibody, HIV&#xD;
             antigen-antibody test at screening&#xD;
&#xD;
         16. Subjects who had whole blood donation, apheresis or blood transfusion within 3 months&#xD;
             before the first study drug administration.&#xD;
&#xD;
         17. Subjects who had grapefruit containing food from 3 days before the scheduled date of&#xD;
             the first study drug administration to discharge and those who cannot be prevented&#xD;
             from taking it during the study period.&#xD;
&#xD;
         18. Subjects who consume or are unable to abstain from products containing caffeine from 3&#xD;
             days before the scheduled date of the first study drug administration to discharge,&#xD;
             and those who cannot be prevented from taking it during the study period.&#xD;
&#xD;
         19. Subjects who do not agree to use following medically appropriate method of&#xD;
             contraception and not to donate sperm starting from subject enrollment to 90 days&#xD;
             after last administration of investigational product.&#xD;
&#xD;
         20. Subjects judged ineligible for the study after a review of the clinical laboratory&#xD;
             results by the investigator or for other reasons.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Seoul National University Hospital</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Beyondbio Inc.</last_name>
      <phone>+82-42-716-0020</phone>
      <email>clinicaltrials@beyondbio.co.kr</email>
    </contact>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>November 2020</verification_date>
  <study_first_submitted>July 13, 2020</study_first_submitted>
  <study_first_submitted_qc>July 14, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 20, 2020</study_first_posted>
  <last_update_submitted>November 26, 2020</last_update_submitted>
  <last_update_submitted_qc>November 26, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">November 30, 2020</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>Alzheimer Disease</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT04476303
org study id: BEY-2019-01
nct id: NCT04476303
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
This is a first in human Phase 1 study to evaluate the safety, tolerability and
      pharmacokinetics with healthy young and elderly adult male volunteers after receiving single
      and multiple ascending dose of BEY2153.
Healthy young and elderly adult volunteers who meet the criteria, will be treated single and
      multiple ascending dose of BEY2153 or placebo orally. Food effect evaluation study will be
      conducted with single ascending dose. After the single ascending dose study, independent
      external experts will review blinded data and multiple ascending dose study will be
      conducted.
allocation: Randomized
intervention model: Sequential Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Maximum observed plasma concentration (Cmax)
time frame: Day 1 to Day 9
measure: Area Under the Curve (AUC)
time frame: Day 1 to Day 9
measure: Apparent terminal elimination half-life (t1/2)
time frame: Day 1 to Day 9
measure: Apparent clearance (CL/F)
time frame: Day 1 to Day 9
measure: Apparent volume of distribution (Vz/F)
time frame: Day 1 to Day 9
measure: Incidence of Adverse Events (AEs)
time frame: Up to 48 days
measure: Incidence of Serious Adverse Events (SAEs)
time frame: Up to 48 days
measure: Incidence of clinically significant changes in vital signs
time frame: Up to 18 days
measure: Incidence of clinically significant changes in 12-Lead electrocardiogram (ECG) parameters
time frame: Up to 18 days
measure: Incidence of clinically significant changes in clinical laboratory results
time frame: Up to 18 days
measure: Incidence of clinically significant changes in physical examination
time frame: Up to 18 days
arm group label: SAD (#6 Cohort)
arm group type: Experimental
description: Drug: BEY2153 or placebo subjects will receive single ascending dose of BEY2153 or placebo once.
arm group label: SAD (#1 Cohort) - Food effect evaluation
arm group type: Experimental
description: Drug: BEY2153 or placebo subjects will receive single ascending dose of BEY2153 or placebo for two periods at 7 days interval, with both fasting and after high fat meal.
arm group label: MAD (#4 Cohort)
arm group type: Experimental
description: Drug: BEY2153 or placebo subjects will receive multiple ascending dose of BEY2153 or placebo for 7 days.
intervention type: Drug
intervention name: BEY2153
description: Capsule
arm group label: MAD (#4 Cohort)
arm group label: SAD (#1 Cohort) - Food effect evaluation
arm group label: SAD (#6 Cohort)
criteria: 
gender: Male
minimum age: 19 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
status: Recruiting
contact: 
country: Korea, Republic of
responsible party type: Sponsor
mesh term: Alzheimer Disease