<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/NCT03830125</url>
  </required_header>
  <id_info>
    <org_study_id>BBT877-IPF-001</org_study_id>
    <nct_id>NCT03830125</nct_id>
  </id_info>
  <brief_title>Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BBT-877 in Healthy Subjects</brief_title>
  <official_title>A Phase 1, 2-Stage, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BBT-877 Following Single and Multiple Ascending Doses in Healthy Adult Subjects</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Bridge Biotherapeutics, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>KCRN Research, LLC</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Bridge Biotherapeutics, Inc.</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 clinical trial is the first-in-human study of BBT-877. The purpose of this phase 1 study&#xD;
      is to assess the safety and tolerability of single and multiple ascending oral doses of&#xD;
      BBT-877 in healthy adult subjects.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 13, 2019</start_date>
  <completion_date type="Actual">November 24, 2019</completion_date>
  <primary_completion_date type="Actual">November 24, 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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The number and severity of treatment emergent adverse events (TEAEs)</measure>
    <time_frame>7 days after the last dose</time_frame>
    <description>To assess the safety and tolerability of single and multiple ascending oral doses of BBT-877 in healthy adult subjects.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Peak Plasma Concentration of BBT-877 in plasma</measure>
    <time_frame>72 hours after the last dose</time_frame>
    <description>The PK of BBT-877</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area under the plasma concentration versus time curve of BBT-877 in plasma</measure>
    <time_frame>72 hours after the last dose</time_frame>
    <description>The PK of BBT-877</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Peak Plasma Concentration of BBT-877 in plasma under fed condition.</measure>
    <time_frame>72 hours after the last dose</time_frame>
    <description>The food effect on the PK of a single dose of BBT-877</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area under the plasma concentration versus time curve of BBT-877 in plasma under fed condition.</measure>
    <time_frame>72 hours after the last dose</time_frame>
    <description>The food effect on the PK of a single dose of BBT-877</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Raw and change-from-baseline values of plasma LPAs</measure>
    <time_frame>72 hours after the last dose</time_frame>
    <description>To assess the PD of BBT-877 by assessment of plasma LPAs.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">88</enrollment>
  <condition>Idiopathic Pulmonary Fibrosis</condition>
  <arm_group>
    <arm_group_label>Single Ascending Doses</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Multiple Ascending Doses</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>BBT-877, Single dose</intervention_name>
    <description>Single dose of BBT-877, 5 dose levels, oral capsule</description>
    <arm_group_label>Single Ascending Doses</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo group</intervention_name>
    <description>Placebo matched to BBT-877, oral capsule</description>
    <arm_group_label>Multiple Ascending Doses</arm_group_label>
    <arm_group_label>Single Ascending Doses</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>BBT-877, Multiple doses</intervention_name>
    <description>Multiple doses of BBT-877, 14 days, 8 dose levels, oral capsule</description>
    <arm_group_label>Multiple Ascending Doses</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy adult male and/or female (non-childbearing potential only), 19 to 55 years of&#xD;
             age, inclusive, at screening.&#xD;
&#xD;
          -  Continuous non-smoker who has not used nicotine-containing products for at least 3&#xD;
             months prior to the first dose and throughout the study.&#xD;
&#xD;
          -  BMI ≥ 18.5 and ≤ 32.0 kg/m2 and weight ≥ 50 kg at screening.&#xD;
&#xD;
          -  Medically healthy with no clinically significant medical history, physical&#xD;
             examination, laboratory profiles, vital signs, as deemed by the PI or designee.&#xD;
&#xD;
          -  No clinically significant history or presence of ECG findings as judged by the PI or&#xD;
