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/NCT06025396</url>
    </required_header>
    <id_info>
      <org_study_id>TMP-301-HNV-101</org_study_id>
      <secondary_id>U01DA057118</secondary_id>
      <nct_id>NCT06025396</nct_id>
    </id_info>
    <brief_title>Multiple Ascending Dose Study of TMP-301 in Healthy Subjects</brief_title>
    <official_title>A Phase 1, Randomized, Placebo-Controlled, Multiple Ascending Dose (MAD) Study To Evaluate The Safety, Tolerability, and Pharmacokinetics of TMP-301 in Healthy Subjects</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Tempero Bio, Inc.</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>National Institute on Drug Abuse (NIDA)</agency>
        <agency_class>NIH</agency_class>
      </collaborator>
    </sponsors>
    <source>Tempero Bio, Inc.</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>
        A PHASE 1, RANDOMIZED, PLACEBO CONTROLLED, MULTIPLE ASCENDING DOSE (MAD) STUDY TO EVALUATE&#xD;
        THE SAFETY, TOLERABILITY, AND PHARMACOKINETICS OF TMP-301 IN HEALTHY SUBJECTS.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This study will be a randomized, double-blind, placebo controlled, fixed sequence, MAD study.&#xD;
        The study will be conducted in a single clinical research unit (CRU). The study will consist&#xD;
        of up to 4 cohorts. Subjects will only participate in 1 cohort.&#xD;
  &#xD;
        Screening will occur within approximately 28 days prior to the first scheduled study drug&#xD;
        administration. Subjects who meet all inclusion criteria and none of the exclusion criteria&#xD;
        and who consent to participation will be admitted to the CRU for baseline evaluations prior&#xD;
        to dosing.&#xD;
  &#xD;
        Subjects will be fasted overnight for 10 hours prior to the morning dose, followed by a 2&#xD;
        hour fast. Subjects are fasted for 2 hours prior to dosing and 2 hours following the evening&#xD;
        dose for the cohort 1 (50 mg bid).&#xD;
  &#xD;
        Subjects will be discharged from the CRU on Day 18. Subjects will return to the CRU on Day 25&#xD;
        for a follow-up visit and EOS procedures.&#xD;
  &#xD;
        Caffeine (100 mg) will be included as probe CYP1A2 substrate in cohort 2 and subsequent&#xD;
        cohorts.&#xD;
  &#xD;
        The maximum duration of subject participation, including Screening, will be approximately 53&#xD;
        days.&#xD;
  &#xD;
        Subjects who terminate the study early will perform follow-up procedures at the time of Early&#xD;
        Termination.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">January 6, 2023</start_date>
    <completion_date type="Anticipated">December 27, 2023</completion_date>
    <primary_completion_date type="Anticipated">December 27, 2023</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>sequential assignment</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Double (Participant, Investigator)</masking>
      <masking_description>Double blind</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)</measure>
      <time_frame>Within each cohort from screening to end of the follow up period up to 25 days</time_frame>
      <description>Occurence of Adverse Events, spontaneously reported and identified through clinical laboratory tests, vital sign measurements, ECG, physical exams and psychiatric assessments.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Plasma levels TMP 301</measure>
      <time_frame>Within each cohort from screening to end of the follow up period up to 25 days</time_frame>
      <description>Repeated collections on Day 1, intermittent samples from Day 2 through Day 13, repeated collections on Day 14, and intermittent samples during washout</description>
    </secondary_outcome>
    <other_outcome>
      <measure>Caffeine and paraxanthine concentration as a marker of CYP1A2 activity</measure>
      <time_frame>Within each cohort, from Pre-dose levels at Day -1 to Day 14.</time_frame>
      <description>Caffeine and paraxanthine concentration</description>
    </other_outcome>
    <other_outcome>
      <measure>Presence of TMP-301 or metabolites in Urine</measure>
      <time_frame>Within each cohort, urine will be collected on Day 1 (0 to 4 hours, 4 to 8 hours, 8 to 12 hours, and 12 - 24 hours) and Day 14 (0 to 4 hours, 4 to 8 hours, 8 to 12 hours, 12 to 24 hours, 24 to 48 hours (Day 15), and 48 - 72 hours (Day 16)).</time_frame>
      <description>Identification of metabolites, if any, detected in urine samples.</description>
    </other_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">32</enrollment>
    <condition>Cocaine Use Disorder</condition>
    <condition>Substance Use Disorders</condition>
    <condition>Healthy Volunteers</condition>
    <arm_group>
      <arm_group_label>Active TMP-301</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Cohort 1= 50mg, capsules form, one capsule - two times per day - total 100mg/day;&#xD;
