<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/NCT03775278</url>
  </required_header>
  <id_info>
    <org_study_id>PHP-303-N102</org_study_id>
    <nct_id>NCT03775278</nct_id>
  </id_info>
  <brief_title>A Study of Safety, Tolerability, and Pharmacokinetics of Multiple-Ascending Doses of PHP-303 in Otherwise Healthy Overweight or Obese Subjects</brief_title>
  <official_title>A Phase 1, Single-Center, Randomized, Double-Blind, Placebo-Controlled, Multiple-Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of PHP-303 in Otherwise Healthy Overweight or Obese Subjects</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>pH Pharma</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>pH Pharma</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <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 Phase 1, randomized, double-blind, placebo-controlled multiple-ascending dose (MAD)&#xD;
      study designed to evaluate the safety, tolerability, and pharmacokinetics (PK) of PHP-303 in&#xD;
      otherwise healthy overweight or obese volunteer subjects. Within each ascending dose cohort,&#xD;
      subjects will be randomized in a 4:1 ratio to receive PHP-303 or placebo. The primary&#xD;
      objective is to establish the safety and tolerability and maximum tolerated dose (MTD) of&#xD;
      orally-administered PHP-303.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 17, 2018</start_date>
  <completion_date type="Actual">April 7, 2020</completion_date>
  <primary_completion_date type="Actual">July 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>Sequential Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Safety and tolerability of multiple oral doses of PHP-303 - Incidence of Adverse Events</measure>
    <time_frame>Up to 12 weeks</time_frame>
    <description>Assess the number of patients with adverse events</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Safety and tolerability of multiple oral doses of PHP-303 - number of patients with abnormal ECG</measure>
    <time_frame>Up to 12 weeks</time_frame>
    <description>Number of patients with clinically significant change from baseline in standard 12 lead ECG parameters</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Safety and tolerability of multiple oral doses of PHP-303 - blood pressure</measure>
    <time_frame>Up to 12 weeks</time_frame>
    <description>Number of patients with clinically significant change from baseline in systolic and diastolic blood pressure</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Safety and tolerability of multiple oral doses of PHP-303 - heart rate</measure>
    <time_frame>Up to 12 weeks</time_frame>
    <description>Measured as number of heart beats per minute</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Safety and tolerability of multiple oral doses of PHP-303 - body temperature</measure>
    <time_frame>Up to 12 weeks</time_frame>
    <description>Measurement of oral body temperature</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Safety and tolerability of multiple oral doses of PHP-303 - respiratory rate</measure>
    <time_frame>Up to 12 weeks</time_frame>
    <description>Measured by number of breaths per minute</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Plasma concentration of multiple oral doses of PHP-303 - AUC</measure>
    <time_frame>Plasma Up to 12 weeks</time_frame>
    <description>Area under the curve</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Plasma concentration of multiple oral doses of PHP-303 - Cmax</measure>
    <time_frame>Up to 12 weeks</time_frame>
    <description>Maximum observed concentration</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Plasma concentration of multiple oral doses of PHP-303 - Tmax</measure>
    <time_frame>Up to 12 weeks</time_frame>
    <description>Time to reach maximum measured plasma concentration</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Plasma concentration of multiple oral doses of PHP-303 - t1/2</measure>
    <time_frame>Up to 12 weeks</time_frame>
    <description>Determination of half-life</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">50</enrollment>
  <condition>Otherwise Healthy Overweight or Obese</condition>
  <arm_group>
    <arm_group_label>Experimental</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>PHP-303, multiple oral dose, up to 5 ascending dose cohorts</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo, multiple oral dose, up to 5 ascending dose cohorts</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>PHP-303</intervention_name>
    <description>Investigational drug</description>
    <arm_group_label>Experimental</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Matching placebo</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or female subjects, ≥ 18 to ≤ 60 years of age.&#xD;
&#xD;
          -  In good general health having no clinically significant diseases in medical history or&#xD;
             evidence of clinically significant findings on physical examination, vital signs,&#xD;
             laboratory results, and/or ECG at Screening, in the opinion of an Investigator.&#xD;
&#xD;
          -  Willing to forego other forms of experimental treatment during the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any clinically significant condition that, in the opinion of an Investigator, could&#xD;
             preclude the safe participation of the subject in the study or would prevent the&#xD;
             subject from meeting the study requirements.&#xD;
&#xD;
          -  Major surgery in the 6 months preceding Screening.&#xD;