             qualified designee at screening and check-in.&#xD;
&#xD;
          -  For a female, must be of non-childbearing potential and therefore must have undergone&#xD;
             one of the following sterilization procedures, at least 6 months prior to the first&#xD;
             dose:&#xD;
&#xD;
               1. hysteroscopic sterilization;&#xD;
&#xD;
               2. bilateral tubal ligation or bilateral salpingectomy;&#xD;
&#xD;
               3. hysterectomy;&#xD;
&#xD;
               4. bilateral oophorectomy; or be postmenopausal with amenorrhea for at least 1 year&#xD;
                  prior to the first dose and follicle-stimulating hormone (FSH) serum levels&#xD;
                  consistent with postmenopausal status.&#xD;
&#xD;
          -  A non-vasectomized, male subject must agree to use a condom with spermicide or abstain&#xD;
             from sexual intercourse during the study until 90 days beyond the last dose of study&#xD;
             drug. (No restrictions are required for a vasectomized male provided his vasectomy has&#xD;
             been performed 4 months or more prior to the first dose of study drug. A male who has&#xD;
             been vasectomized less than 4 months prior to the first dose must follow the same&#xD;
             restrictions as a non-vasectomized male).&#xD;
&#xD;
          -  If male, must agree to not donate sperm from the first dose until 90 days after the&#xD;
             last dose of study drug.&#xD;
&#xD;
          -  Must have the ability to understand and sign a written informed consent form (ICF),&#xD;
             which must be obtained prior to initiation of study procedures.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subject is mentally or legally incapacitated or has significant emotional problems at&#xD;
             the time of the screening visit or expected during the conduct of the study.&#xD;
&#xD;
          -  History or presence of clinically significant medical or psychiatric condition or&#xD;
             disease in the opinion of the PI or designee.&#xD;
&#xD;
          -  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;
          -  History or presence of alcoholism or drug abuse within the past 2 years prior to the&#xD;
             first dose or regular alcohol consumption within 6 months prior to the first dose with&#xD;
             an average weekly intake of greater than 21 glasses/units per week for males or 14&#xD;
             glasses/units per week for females, with one unit = 150 mL of wine or 360 mL of beer&#xD;
             or 45 mL of 45% alcohol.&#xD;
&#xD;
          -  History or presence of hypersensitivity or idiosyncratic reaction to the study drug(s)&#xD;
             or related compounds.&#xD;
&#xD;
          -  History of anemia or history of decreased red blood cells (RBC).&#xD;
&#xD;
          -  Estimated creatinine clearance &lt;80 mL/min at screening.&#xD;
&#xD;
          -  Liver function tests (serum ALT, AST, alkaline phosphatase) and serum bilirubin (total&#xD;
             and direct) &gt; ULN.&#xD;
&#xD;
          -  Baseline hemoglobin, hematocrit, RBC &lt; lower limit of normal at screening and Day -1.&#xD;
&#xD;
          -  Female subjects who are pregnant or who are lactating.&#xD;
&#xD;
          -  Positive urine drug or alcohol results at screening or check-in.&#xD;
&#xD;
          -  Positive urine cotinine at screening.&#xD;
&#xD;
          -  Positive results at screening for human immunodeficiency virus (HIV), hepatitis B&#xD;
             surface antigen (HBsAg), or hepatitis C antibodies (HCV).&#xD;
&#xD;
          -  Unable to refrain from or anticipates the use of:&#xD;
&#xD;
               -  Any drug, including prescription and non-prescription medications, herbal&#xD;
                  remedies, or vitamin supplements beginning approximately 14 days prior to the&#xD;
                  first dose and throughout the study. Hormone replacement therapy will not be&#xD;
                  allowed. After first dosing, acetaminophen (up to 2 g per 24 hours) may be&#xD;
                  administered at the discretion of the PI or designee.&#xD;
&#xD;
               -  Any drugs known to be significant inducers of CYP3A enzymes and/or&#xD;
                  P-glycoprotein, including St. John's Wort, for 28 days prior to the first dosing&#xD;
                  and throughout the study. Appropriate sources (e.g., Flockhart Table) will be&#xD;
                  consulted to confirm lack of PK/PD interaction with study drug.&#xD;
&#xD;
          -  Has been on a diet incompatible with the on-study diet, in the opinion of the PI or&#xD;