  Cohort 2= 50mg, capsule form, 1 capsules - one time per day- total 50mg/day&#xD;
  Cohort 3= 50mg, capsule form, 2 capsules - one time per day- total 100mg/day;&#xD;
  Cohort 4 = Dose Titration: 50mg, capsule form, 1 capsules - one time per day - total 50 mg/day - on Days 1-7; and 50 mg, capsule form, 2 capsules - one time per day - total 100mg/day - on Days 8-14;&#xD;
  Each cohort duration is 14 days of dosing</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Placebo</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>Cohort 1= Placebo, capsules form, one capsule - two times per day;&#xD;
  Cohort 2= Placebo, capsule form, 1 capsules - one time per day;&#xD;
  Cohort 3= Placebo, capsule form, 2 capsules - one time per day;&#xD;
  Cohort 4 = Dose Titration: Placebo, capsule form, 1 capsules - one time per day - on Days 1-7; and Placebo, capsule form, 2 capsules - one time per day - on Days 8-14;&#xD;
  Each cohort duration is 14 days of dosing</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>TMP-301</intervention_name>
      <description>Multiple ascending dose active</description>
      <arm_group_label>Active TMP-301</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Placebo</intervention_name>
      <description>Multiple ascending dose comparator</description>
      <arm_group_label>Placebo</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Provision of signed and dated informed consent form (ICF)&#xD;
  &#xD;
            2. Stated willingness to comply with all study procedures and availability for the&#xD;
               duration of the study&#xD;
  &#xD;
            3. Healthy adult male or female&#xD;
  &#xD;
            4. If male, meets one of the following criteria: a) Is able to procreate and agrees to&#xD;
               use one of the accepted contraceptive regimens and not to donate sperm from the first&#xD;
               study drug administration to at least 90 days after the follow-up visit. An acceptable&#xD;
               method of contraception includes one of the following: Abstinence from heterosexual&#xD;
               intercourse, or Male condom with spermicide or male condom with a vaginal spermicide&#xD;
               (gel, foam, or suppository); or b) Is unable to procreate; defined as surgically&#xD;
               sterile (ie, has undergone a vasectomy at least 180 days prior to the first study drug&#xD;
               administration)&#xD;
  &#xD;
            5. If female, meets one of the following criteria: (1) Physiological postmenopausal&#xD;
               status, defined as the following: a) absence of menses for at least 12 months prior to&#xD;
               the first study drug administration (without an alternative medical condition); and b)&#xD;
               Follicle stimulating hormone (FSH) levels ≥ 40 mIU/mL at Screening; Or (2) Surgical&#xD;
               postmenopausal status, defined as the following: a) bilateral oophorectomy,&#xD;
               salpingectomy, or tubal ligation; hysterectomy&#xD;
  &#xD;
            6. Aged at least 18 years but not older than 59 years, inclusive, at the time of informed&#xD;
               consent&#xD;
  &#xD;
            7. Body mass index (BMI) within 18.5 kg/m2 to 32.0 kg/m2, inclusively&#xD;
  &#xD;
            8. Minimum body weight of at least 50.0 kg&#xD;
  &#xD;
            9. Non- or ex smoker (An ex smoker is defined as someone who completely stopped using&#xD;
               nicotine products for at least 90 days prior to the first study drug administration)&#xD;
  &#xD;
           10. Must be willing to abstain from drinking coffee or caffeine containing beverages&#xD;
               during the study, except where part of the study procedures&#xD;
  &#xD;
           11. Has supine blood pressure and pulse rate within the following ranges after 5 minutes&#xD;
               rest: systolic blood pressure 90 to 140 mmHg, diastolic blood pressure 50 to 90 mmHg,&#xD;
               and pulse rate 45 to 90 bpm at Screening and on Day -1&#xD;
  &#xD;
           12. Have no clinically significant diseases captured in the medical history or evidence of&#xD;
               clinically significant findings on the physical examination (including vital signs)&#xD;
               and/or ECG, as determined by an Investigator&#xD;
  &#xD;
           13. Has clinical laboratory test results within the reference ranges of the testing&#xD;
               laboratory, with the exception of results outside the reference ranges that are deemed&#xD;
               not clinically significant by the Investigator (or designee) at Screening and check-in&#xD;
               *&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Female who is lactating&#xD;
  &#xD;
            2. Female who is pregnant according to the pregnancy test at Screening or prior to the&#xD;
               first study drug administration&#xD;
