<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/NCT02207595</url>
  </required_header>
  <id_info>
    <org_study_id>UP0021</org_study_id>
    <secondary_id>2014-002361-30</secondary_id>
    <nct_id>NCT02207595</nct_id>
  </id_info>
  <brief_title>Study to Assess the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Profiles of UCB5857 in Healthy Subjects</brief_title>
  <official_title>A Randomized, Investigator- and Subject-blind, Placebo-controlled, Combined Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Profiles of UCB5857 in Healthy Subjects</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>UCB Celltech</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Parexel</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>UCB Pharma</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary objective of this study is to investigate the safety and tolerability of UCB5857.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>August 2014</start_date>
  <completion_date type="Actual">February 2015</completion_date>
  <primary_completion_date type="Actual">February 2015</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>Basic Science</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence of Adverse Events during the study</measure>
    <time_frame>Day -1 to multiple dose Day 17</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Area under the plasma concentration-time curve from time 0 to the last quantifiable concentration (AUC(0-t))</measure>
    <time_frame>Pharmacokinetic samples will be taken predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 24, 48 and 72 hours postdose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area under the plasma concentration-time curve from time 0 to 24 hours (AUC(0-24))</measure>
    <time_frame>Pharmacokinetic samples will be taken predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 24, 48 and 72 hours postdose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area under the plasma concentration-time curve from time 0 to infinity (AUC)</measure>
    <time_frame>Pharmacokinetic samples will be taken predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 24, 48 and 72 hours postdose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The maximum observed plasma concentration of UCB5857 after single dosing, obtained directly from the observed plasma concentration-time curves (Cmax)</measure>
    <time_frame>Pharmacokinetic samples will be taken predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 24, 48 and 72 hours postdose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The time of occurrence of Cmax, obtained directly from the observed plasma concentration-time curves (tmax)</measure>
    <time_frame>Pharmacokinetic samples will be taken predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 24, 48 and 72 hours postdose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The apparent terminal half-life (t1/2)</measure>
    <time_frame>Pharmacokinetic samples will be taken predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 24, 48 and 72 hours postdose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The terminal elimination rate constant in plasma (λz)</measure>
    <time_frame>Pharmacokinetic samples will be taken predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 24, 48 and 72 hours postdose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The apparent volume of distribution after single dosing (Vz/F)</measure>
    <time_frame>Pharmacokinetic samples will be taken predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 24, 48 and 72 hours postdose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The apparent total body clearance after single dosing (CL/F)</measure>
    <time_frame>Pharmacokinetic samples will be taken predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 24, 48 and 72 hours postdose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean residence time (MRT)</measure>
    <time_frame>Pharmacokinetic samples will be taken predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 24, 48 and 72 hours postdose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area under the plasma concentration-time curve from time 0 to the last quantifiable concentration (AUC(0-t))</measure>
    <time_frame>Pharmacokinetic samples will be taken predose on MD-Days 1 to 13, predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 10 hours postdose on MD-Day 14, 24 hours postdose (MD-Day 15), 48 hours postdose (MD-Day 16) and 72 hours postdose (MD-Day 17)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area under the plasma concentration-time curve from time 0 to 24 hours (AUC(0-24))</measure>
    <time_frame>Pharmacokinetic samples will be taken predose on MD-Days 1 to 13, predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 10 hours postdose on MD-Day 14, 24 hours postdose (MD-Day 15), 48 hours postdose (MD-Day 16) and 72 hours postdose (MD-Day 17)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The time of occurrence of Cmax, obtained directly from the observed plasma concentration-time curves (tmax)</measure>
