<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/NCT03796910</url>
  </required_header>
  <id_info>
    <org_study_id>SPR720-101</org_study_id>
    <nct_id>NCT03796910</nct_id>
  </id_info>
  <brief_title>A Study of the Safety, Tolerability, and Pharmacokinetics of SPR720 in Healthy Volunteers</brief_title>
  <official_title>A Two-part, Randomized, Double-blind, Placebo-controlled, First-In-Human, Phase I Study of the Safety, Tolerability, and Pharmacokinetics of SPR720 Following Administration of Single and Multiple Ascending Oral Doses in Healthy Volunteers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Spero Therapeutics</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Simbec Research</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Spero Therapeutics</source>
  <oversight_info>
    <has_dmc>Yes</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>
      The purpose of the study is to evaluate the safety, tolerability, and pharmacokinetics (PK)&#xD;
      following single and multiple ascending dose administration of SPR720 administered orally in&#xD;
      healthy volunteers.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a single-center, phase I, randomized, double-blind, placebo-controlled, first-in-man&#xD;
      study. Up to 120 healthy volunteers may be enrolled in this 2-part, multi-cohort study. In&#xD;
      both Part 1 and Part 2, sequential cohorts will be exposed to increasing doses of SPR720.&#xD;
      Each cohort will enrol 8 subjects, randomized (3:1) to receive SPR720 (6 subjects) or placebo&#xD;
      (2 subjects). Each subject will be assigned to only one cohort.&#xD;
&#xD;
      In Part 1 single ascending dose (SAD):&#xD;
&#xD;
      A single oral dose of SPR720 (n=6) or placebo (n=2) will be administered to 8 subjects at an&#xD;
      initial dose level of 100 mg. Additional cohorts of 8 subjects will be enrolled to&#xD;
      investigate increasing doses of SPR720 ranging from 250 mg to 3000 mg. All subjects will&#xD;
      receive SPR720 (or placebo) by oral administration in the fasted state. One Part 1 cohort&#xD;
      (the Food Effect Cohort) will receive an additional single dose of SPR720 (or placebo) in the&#xD;
      fed state.&#xD;
&#xD;
      Part 2 multiple ascending dose (MAD):&#xD;
&#xD;
      SPR720 (or placebo) will be administered to approximately 3 planned dose cohorts of 8&#xD;
      subjects each. Subjects will receive SPR720 (or placebo) orally once daily for 7 (or 14)&#xD;
      consecutive days starting with a planned initial dose of 500 mg. Additional cohorts of 8&#xD;
      subjects will be enrolled to investigate repeated daily doses of SPR720 ranging from 1000 mg&#xD;
      to 1500 mg.&#xD;
&#xD;
      For both Part 1 and Part 2, a Safety Monitoring Group (SMG) will review cumulative safety and&#xD;
      PK data from each cohort before proceeding to the next cohort/dose level. Doses to be&#xD;
      evaluated in each subsequent cohort may be modified by the SMG based on review of safety and&#xD;
      PK data from preceding cohorts. Part 2 will run concurrent with Part 1 and will be initiated&#xD;
      following SMG review of safety and PK data for the corresponding Part 1 dose level cohort.&#xD;
&#xD;
      Part 1 will be conducted in up to 64 subjects (8 planned dose cohorts of 8 subjects each).&#xD;
      Part 2 will be conducted in up to 24 subjects (3 planned dose cohorts of 8 subjects each);&#xD;
      additional cohorts of 8 subjects each (up to 16 additional subjects) may be enrolled in&#xD;
      either Part if further investigation of SPR720 is required.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 18, 2018</start_date>
  <completion_date type="Actual">September 24, 2019</completion_date>
  <primary_completion_date type="Actual">September 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>
    <intervention_model_description>Randomized, double-blind, placebo-controlled, single and multiple ascending dose (SAD and MAD) trial</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    <masking_description>Subjects will be randomized in a 3:1 ratio to receive SPR720 or placebo. The randomization code will produced by Simbec using the PROC PLAN procedure of SAS® version 9.3 or higher. The randomization code will include 2 dose-leaders (1 active:1 placebo) in each cohort who will be randomized prior to the remainder of the cohort. The allocation to SPR720 or placebo will be performed using a block randomization algorithm.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Treatment emergent adverse events assessments after single and multiple dose administration at baseline and repeatedly until study completion [Safety and Tolerability]</measure>