  &#xD;
            3. Female using the following systemic contraceptives: oral, patch or vaginal ring, in&#xD;
               the 28 days prior to the first study drug administration and during the study&#xD;
  &#xD;
            4. Female using hormone replacement therapy in the 28 days prior to the first study drug&#xD;
               administration and during the study&#xD;
  &#xD;
            5. Female using the following systemic contraceptives: injections or implant, or hormone&#xD;
               releasing intrauterine device in the 13 weeks prior to the first study drug&#xD;
               administration and during the study&#xD;
  &#xD;
            6. Drinking excessive amounts of tea, coffee, chocolate, and/or beverage or eating food&#xD;
               containing caffeine (&gt; 2 cups/day)&#xD;
  &#xD;
            7. Use of tobacco or nicotine containing products (including but not limited to;&#xD;
               cigarettes, electronic cigarettes, pipes, cigars, chewing tobacco, nicotine patch, or&#xD;
               nicotine gum) within 90 days prior to the first study drug administration and the&#xD;
               inability to abstain from nicotine containing products until the follow-up visit.&#xD;
  &#xD;
            8. Past or current history of any mental, behavioral, or neurodevelopmental disorder as&#xD;
               defined by the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition&#xD;
               (DSM-5) or significant risk of developing a psychosis (assessed by PRIME screen) or a&#xD;
               personal history of psychotic symptoms (hallucinations or delusions) with or without a&#xD;
               formal psychiatric diagnosis. Subjects with family history of significant mental,&#xD;
               behavioral, or neurodevelopmental disorders unless determined by the Investigator (or&#xD;
               designee) and agreed by the Medical Monitor to be non-clinically significant (NCS)&#xD;
               will be excluded.&#xD;
  &#xD;
            9. History or clinical manifestation of any metabolic, allergic, dermatological, hepatic,&#xD;
               renal, hematological, pulmonary, gastrointestinal, neurological, respiratory, or&#xD;
               endocrine disorder, unless determined by the Investigator (or designee) and agreed by&#xD;
               the Medical Monitor to be NCS&#xD;
  &#xD;
           10. Active or history of cardiovascular or cerebrovascular disease, including&#xD;
               hypertension, angina, ischemic heart disease, transient ischemic attacks, bundle&#xD;
               branch block, evidence of myocardial ischemia, stroke, and peripheral arterial disease&#xD;
               sufficient to cause symptoms and/or require therapy to maintain stable status&#xD;
  &#xD;
           11. History of significant hypersensitivity, intolerance, or allergy to any drug compound,&#xD;
               food, or other substance, unless approved by the Investigator (or designee)&#xD;
  &#xD;
           12. Active neoplastic disease or history of any neoplastic disease within 5 years of&#xD;
               Screening (except for basal or squamous cell carcinoma of the skin or carcinoma in&#xD;
               situ that has been definitely treated with standard of care)&#xD;
  &#xD;
           13. Active infection (eg, sepsis, pneumonia, abscess) or a serious infection (eg,&#xD;
               resulting in hospitalization or requiring parenteral antibiotic treatment) within 6&#xD;
               weeks prior to dosing&#xD;
  &#xD;
           14. History of stomach or intestinal surgery or resection that would potentially alter&#xD;
               absorption and/or excretion of orally administered drugs (uncomplicated appendectomy&#xD;
               and hernia repair will be allowed)&#xD;
  &#xD;
           15. Any of the following at Screening and/or prior to the first study drug administration:&#xD;
  &#xD;
                 1. QT interval corrected for heart rate using Fridericia's method (QTcF) &gt; 450 ms&#xD;
                    confirmed by repeat measurement&#xD;
  &#xD;
                 2. QRS duration &gt; 110 ms confirmed by confirmed by repeat measurement&#xD;
  &#xD;
                 3. PR interval &gt; 220 ms confirmed by repeat measurement&#xD;
  &#xD;
                 4. Findings which would make QTc measurements difficult or QTc data uninterpretable&#xD;
  &#xD;
                 5. History of additional risk factors for torsades de pointe (eg, heart failure,&#xD;
                    hypokalemia, family history of long QT syndrome)&#xD;
  &#xD;
           16. Maintenance therapy with any drug or significant history of drug dependency or alcohol&#xD;
               abuse (&gt; 3 units of alcohol per day, intake of excessive alcohol, acute or chronic)&#xD;
  &#xD;
           17. Positive test result for alcohol, cotinine, and/or drugs of abuse at Screening or&#xD;
