<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/NCT03798236</url>
  </required_header>
  <id_info>
    <org_study_id>PBF-1650CT-01</org_study_id>
    <nct_id>NCT03798236</nct_id>
  </id_info>
  <brief_title>Study to Assess the Safety and Tolerability of PBF-1650 in Healthy Volunteers.</brief_title>
  <acronym>ADENOIMMUNE</acronym>
  <official_title>Randomized, Double Blind, Placebo Controlled &quot;First-in-human&quot; Study to Assess the Safety and Tolerability of Single Ascending Oral Doses of PBF-1650 (40 mg, 80 mg, 120 and 240 mg) in Healthy Young Male Volunteers.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Palobiofarma SL</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Clínica Universidad de Navarra</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Palobiofarma SL</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>
      Single center, randomized, double-blind, placebo-controlled clinical study to assess the&#xD;
      safety and tolerability of PBF-1650 in order to obtain the Maximum Tolerated Dose (MTD).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The clinical trial will be a dose escalation study without therapeutic benefit, in which&#xD;
      PBF-1650 will be administered as single oral ascending- dose to healthy young male&#xD;
      volunteers. Up to four different rising doses will be tested (40 mg, 80 mg, 120 and 240 mg)&#xD;
      in groups/cohorts of 8 participants. Thus, four groups/cohorts will participate. For each&#xD;
      dose level / group, the participants will be randomized to active or placebo with 2&#xD;
      participants being randomly assigned to placebo and 6 to the active drug. First, one&#xD;
      volunteer will receive active drug (subgroup 1); after at least 48h of safety and&#xD;
      tolerability assessment a second subgroup of 3 volunteers will receive 2 active drug and 1&#xD;
      placebo; after at least another 48h of safety and tolerability parameters assessment a third&#xD;
      subgroup of 4 volunteers will receive 3 active drug and 1 placebo. After evaluation of safety&#xD;
      parameters of corresponding dose level, the process will replicate one week afterwards in the&#xD;
      following dosages.&#xD;
&#xD;
      The pharmacokinetics profile of PBF-1650 after single oral dose administration of the four&#xD;
      dose levels will be also assessed.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 10, 2018</start_date>
  <completion_date type="Actual">May 31, 2019</completion_date>
  <primary_completion_date type="Actual">March 30, 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>
    <intervention_model_description>Single center, randomized, double-blind, placebo-controlled clinical study.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Adverse events</measure>
    <time_frame>7 Days</time_frame>
    <description>Adverse Events will be qualified according to the definitions and values stated in CTCAE V04 v4)</description>
  </primary_outcome>
  <number_of_arms>5</number_of_arms>
  <enrollment type="Actual">32</enrollment>
  <condition>Psoriasis</condition>
  <arm_group>
    <arm_group_label>PBF-1650 40mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>PBF-1650 80mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>PBF-1650 120mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>PBF-1650 240mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>PBF-1650 oral capsules</intervention_name>
    <description>Adenosine A3 receptor (AA3R) antagonist</description>
    <arm_group_label>PBF-1650 120mg</arm_group_label>
    <arm_group_label>PBF-1650 240mg</arm_group_label>
    <arm_group_label>PBF-1650 40mg</arm_group_label>
    <arm_group_label>PBF-1650 80mg</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo oral capsule</intervention_name>
    <description>solid microcrystalline cellulose</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy male subjects, 18-45 years (inclusive) of age at the time of enrollment.&#xD;
&#xD;
          -  Males should agree to abstain from sexual intercourse with a female partner or agree&#xD;
             to use a condom with spermicide, in addition to having their female partner use some&#xD;
             contraceptive measures as oral contraceptive drugs, intrauterine hormonal&#xD;
             contraception, or cervical caps until 28 days post-administration.&#xD;
&#xD;
          -  Clinically acceptable blood pressure and pulse rate in supine and standing position&#xD;
             (SBP between 140-100 mm Hg/ DBP between 90-50 mm Hg / HR between 100-50 bpm). Blood&#xD;
             pressure and pulse will be measured after a minimum of 3 minutes of resting.&#xD;
&#xD;
          -  Body weight within normal range (Quetelet's index between 19 and 26) expressed as&#xD;
             weight (kg) / height (m2).&#xD;
&#xD;
          -  Able to understand the nature of the study and comply with all their requirements.&#xD;
&#xD;
          -  Free acceptance to participate in the study by obtains signed informed consent form&#xD;
             approved by the Ethics Committee (CEIm).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of serious adverse reactions or hypersensitivity to any drug.&#xD;
&#xD;
          -  Presence or history of allergies requiring acute or chronic treatment (except seasonal&#xD;
             allergic rhinitis).&#xD;
&#xD;
          -  Background or clinical evidence of chronic diseases.&#xD;
&#xD;
          -  Acute illness two weeks before drug administration.&#xD;
&#xD;
          -  Having undergone major surgery during the previous 6 months.&#xD;
&#xD;
          -  Smokers (refrained from any tobacco usage, including smokeless tobacco, nicotine&#xD;
             patches, etc., for 6 months prior to the administration of the study medication).&#xD;
&#xD;
          -  History of alcohol dependence or drug abuse in the last 5 years or daily consumption&#xD;
             of alcohol &gt; 40 g or high consumption of stimulating beverages (&gt; 5 coffees, teas or&#xD;
             coca cola drinks/ day).&#xD;
&#xD;
          -  Abnormal physical findings of clinical significance at the screening examination or&#xD;
             baseline which would interfere with the objectives of the study.&#xD;