    <time_frame>Day 1 through last follow-up visit (5-7 days after last dose)</time_frame>
    <description>Incidence and severity of AEs</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Assessment of Pharmacokinetic Parameter (plasma): Cmax measurement</measure>
    <time_frame>From Day 1 pre-dose to 48 hours post last dose</time_frame>
    <description>Maximum concentration of study drug in plasma</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of Pharmacokinetic Parameter (plasma): CmaxSS measurement</measure>
    <time_frame>From Day 1 pre-dose to 48 hours post last dose</time_frame>
    <description>Maximum concentration of study drug in plasma at steady state</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of Pharmacokinetic Parameter (plasma): CminSS</measure>
    <time_frame>From Day 1 pre-dose to 48 hours post last dose</time_frame>
    <description>Lowest concentration of study drug in a dosing interval in plasma</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of Pharmacokinetic Parameter (plasma): Ctrough</measure>
    <time_frame>From Day 1 pre-dose to 48 hours post last dose</time_frame>
    <description>Concentration of study drug at the end of the dosing interval in plasma</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of Pharmacokinetic Parameter (plasma): CavSS</measure>
    <time_frame>From Day 1 pre-dose to 48 hours post last dose</time_frame>
    <description>Average concentration of study drug in plasma during a dosing interval</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of Pharmacokinetic Parameter (plasma): Tmax</measure>
    <time_frame>From Day 1 pre-dose to 48 hours post last dose</time_frame>
    <description>The time to maximum observed concentration of study drug in plasma</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of Pharmacokinetic Parameter (plasma): kel</measure>
    <time_frame>From Day 1 pre-dose to 48 hours post last dose</time_frame>
    <description>Elimination rate constant of study drug in plasma</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of Pharmacokinetic Parameter (plasma): t1/2</measure>
    <time_frame>From Day 1 pre-dose to 48 hours post last dose</time_frame>
    <description>Terminal elimination half-life of study drug in plasma</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of Pharmacokinetic Parameter (plasma): AUC0-24</measure>
    <time_frame>From Day 1 pre-dose to 48 hours post last dose</time_frame>
    <description>Area under the concentration-time curve (AUC) of study drug in plasma from 0 to 24 hours post dose (dose escalation)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of Pharmacokinetic Parameter (plasma): AUC0-tau</measure>
    <time_frame>From Day 1 pre-dose to 48 hours post last dose</time_frame>
    <description>Area under the concentration-time curve (AUC) from 0 to tau, where tau is the dosing interval (multiple dose only) of study drug in plasma</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of Parameter (plasma): AUC0-t</measure>
    <time_frame>From Day 1 pre-dose to 48 hours post last dose</time_frame>
    <description>Area under the concentration-time curve (AUC) of study drug in plasma from the time of dosing to the time of the last measurable concentration</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of Pharmacokinetic Parameter (plasma): AUC0-inf</measure>
    <time_frame>From Day 1 pre-dose to 48 hours post last dose</time_frame>
    <description>AUC extrapolated to infinity of study drug in plasma</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of Parameter (plasma): AUC%extrapolated</measure>
    <time_frame>From Day 1 pre-dose to 48 hours post last dose</time_frame>
    <description>Residual area of study drug in plasma</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of Pharmacokinetic Parameter (plasma): Degree of fluctuation</measure>
    <time_frame>From Day 1 pre-dose to 48 hours post last dose</time_frame>
    <description>(Cmax-Cmin)/Cavss of study drug in plasma</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of Pharmacokinetic Parameter (plasma): Swing</measure>
    <time_frame>From Day 1 pre-dose to 48 hours post last dose</time_frame>
    <description>(Cmaxss-Cminss)/Cminss of study drug in plasma</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of Pharmacokinetic Parameter (urine): SPR719</measure>
    <time_frame>From Day 1 pre-dose to 24 hours post last dose</time_frame>
    <description>amount of SPR719 excreted in urine</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">96</enrollment>
  <condition>Healthy Volunteers</condition>
  <arm_group>