               prior to the first drug administration&#xD;
  &#xD;
           18. Positive screening results to HIV Ag/Ab combo, hepatitis B surface antigen or&#xD;
               hepatitis C virus tests&#xD;
  &#xD;
           19. Any other clinically significant abnormalities in laboratory test results at Screening&#xD;
               that would, in the opinion of an Investigator, increase the subject's risk of&#xD;
               participation, jeopardize complete participation in the study, or compromise&#xD;
               interpretation of study data&#xD;
  &#xD;
           20. Intake of an IP in the 28 days prior to the first study drug administration&#xD;
  &#xD;
           21. Use of any prescription drugs in the 28 days prior to the first study drug&#xD;
               administration, that in the opinion of an Investigator would put into question the&#xD;
               status of the participant as healthy&#xD;
  &#xD;
           22. Use of St. John's wort in the 28 days prior to the first study drug administration and&#xD;
               during the study&#xD;
  &#xD;
           23. Consumption of any foods or beverages which alter CYP1A2 activity, e.g., barbecued&#xD;
               food or cruciferous vegetables, such as broccoli and cauliflower, within 14 days prior&#xD;
               to (first) check-in (a list of prohibited foods will be provided to subjects)&#xD;
  &#xD;
           24. Consumption of any foods or beverages containing Seville-type oranges, grapefruit, or&#xD;
               poppy seeds within 7 days prior to (first) check-in&#xD;
  &#xD;
           25. Receipt of blood products within 2 months prior to check-in&#xD;
  &#xD;
           26. Donation of 1 unit of blood to American Red Cross or equivalent organization or&#xD;
               donation of over 500 mL of blood in the 56 days prior to the first study drug&#xD;
               administration&#xD;
  &#xD;
           27. Donation of plasma in the 7 days prior to the first study drug administration&#xD;
  &#xD;
           28. Poor peripheral venous access&#xD;
  &#xD;
           29. History or significant hypersensitivity to TMP301 or any related products (including&#xD;
               excipients of the formulations) as well as severe hypersensitivity reactions (like&#xD;
               angioedema) to any drugs&#xD;
  &#xD;
           30. Subjects who, in the opinion of the Investigator (or designee; including input from&#xD;
               subjects' general practitioner, as applicable), should not participate in this study&#xD;
  &#xD;
           31. Subject hospitalized for any reason in a period of 30 days before the start of the&#xD;
               study&#xD;
  &#xD;
           32. Subjects who are investigational site staff members or directly involved in the&#xD;
               conduct of the study and their family members or subjects who are employed by the&#xD;
               Sponsor&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>59 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Dan Meyers, MD</last_name>
      <role>Study Director</role>
      <affiliation>CMO, Tempero Bio</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Dan Meyers, MD</last_name>
      <phone>978-501-1409</phone>
      <email>dan.meyers@aditumbio.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Chris Resburg</last_name>
      <phone>510-626-5251</phone>
      <email>chris.resburg@aditumbio.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Altasciences</name>
        <address>
          <city>Overland Park</city>
          <state>Kansas</state>
          <zip>66212</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Debra Kelsh, MD</last_name>
        <phone>913-696-1601</phone>
        <email>contact@altasciences.com</email>
      </contact>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 21, 2023</study_first_submitted>
    <study_first_submitted_qc>August 29, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 6, 2023</study_first_posted>
    <last_update_submitted>September 13, 2023</last_update_submitted>
    <last_update_submitted_qc>September 13, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>drug addiction</keyword>
    <keyword>cocaine use disorder</keyword>
    <keyword>cocaine dependance</keyword>
    <keyword>TMP-301</keyword>
    <keyword>cocaine use</keyword>
    <keyword>CUD</keyword>
    <keyword>drug abuse</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Substance-Related Disorders</mesh_term>
    </condition_browse>
    <!-- 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/NCT06025396
  org study id: TMP-301-HNV-101
  secondary id: U01DA057118
  nct id: NCT06025396
  lead sponsor: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: Yes
  is fda regulated device: No
  A PHASE 1, RANDOMIZED, PLACEBO CONTROLLED, MULTIPLE ASCENDING DOSE (MAD) STUDY TO EVALUATE
        THE SAFETY, TOLERABILITY, AND PHARMACOKINETICS OF TMP-301 IN HEALTHY SUBJECTS.