&#xD;
          -  Need of any prescription medication within 14 days prior to the administration of the&#xD;
             investigational drug and non-prescription medication or herbal medicines within 7 days&#xD;
             prior to the administration of the drug. Paracetamol (acetaminophen) is allowed, at&#xD;
             doses up to 1 g daily, at the investigator discretion.&#xD;
&#xD;
          -  Participation in other clinical trials during the previous 90 days in which an&#xD;
             investigational drug or a commercially available drug was tested.&#xD;
&#xD;
          -  Having donated blood during 3 months' period before inclusion in the study.&#xD;
&#xD;
          -  Existence of any surgical or medical condition which might interfere with the&#xD;
             absortion, distribution, metabolism or excretion of the drug, i.e. impaired renal or&#xD;
             hepatic function, diabetes mellitus, cardiovascular abnormalities, chronic symptoms of&#xD;
             pronounced constipation or diarrhea or conditions associated with total or partial&#xD;
             obstruction of the urinary tract&#xD;
&#xD;
          -  12 lead ECG obtained at screening with PR ≥ 220 msec, QRS ≥120 msec and QTc ≥ 440&#xD;
             msec, bradychardia (&lt;50 bpm) or clinically significant minor ST wave changes or any&#xD;
             other abnormal changes on the screening ECG that would interfere with measurement of&#xD;
             the QT interval.&#xD;
&#xD;
          -  Symptoms of a significant somatic or mental illness in the four-week period preceding&#xD;
             drug administration.&#xD;
&#xD;
          -  History of hepatitis HBV and / or HCV and / or positive serology results, which&#xD;
             indicate the presence of hepatitis B surface antigen and / or detectable HCV&#xD;
             ribonucleic acid (RNA).&#xD;
&#xD;
          -  Positive results from the HIV serology.&#xD;
&#xD;
          -  Clinically significant abnormal laboratory values (as determined by the Principal&#xD;
             Investigator) at the screening evaluation.&#xD;
&#xD;
          -  Positive results of the drugs at screening period or the day before starting treatment&#xD;
             period. A minimum list of 6 drugs will be screened for inclusion: Amphetamines,&#xD;
             Cocaine, Ethanol, Opiates, Cannabinoids and Benzodiazepines (positive results may be&#xD;
             repeated at the discretion of the Principal Investigator).&#xD;
&#xD;
          -  Known hypersensitivity to the study drug or the composition of the galenical form.&#xD;
&#xD;
          -  History of psychiatric diseases or epileptic seizures.&#xD;
&#xD;
          -  Pill swallowing difficulties.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Clinica Universidad de Navarra</name>
      <address>
        <city>Pamplona</city>
        <state>Navarra</state>
        <zip>31007</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>January 7, 2019</study_first_submitted>
  <study_first_submitted_qc>January 7, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 9, 2019</study_first_posted>
  <last_update_submitted>June 28, 2020</last_update_submitted>
  <last_update_submitted_qc>June 28, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 30, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Adenosine A3 receptor antagonist</keyword>
  <keyword>autoimmune diseases</keyword>
  <keyword>Immune modulator</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Psoriasis</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/NCT03798236
org study id: PBF-1650CT-01
nct id: NCT03798236
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Single center, randomized, double-blind, placebo-controlled clinical study to assess the
      safety and tolerability of PBF-1650 in order to obtain the Maximum Tolerated Dose (MTD).
The clinical trial will be a dose escalation study without therapeutic benefit, in which
      PBF-1650 will be administered as single oral ascending- dose to healthy young male
      volunteers. Up to four different rising doses will be tested (40 mg, 80 mg, 120 and 240 mg)
      in groups/cohorts of 8 participants. Thus, four groups/cohorts will participate. For each
      dose level / group, the participants will be randomized to active or placebo with 2
      participants being randomly assigned to placebo and 6 to the active drug. First, one
      volunteer will receive active drug (subgroup 1); after at least 48h of safety and
      tolerability assessment a second subgroup of 3 volunteers will receive 2 active drug and 1
      placebo; after at least another 48h of safety and tolerability parameters assessment a third
      subgroup of 4 volunteers will receive 3 active drug and 1 placebo. After evaluation of safety
      parameters of corresponding dose level, the process will replicate one week afterwards in the
      following dosages.

      The pharmacokinetics profile of PBF-1650 after single oral dose administration of the four
      dose levels will be also assessed.
allocation: Randomized
intervention model: Sequential Assignment
intervention model description: Single center, randomized, double-blind, placebo-controlled clinical study.
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Number of Adverse events
time frame: 7 Days
description: Adverse Events will be qualified according to the definitions and values stated in CTCAE V04 v4)
arm group label: PBF-1650 40mg
arm group type: Experimental
arm group label: PBF-1650 80mg
arm group type: Experimental
arm group label: PBF-1650 120mg
arm group type: Experimental
arm group label: PBF-1650 240mg
arm group type: Experimental
arm group label: Placebo
arm group type: Placebo Comparator
intervention type: Drug
intervention name: PBF-1650 oral capsules
description: Adenosine A3 receptor (AA3R) antagonist
arm group label: PBF-1650 120mg
arm group label: PBF-1650 240mg
arm group label: PBF-1650 40mg
arm group label: PBF-1650 80mg
intervention type: Drug
intervention name: Placebo oral capsule
description: solid microcrystalline cellulose
arm group label: Placebo
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Spain
responsible party type: Sponsor
mesh term: Psoriasis