    <arm_group_label>SPR720 for SAD</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>6 out of 8 subjects per cohort will be randomized to receive SPR720</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo for SAD</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>2 out of 8 subjects per cohort will be randomized to receive placebo</description>
  </arm_group>
  <arm_group>
    <arm_group_label>SPR720 for MAD</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>6 out of 8 subjects per cohort will be randomized to receive SPR720</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo for MAD</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>2 out of 8 subjects per cohort will be randomized to receive placebo</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>SPR720 for SAD</intervention_name>
    <description>Healthy subjects meeting eligibility criteria will be sequentially randomized to each dose cohort (up to 8 dose ascending cohorts) to receive either SPR720 or placebo. The study drug (SPR720 or placebo) will be administered as a single dose.</description>
    <arm_group_label>SPR720 for SAD</arm_group_label>
    <other_name>SPR720 Oral Capsule</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo for SAD</intervention_name>
    <description>Healthy subjects meeting eligibility criteria will be sequentially randomized to each dose cohort (up to 8 dose ascending cohorts) to receive either SPR720 or placebo. The study drug (SPR720 or placebo) will be administered orally as a single dose.</description>
    <arm_group_label>Placebo for SAD</arm_group_label>
    <other_name>Placebo oral Capsule</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>SPR720 for MAD</intervention_name>
    <description>Healthy subjects meeting eligibility criteria will be sequentially randomized to each dose cohort (up to 3 cohorts) to receive either SPR720 or placebo. The study drug (SPR720 or placebo) will be administered orally for a total of 7 (or 14) days of dosing.</description>
    <arm_group_label>SPR720 for MAD</arm_group_label>
    <other_name>SPR720 Oral Capsule</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo for MAD</intervention_name>
    <description>Healthy subjects meeting eligibility criteria will be sequentially randomized to each dose cohort (up to 3 cohorts) to receive either SPR720 or placebo. The study drug (SPR720 or placebo) will be administered orally for a total of 7 (or 14) days of dosing</description>
    <arm_group_label>Placebo for MAD</arm_group_label>
    <other_name>Placebo Oral Capsule</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        KEY INCLUSION CRITERIA:&#xD;
&#xD;
          1. Healthy adult male or female of non-childbearing potential,18 to 55 or ≥ 65 years of&#xD;
             age (inclusive) at the time of screening;&#xD;
&#xD;
          2. Body mass index (BMI) ≥ 18.5 and ≤ 32 (kg/m2) and weight between 55.0 and 100.0 kg&#xD;
             (inclusive). BMI = body weight (kg) / [height (m)]2 (subjects 18 to 55 years of age);&#xD;
             Body mass index (BMI) ≥ 18 and ≤ 32 (kg/m2) and weight between 50.0 and 100.0 kg&#xD;
             (inclusive). BMI = body weight (kg) / [height (m)]2 (subjects 65 years of age and&#xD;
             older);&#xD;
&#xD;
          3. Medically healthy without clinically significant (CS) abnormalities as assessed by the&#xD;
             Principal Investigator (or deputy) based on the following at screening assessments:&#xD;
&#xD;
             a. Detailed medical history, complete physical examination, vital signs, 12-lead ECG,&#xD;
             hematology, blood chemistry and urinalysis laboratory variables;&#xD;
&#xD;
          4. Willing and able to provide written informed consent;&#xD;
&#xD;
          5. Willing and able to comply with all study assessments and adhere to the protocol&#xD;
             schedule;&#xD;
&#xD;
          6. If female, must be non-lactating and be of non-childbearing potential;&#xD;
&#xD;
          7. If male, must agree to not donate sperm for 90 days after the last dose of study drug&#xD;
             and, if engaging in vaginal sexual intercourse with a female partner of childbearing&#xD;
             potential, agree to use a condom with spermicide in addition to requesting the female&#xD;
             partner use a highly effective method of birth control (e.g. intrauterine device,&#xD;
             diaphragm with spermicide, hormonal contraceptives) throughout the duration of the&#xD;
             study and for 90 days after the last dose of study drug. This criterion also applies&#xD;
             to males who have had a vasectomy.&#xD;
&#xD;
        KEY EXCLUSION CRITERIA:&#xD;
&#xD;
          1. History or presence of any clinically significant disease state in any body system, as&#xD;
             assessed by the Principal Investigator (or deputy), that may affect the outcome of the&#xD;