    <time_frame>Pharmacokinetic samples will be taken predose on MD-Days 1 to 13, predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 10 hours postdose on MD-Day 14, 24 hours postdose (MD-Day 15), 48 hours postdose (MD-Day 16) and 72 hours postdose (MD-Day 17)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The apparent terminal half-life (t1/2)</measure>
    <time_frame>Pharmacokinetic samples will be taken predose on MD-Days 1 to 13, predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 10 hours postdose on MD-Day 14, 24 hours postdose (MD-Day 15), 48 hours postdose (MD-Day 16) and 72 hours postdose (MD-Day 17)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The terminal elimination rate constant in plasma (λz)</measure>
    <time_frame>Pharmacokinetic samples will be taken predose on MD-Days 1 to 13, predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 10 hours postdose on MD-Day 14, 24 hours postdose (MD-Day 15), 48 hours postdose (MD-Day 16) and 72 hours postdose (MD-Day 17)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean residence time (MRT)</measure>
    <time_frame>Pharmacokinetic samples will be taken predose on MD-Days 1 to 13, predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 10 hours postdose on MD-Day 14, 24 hours postdose (MD-Day 15), 48 hours postdose (MD-Day 16) and 72 hours postdose (MD-Day 17)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The apparent volume of distribution at steady state (Vzss/F)</measure>
    <time_frame>Pharmacokinetic samples will be taken predose on MD-Days 1 to 13, predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 10 hours postdose on MD-Day 14, 24 hours postdose (MD-Day 15), 48 hours postdose (MD-Day 16) and 72 hours postdose (MD-Day 17)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The apparent total body clearance at steady state (CLss/F)</measure>
    <time_frame>Pharmacokinetic samples will be taken predose on MD-Days 1 to 13, predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 10 hours postdose on MD-Day 14, 24 hours postdose (MD-Day 15), 48 hours postdose (MD-Day 16) and 72 hours postdose (MD-Day 17)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The maximum observed plasma concentration of UCB5857 during steady state, obtained directly from the observed plasma concentration-time curves (Cmaxss)</measure>
    <time_frame>Pharmacokinetic samples will be taken predose on MD-Days 1 to 13, predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 10 hours postdose on MD-Day 14, 24 hours postdose (MD-Day 15), 48 hours postdose (MD-Day 16) and 72 hours postdose (MD-Day 17)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The minimum observed plasma concentration of UCB5857 during steady state immediately before the next dose would be administered, obtained directly from the observed plasma concentration-time curves (Ctrough)</measure>
    <time_frame>Pharmacokinetic samples will be taken predose on MD-Days 1 to 13, predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 10 hours postdose on MD-Day 14, 24 hours postdose (MD-Day 15), 48 hours postdose (MD-Day 16) and 72 hours postdose (MD-Day 17)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Accumulation factor based on AUC(0-24) (RAUC)</measure>
    <time_frame>Pharmacokinetic samples will be taken predose on MD-Days 1 to 13, predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 10 hours postdose on MD-Day 14, 24 hours postdose (MD-Day 15), 48 hours postdose (MD-Day 16) and 72 hours postdose (MD-Day 17)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Accumulation factor based on Cmax (R(Cmax))</measure>
    <time_frame>Pharmacokinetic samples will be taken predose on MD-Days 1 to 13, predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 10 hours postdose on MD-Day 14, 24 hours postdose (MD-Day 15), 48 hours postdose (MD-Day 16) and 72 hours postdose (MD-Day 17)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time independency factor (TI)</measure>
    <time_frame>Pharmacokinetic samples will be taken predose on MD-Days 1 to 13, predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 10 hours postdose on MD-Day 14, 24 hours postdose (MD-Day 15), 48 hours postdose (MD-Day 16) and 72 hours postdose (MD-Day 17)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Basophil degranulation</measure>
    <time_frame>Samples will be taken at Screening, SD-Day 1 (predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10 hours postdose) and 24, 48 hours postdose. Samples will also be taken on MD-Days 4, 8 , 13 at predose, 0.25, 0.5, 1, 2, 4, 6, 8 and 10 hours postdose</time_frame>
  </secondary_outcome>
  <number_of_arms>5</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Healthy Volunteers</condition>
  <arm_group>
    <arm_group_label>UCB5857 Cohort 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>UCB5857 and Placebo: Single dose followed by multiple doses over 14 days</description>