  This study will be a randomized, double-blind, placebo controlled, fixed sequence, MAD study.
        The study will be conducted in a single clinical research unit (CRU). The study will consist
        of up to 4 cohorts. Subjects will only participate in 1 cohort.
  
        Screening will occur within approximately 28 days prior to the first scheduled study drug
        administration. Subjects who meet all inclusion criteria and none of the exclusion criteria
        and who consent to participation will be admitted to the CRU for baseline evaluations prior
        to dosing.
  
        Subjects will be fasted overnight for 10 hours prior to the morning dose, followed by a 2
        hour fast. Subjects are fasted for 2 hours prior to dosing and 2 hours following the evening
        dose for the cohort 1 (50 mg bid).
  
        Subjects will be discharged from the CRU on Day 18. Subjects will return to the CRU on Day 25
        for a follow-up visit and EOS procedures.
  
        Caffeine (100 mg) will be included as probe CYP1A2 substrate in cohort 2 and subsequent
        cohorts.
  
        The maximum duration of subject participation, including Screening, will be approximately 53
        days.
  
        Subjects who terminate the study early will perform follow-up procedures at the time of Early
        Termination.
  allocation: Randomized
  intervention model: Sequential Assignment
  intervention model description: sequential assignment
  primary purpose: Treatment
  masking: Double (Participant, Investigator)
  masking description: Double blind
  measure: Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)
  time frame: Within each cohort from screening to end of the follow up period up to 25 days
  description: Occurence of Adverse Events, spontaneously reported and identified through clinical laboratory tests, vital sign measurements, ECG, physical exams and psychiatric assessments.
  measure: Plasma levels TMP 301
  time frame: Within each cohort from screening to end of the follow up period up to 25 days
  description: Repeated collections on Day 1, intermittent samples from Day 2 through Day 13, repeated collections on Day 14, and intermittent samples during washout
  measure: Caffeine and paraxanthine concentration as a marker of CYP1A2 activity
  time frame: Within each cohort, from Pre-dose levels at Day -1 to Day 14.
  description: Caffeine and paraxanthine concentration
  measure: Presence of TMP-301 or metabolites in Urine
  time frame: Within each cohort, urine will be collected on Day 1 (0 to 4 hours, 4 to 8 hours, 8 to 12 hours, and 12 - 24 hours) and Day 14 (0 to 4 hours, 4 to 8 hours, 8 to 12 hours, 12 to 24 hours, 24 to 48 hours (Day 15), and 48 - 72 hours (Day 16)).
  description: Identification of metabolites, if any, detected in urine samples.
  arm group label: Active TMP-301
  arm group type: Experimental
  description: Cohort 1= 50mg, capsules form, one capsule - two times per day - total 100mg/day;
  Cohort 2= 50mg, capsule form, 1 capsules - one time per day- total 50mg/day
  Cohort 3= 50mg, capsule form, 2 capsules - one time per day- total 100mg/day;
  Cohort 4 = Dose Titration: 50mg, capsule form, 1 capsules - one time per day - total 50 mg/day - on Days 1-7; and 50 mg, capsule form, 2 capsules - one time per day - total 100mg/day - on Days 8-14;
  Each cohort duration is 14 days of dosing
  arm group label: Placebo
  arm group type: Placebo Comparator
  description: Cohort 1= Placebo, capsules form, one capsule - two times per day;
  Cohort 2= Placebo, capsule form, 1 capsules - one time per day;
  Cohort 3= Placebo, capsule form, 2 capsules - one time per day;
  Cohort 4 = Dose Titration: Placebo, capsule form, 1 capsules - one time per day - on Days 1-7; and Placebo, capsule form, 2 capsules - one time per day - on Days 8-14;
  Each cohort duration is 14 days of dosing
  intervention type: Drug
  intervention name: TMP-301
  description: Multiple ascending dose active
  arm group label: Active TMP-301
  intervention type: Drug
  intervention name: Placebo
  description: Multiple ascending dose comparator
  arm group label: Placebo
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 59 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Dan Meyers, MD
  role: Study Director
  affiliation: CMO, Tempero Bio
  last name: Dan Meyers, MD
  phone: 978-501-1409
  email: dan.meyers@aditumbio.com
  last name: Chris Resburg
  phone: 510-626-5251
  email: chris.resburg@aditumbio.com
  facility: 
  status: Recruiting
  contact: 
  country: United States
  responsible party type: Sponsor
  mesh term: Substance-Related Disorders