             study or compromise the safety of the subject;&#xD;
&#xD;
          2. Subjects who do not have suitable veins for multiple venipunctures/cannulation as&#xD;
             assessed by the Principal Investigator (or deputy) at screening;&#xD;
&#xD;
          3. Subjects who are unable to demonstrate the ability to swallow a &quot;dummy&quot; capsule (i.e.,&#xD;
             an empty gelatin capsule) of the size proposed for administration in a particular&#xD;
             cohort/dose level;&#xD;
&#xD;
          4. History of any clinically significant acute illness or surgery within the previous&#xD;
             three months;&#xD;
&#xD;
          5. History of chronic gastritis, gastrointestinal tract disorders, including Clostridium&#xD;
             difficile infection; chronic liver or biliary disease;&#xD;
&#xD;
          6. History of seizure disorder, except for febrile seizures in childhood;&#xD;
&#xD;
          7. Documented history of significant hypersensitivity reaction or anaphylaxis to any&#xD;
             medication;&#xD;
&#xD;
          8. History of significant allergic disease requiring treatment; allergic rhinitis (hay&#xD;
             fever) is allowed unless it has required medication for treatment or prophylaxis&#xD;
             within the 14 days prior to randomization;&#xD;
&#xD;
          9. Clinically significant screening ECG findings as assessed by the investigator;&#xD;
&#xD;
         10. Subject or family history of cardiac arrhythmia, prolonged QT syndrome, Torsades de&#xD;
             pointes, unexplained sudden cardiac arrest or syncope, sick sinus syndrome or other&#xD;
             clinically relevant cardiac disease;&#xD;
&#xD;
         11. Clinically significant abnormalities in vital signs at screening and/or prior to&#xD;
             randomization;&#xD;
&#xD;
         12. Clinically significant screening laboratory abnormalities;&#xD;
&#xD;
         13. History or suspicion of routine or chronic drug or alcohol abuse or dependence within&#xD;
             1 year prior to randomization, and/or positive urine drug testing at screening or&#xD;
             check-in (Day -1);&#xD;
&#xD;
         14. Reported consumption of alcoholic beverages &gt; 21 units per week on average (1 unit =&#xD;
             12 oz or 360 mL of beer; 5 oz or 150 mL of wine; 1.5 oz or 45 mL of distilled&#xD;
             spirits); positive alcohol urine test at check in (Day -1);&#xD;
&#xD;
         15. Use of tobacco, nicotine, or nicotine replacement products within 30 days prior to&#xD;
             randomization or planned use during the study; positive carbon monoxide breath test at&#xD;
             check in (Day -1);&#xD;
&#xD;
         16. Use of any prescription or non-prescription medication, including herbal products,&#xD;
             vitamins and vaccines within 7 days (or 5 half-lives whichever is longer) prior to&#xD;
             randomization or planned use during the study period;&#xD;
&#xD;
         17. Consumption of grapefruit or grapefruit-containing products in the 7 days prior to&#xD;
             randomization;&#xD;
&#xD;
         18. Donation of more than 500 mL of blood or plasma within 30 days prior to randomization,&#xD;
             or loss of whole blood of more than 500 mL within 30 days prior to randomization, or&#xD;
             receipt of a blood transfusion within 1 year of study enrolment.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Annelize Koch, MBChB</last_name>
    <role>Principal Investigator</role>
    <affiliation>Simbec Research</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Simbec Research, Ltd.</name>
      <address>
        <city>Merthyr Tydfil,</city>
        <state>Mid Glamorgan</state>
        <zip>CF48 4DR</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>October 2019</verification_date>
  <study_first_submitted>January 3, 2019</study_first_submitted>
  <study_first_submitted_qc>January 7, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 8, 2019</study_first_posted>
  <last_update_submitted>October 24, 2019</last_update_submitted>
  <last_update_submitted_qc>October 24, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">October 28, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>safety</keyword>
  <keyword>tolerability</keyword>
  <keyword>pharmacokinetics</keyword>
  <keyword>SPR720</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03796910
org study id: SPR720-101
nct id: NCT03796910
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The purpose of the study is to evaluate the safety, tolerability, and pharmacokinetics (PK)
      following single and multiple ascending dose administration of SPR720 administered orally in
      healthy volunteers.