&#xD;
          -  Clinically-significant abnormal laboratory parameters.&#xD;
&#xD;
          -  Positive urine drug test for alcohol, cotinine, and/or drugs of abuse (cocaine,&#xD;
             tetrahydrocannabinol, amphetamines, methamphetamines, or benzodiazepines) at Screening&#xD;
             or on admission to the study site.&#xD;
&#xD;
          -  Electrocardiographic Fridericia's corrected QT interval (QTcF) interval &gt; 450 msec for&#xD;
             males and &gt; 470 msec for females, or any other clinically significant&#xD;
             electrocardiographic abnormality.&#xD;
&#xD;
          -  Blood pressure results &gt; 150 mmHg systolic or &gt; 95 mmHg diastolic&#xD;
&#xD;
          -  Female subject who is pregnant (positive pregnancy test at the Screening Visit or on&#xD;
             admission to the study site), lactating, or planning to become pregnant during the&#xD;
             study period or within 3 months after the final dose of study medication.&#xD;
&#xD;
          -  History of drug or alcohol abuse or dependence within 1 year prior to Screening.&#xD;
&#xD;
          -  History of cigarette smoking within 3 months of Screening.&#xD;
&#xD;
          -  Known intolerance to lactose.&#xD;
&#xD;
          -  Regular use of prescription drugs within 14 days of the first administration of study&#xD;
             drug or non-prescription (over-the-counter) drugs within 7 days of the first&#xD;
             administration of study drug or unwilling to abstain from prohibited medications&#xD;
             through the end of study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Andrew Nicholls, MD, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>pH Pharma Inc</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Vince &amp; Associates Clinical Research, Inc.</name>
      <address>
        <city>Overland Park</city>
        <state>Kansas</state>
        <zip>66212</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2020</verification_date>
  <study_first_submitted>December 12, 2018</study_first_submitted>
  <study_first_submitted_qc>December 12, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 13, 2018</study_first_posted>
  <last_update_submitted>April 9, 2020</last_update_submitted>
  <last_update_submitted_qc>April 9, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">April 13, 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>Overweight</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/NCT03775278
org study id: PHP-303-N102
nct id: NCT03775278
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
This is a Phase 1, randomized, double-blind, placebo-controlled multiple-ascending dose (MAD)
      study designed to evaluate the safety, tolerability, and pharmacokinetics (PK) of PHP-303 in
      otherwise healthy overweight or obese volunteer subjects. Within each ascending dose cohort,
      subjects will be randomized in a 4:1 ratio to receive PHP-303 or placebo. The primary
      objective is to establish the safety and tolerability and maximum tolerated dose (MTD) of
      orally-administered PHP-303.
allocation: Randomized
intervention model: Sequential Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Safety and tolerability of multiple oral doses of PHP-303 - Incidence of Adverse Events
time frame: Up to 12 weeks
description: Assess the number of patients with adverse events
measure: Safety and tolerability of multiple oral doses of PHP-303 - number of patients with abnormal ECG
time frame: Up to 12 weeks
description: Number of patients with clinically significant change from baseline in standard 12 lead ECG parameters
measure: Safety and tolerability of multiple oral doses of PHP-303 - blood pressure
time frame: Up to 12 weeks
description: Number of patients with clinically significant change from baseline in systolic and diastolic blood pressure
measure: Safety and tolerability of multiple oral doses of PHP-303 - heart rate
time frame: Up to 12 weeks
description: Measured as number of heart beats per minute
measure: Safety and tolerability of multiple oral doses of PHP-303 - body temperature
time frame: Up to 12 weeks
description: Measurement of oral body temperature
measure: Safety and tolerability of multiple oral doses of PHP-303 - respiratory rate
time frame: Up to 12 weeks
description: Measured by number of breaths per minute
measure: Plasma concentration of multiple oral doses of PHP-303 - AUC
time frame: Plasma Up to 12 weeks
description: Area under the curve
measure: Plasma concentration of multiple oral doses of PHP-303 - Cmax
time frame: Up to 12 weeks
description: Maximum observed concentration
measure: Plasma concentration of multiple oral doses of PHP-303 - Tmax
time frame: Up to 12 weeks
description: Time to reach maximum measured plasma concentration
measure: Plasma concentration of multiple oral doses of PHP-303 - t1/2
time frame: Up to 12 weeks
description: Determination of half-life
arm group label: Experimental
arm group type: Experimental
description: PHP-303, multiple oral dose, up to 5 ascending dose cohorts
arm group label: Placebo
arm group type: Placebo Comparator
description: Placebo, multiple oral dose, up to 5 ascending dose cohorts
intervention type: Drug
intervention name: PHP-303
description: Investigational drug
arm group label: Experimental
intervention type: Other
intervention name: Placebo
description: Matching placebo
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Andrew Nicholls, MD, PhD
role: Study Chair
affiliation: pH Pharma Inc
facility: 
country: United States
responsible party type: Sponsor
mesh term: Overweight