             designee, within the 28 days prior to the first dose and throughout the study.&#xD;
&#xD;
          -  Donation of blood or significant blood loss within 56 days prior to the first dose.&#xD;
&#xD;
          -  Plasma donation within 7 days prior to the first dose.&#xD;
&#xD;
          -  Exposure to more than four new chemical entities within 12 months prior to first&#xD;
             dosing day.&#xD;
&#xD;
          -  The subject has participated in a clinical trial and has received an investigational&#xD;
             product within 30 days, or 5 half-lives of the investigational product (whichever is&#xD;
             longer) of the first dose of study drug in the current study.&#xD;
&#xD;
          -  Any condition or circumstance, in the opinion of the PI or designee, which may make&#xD;
             the subject unlikely to complete the study or comply with study procedures and&#xD;
             requirements, or may pose a risk to the subject's safety.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jeong-Hyun Ryou, M.D., Ph.D.</last_name>
    <role>Study Director</role>
    <affiliation>Bridge Biotherapeutics, Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Celerion</name>
      <address>
        <city>Lincoln</city>
        <state>Nebraska</state>
        <zip>68502</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2020</verification_date>
  <study_first_submitted>January 31, 2019</study_first_submitted>
  <study_first_submitted_qc>February 2, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 5, 2019</study_first_posted>
  <last_update_submitted>January 15, 2020</last_update_submitted>
  <last_update_submitted_qc>January 15, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">January 18, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Autotaxin</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pulmonary Fibrosis</mesh_term>
    <mesh_term>Idiopathic Pulmonary Fibrosis</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/NCT03830125
org study id: BBT877-IPF-001
nct id: NCT03830125
lead sponsor: 
collaborator: 
is fda regulated drug: Yes
is fda regulated device: No
This clinical trial is the first-in-human study of BBT-877. The purpose of this phase 1 study
      is to assess the safety and tolerability of single and multiple ascending oral doses of
      BBT-877 in healthy adult subjects.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: The number and severity of treatment emergent adverse events (TEAEs)
time frame: 7 days after the last dose
description: To assess the safety and tolerability of single and multiple ascending oral doses of BBT-877 in healthy adult subjects.
measure: Peak Plasma Concentration of BBT-877 in plasma
time frame: 72 hours after the last dose
description: The PK of BBT-877
measure: Area under the plasma concentration versus time curve of BBT-877 in plasma
time frame: 72 hours after the last dose
description: The PK of BBT-877
measure: Peak Plasma Concentration of BBT-877 in plasma under fed condition.
time frame: 72 hours after the last dose
description: The food effect on the PK of a single dose of BBT-877
measure: Area under the plasma concentration versus time curve of BBT-877 in plasma under fed condition.
time frame: 72 hours after the last dose
description: The food effect on the PK of a single dose of BBT-877
measure: Raw and change-from-baseline values of plasma LPAs
time frame: 72 hours after the last dose
description: To assess the PD of BBT-877 by assessment of plasma LPAs.
arm group label: Single Ascending Doses
arm group type: Experimental
arm group label: Multiple Ascending Doses
arm group type: Experimental
intervention type: Drug
intervention name: BBT-877, Single dose
description: Single dose of BBT-877, 5 dose levels, oral capsule
arm group label: Single Ascending Doses
intervention type: Drug
intervention name: Placebo group
description: Placebo matched to BBT-877, oral capsule
arm group label: Multiple Ascending Doses
arm group label: Single Ascending Doses
intervention type: Drug
intervention name: BBT-877, Multiple doses
description: Multiple doses of BBT-877, 14 days, 8 dose levels, oral capsule
arm group label: Multiple Ascending Doses
criteria: 
gender: All
minimum age: 19 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Jeong-Hyun Ryou, M.D., Ph.D.
role: Study Director
affiliation: Bridge Biotherapeutics, Inc.
facility: 
country: United States
responsible party type: Sponsor
mesh term: Pulmonary Fibrosis
mesh term: Idiopathic Pulmonary Fibrosis