This is a single-center, phase I, randomized, double-blind, placebo-controlled, first-in-man
      study. Up to 120 healthy volunteers may be enrolled in this 2-part, multi-cohort study. In
      both Part 1 and Part 2, sequential cohorts will be exposed to increasing doses of SPR720.
      Each cohort will enrol 8 subjects, randomized (3:1) to receive SPR720 (6 subjects) or placebo
      (2 subjects). Each subject will be assigned to only one cohort.

      In Part 1 single ascending dose (SAD):

      A single oral dose of SPR720 (n=6) or placebo (n=2) will be administered to 8 subjects at an
      initial dose level of 100 mg. Additional cohorts of 8 subjects will be enrolled to
      investigate increasing doses of SPR720 ranging from 250 mg to 3000 mg. All subjects will
      receive SPR720 (or placebo) by oral administration in the fasted state. One Part 1 cohort
      (the Food Effect Cohort) will receive an additional single dose of SPR720 (or placebo) in the
      fed state.

      Part 2 multiple ascending dose (MAD):

      SPR720 (or placebo) will be administered to approximately 3 planned dose cohorts of 8
      subjects each. Subjects will receive SPR720 (or placebo) orally once daily for 7 (or 14)
      consecutive days starting with a planned initial dose of 500 mg. Additional cohorts of 8
      subjects will be enrolled to investigate repeated daily doses of SPR720 ranging from 1000 mg
      to 1500 mg.

      For both Part 1 and Part 2, a Safety Monitoring Group (SMG) will review cumulative safety and
      PK data from each cohort before proceeding to the next cohort/dose level. Doses to be
      evaluated in each subsequent cohort may be modified by the SMG based on review of safety and
      PK data from preceding cohorts. Part 2 will run concurrent with Part 1 and will be initiated
      following SMG review of safety and PK data for the corresponding Part 1 dose level cohort.

      Part 1 will be conducted in up to 64 subjects (8 planned dose cohorts of 8 subjects each).
      Part 2 will be conducted in up to 24 subjects (3 planned dose cohorts of 8 subjects each);
      additional cohorts of 8 subjects each (up to 16 additional subjects) may be enrolled in
      either Part if further investigation of SPR720 is required.
allocation: Randomized
intervention model: Sequential Assignment
intervention model description: Randomized, double-blind, placebo-controlled, single and multiple ascending dose (SAD and MAD) trial
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
masking description: Subjects will be randomized in a 3:1 ratio to receive SPR720 or placebo. The randomization code will produced by Simbec using the PROC PLAN procedure of SAS® version 9.3 or higher. The randomization code will include 2 dose-leaders (1 active:1 placebo) in each cohort who will be randomized prior to the remainder of the cohort. The allocation to SPR720 or placebo will be performed using a block randomization algorithm.
measure: Treatment emergent adverse events assessments after single and multiple dose administration at baseline and repeatedly until study completion [Safety and Tolerability]
time frame: Day 1 through last follow-up visit (5-7 days after last dose)
description: Incidence and severity of AEs
measure: Assessment of Pharmacokinetic Parameter (plasma): Cmax measurement
time frame: From Day 1 pre-dose to 48 hours post last dose
description: Maximum concentration of study drug in plasma
measure: Assessment of Pharmacokinetic Parameter (plasma): CmaxSS measurement
time frame: From Day 1 pre-dose to 48 hours post last dose
description: Maximum concentration of study drug in plasma at steady state
measure: Assessment of Pharmacokinetic Parameter (plasma): CminSS
time frame: From Day 1 pre-dose to 48 hours post last dose
description: Lowest concentration of study drug in a dosing interval in plasma
measure: Assessment of Pharmacokinetic Parameter (plasma): Ctrough
time frame: From Day 1 pre-dose to 48 hours post last dose
description: Concentration of study drug at the end of the dosing interval in plasma
measure: Assessment of Pharmacokinetic Parameter (plasma): CavSS
time frame: From Day 1 pre-dose to 48 hours post last dose
description: Average concentration of study drug in plasma during a dosing interval
measure: Assessment of Pharmacokinetic Parameter (plasma): Tmax
time frame: From Day 1 pre-dose to 48 hours post last dose
description: The time to maximum observed concentration of study drug in plasma
measure: Assessment of Pharmacokinetic Parameter (plasma): kel
time frame: From Day 1 pre-dose to 48 hours post last dose
description: Elimination rate constant of study drug in plasma
measure: Assessment of Pharmacokinetic Parameter (plasma): t1/2
time frame: From Day 1 pre-dose to 48 hours post last dose
description: Terminal elimination half-life of study drug in plasma
measure: Assessment of Pharmacokinetic Parameter (plasma): AUC0-24
time frame: From Day 1 pre-dose to 48 hours post last dose
description: Area under the concentration-time curve (AUC) of study drug in plasma from 0 to 24 hours post dose (dose escalation)
measure: Assessment of Pharmacokinetic Parameter (plasma): AUC0-tau
time frame: From Day 1 pre-dose to 48 hours post last dose
description: Area under the concentration-time curve (AUC) from 0 to tau, where tau is the dosing interval (multiple dose only) of study drug in plasma
measure: Assessment of Parameter (plasma): AUC0-t
time frame: From Day 1 pre-dose to 48 hours post last dose
description: Area under the concentration-time curve (AUC) of study drug in plasma from the time of dosing to the time of the last measurable concentration
measure: Assessment of Pharmacokinetic Parameter (plasma): AUC0-inf
time frame: From Day 1 pre-dose to 48 hours post last dose
description: AUC extrapolated to infinity of study drug in plasma
measure: Assessment of Parameter (plasma): AUC%extrapolated
time frame: From Day 1 pre-dose to 48 hours post last dose
description: Residual area of study drug in plasma
measure: Assessment of Pharmacokinetic Parameter (plasma): Degree of fluctuation
time frame: From Day 1 pre-dose to 48 hours post last dose
description: (Cmax-Cmin)/Cavss of study drug in plasma
measure: Assessment of Pharmacokinetic Parameter (plasma): Swing
time frame: From Day 1 pre-dose to 48 hours post last dose
description: (Cmaxss-Cminss)/Cminss of study drug in plasma
measure: Assessment of Pharmacokinetic Parameter (urine): SPR719
time frame: From Day 1 pre-dose to 24 hours post last dose
description: amount of SPR719 excreted in urine
arm group label: SPR720 for SAD
arm group type: Experimental
description: 6 out of 8 subjects per cohort will be randomized to receive SPR720
arm group label: Placebo for SAD
arm group type: Placebo Comparator
description: 2 out of 8 subjects per cohort will be randomized to receive placebo
arm group label: SPR720 for MAD
arm group type: Experimental
description: 6 out of 8 subjects per cohort will be randomized to receive SPR720
arm group label: Placebo for MAD
arm group type: Placebo Comparator
description: 2 out of 8 subjects per cohort will be randomized to receive placebo
intervention type: Drug
intervention name: SPR720 for SAD
description: Healthy subjects meeting eligibility criteria will be sequentially randomized to each dose cohort (up to 8 dose ascending cohorts) to receive either SPR720 or placebo. The study drug (SPR720 or placebo) will be administered as a single dose.
arm group label: SPR720 for SAD
other name: SPR720 Oral Capsule
intervention type: Drug
intervention name: Placebo for SAD
description: Healthy subjects meeting eligibility criteria will be sequentially randomized to each dose cohort (up to 8 dose ascending cohorts) to receive either SPR720 or placebo. The study drug (SPR720 or placebo) will be administered orally as a single dose.
arm group label: Placebo for SAD
other name: Placebo oral Capsule
intervention type: Drug
intervention name: SPR720 for MAD
description: Healthy subjects meeting eligibility criteria will be sequentially randomized to each dose cohort (up to 3 cohorts) to receive either SPR720 or placebo. The study drug (SPR720 or placebo) will be administered orally for a total of 7 (or 14) days of dosing.
arm group label: SPR720 for MAD
other name: SPR720 Oral Capsule
intervention type: Drug
intervention name: Placebo for MAD
description: Healthy subjects meeting eligibility criteria will be sequentially randomized to each dose cohort (up to 3 cohorts) to receive either SPR720 or placebo. The study drug (SPR720 or placebo) will be administered orally for a total of 7 (or 14) days of dosing
arm group label: Placebo for MAD
other name: Placebo Oral Capsule
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Annelize Koch, MBChB
role: Principal Investigator
affiliation: Simbec Research
facility: 
country: United Kingdom
responsible party type: Sponsor
sharing ipd: No