  </arm_group>
  <arm_group>
    <arm_group_label>UCB5857 Cohort 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>UCB5857 and Placebo: Single dose followed by multiple doses over 14 days</description>
  </arm_group>
  <arm_group>
    <arm_group_label>UCB5857 Cohort 3</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>UCB5857 and Placebo: Single dose followed by multiple doses over 14 days</description>
  </arm_group>
  <arm_group>
    <arm_group_label>UCB5857 Cohort 4</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>UCB5857 and Placebo: Single dose followed by multiple doses over 14 days</description>
  </arm_group>
  <arm_group>
    <arm_group_label>UCB5857 Cohort 5</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>UCB5857 and Placebo: Single dose followed by multiple doses over 14 days</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>UCB5857</intervention_name>
    <description>Active Substance: UCB5857&#xD;
Pharmaceutical Form: Capsule&#xD;
Concentrations: 5 mg, 10 mg, 20 mg, 30 mg, 50 mg, 100 mg&#xD;
Route of Administration: Oral Use</description>
    <arm_group_label>UCB5857 Cohort 1</arm_group_label>
    <arm_group_label>UCB5857 Cohort 2</arm_group_label>
    <arm_group_label>UCB5857 Cohort 3</arm_group_label>
    <arm_group_label>UCB5857 Cohort 4</arm_group_label>
    <arm_group_label>UCB5857 Cohort 5</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Active Substance: Placebo&#xD;
Pharmaceutical Form: Capsule&#xD;
Concentrations: 5 mg, 10 mg, 20 mg, 30 mg, 50 mg, 100 mg&#xD;
Route of Administration: Oral Use</description>
    <arm_group_label>UCB5857 Cohort 1</arm_group_label>
    <arm_group_label>UCB5857 Cohort 2</arm_group_label>
    <arm_group_label>UCB5857 Cohort 3</arm_group_label>
    <arm_group_label>UCB5857 Cohort 4</arm_group_label>
    <arm_group_label>UCB5857 Cohort 5</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        To be eligible to participate in this study, all of the following criteria must be met:&#xD;
&#xD;
          -  An Independent Ethics Committee (IEC)-approved written Informed Consent Form is signed&#xD;
             and dated by the subject&#xD;
&#xD;
          -  Subject is considered reliable and capable of adhering to the protocol (eg, able to&#xD;
             understand and complete diaries), visit schedule, or medication intake according to&#xD;
             the judgment of the Investigator&#xD;
&#xD;
          -  Subject is male or female, 18 to 55 years of age (inclusive)&#xD;
&#xD;
          -  Female subjects must have a negative pregnancy test in urine at the Screening Visit&#xD;
             and a negative serum pregnancy test on Day -1, and be of nonchildbearing potential,&#xD;
             defined as being:&#xD;
&#xD;
               1. Postmenopausal (for at least 2 years before the Screening Visit), verified by&#xD;
                  serum follicle-stimulating hormone (FSH) level &gt;40 mIU/mL at the Screening Visit,&#xD;
                  or&#xD;
&#xD;
               2. Permanently sterilized (eg, tubal occlusion, hysterectomy, bilateral&#xD;
                  salpingectomy), or&#xD;
&#xD;
               3. Congenitally sterile&#xD;
&#xD;
          -  Contraception methods for male subjects and their female partners:&#xD;
&#xD;
               1. Male subject with a partner of childbearing potential must be willing to use a&#xD;
                  condom when sexually active&#xD;
&#xD;
               2. The female partner of childbearing potential of a male subject must be willing to&#xD;
                  use at least 2 effective methods of contraception, including a barrier method&#xD;
                  (eg, male condom, female condom, or diaphragm with spermicide) during the study&#xD;
                  period.&#xD;
&#xD;
        Both sexes must use the above mentioned contraception methods (condoms for males) during&#xD;
        the study and for 20 weeks after the last administration of the Investigational Medicinal&#xD;
        Product (IMP) (anticipated 5 half-lives).&#xD;
&#xD;
          -  Subject is of normal weight as determined by a body mass index (BMI) of 18.0 to 30.0&#xD;
             kg/m^2 (inclusive), with a body weight of at least 50 kg&#xD;
&#xD;
          -  Subject has clinical laboratory test results within the reference ranges of the&#xD;
             testing laboratory&#xD;
&#xD;
          -  Subject has Blood Pressure (BP) and pulse within normal range in a supine position&#xD;
             after 5 minutes rest (systolic BP: 90 to 140 mmHg, diastolic BP: 50 to 90 mmHg, pulse:&#xD;
             40 to 90 beats per minute - all inclusive)&#xD;
&#xD;
          -  Subject's ECG is considered &quot;normal&quot; or &quot;abnormal but clinically nonsignificant&quot; (as&#xD;
             interpreted by the Investigator)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Subjects are not permitted to enroll in the study if any of the following criteria is met:&#xD;
&#xD;
          -  Subject has a known hypersensitivity to any components of the Investigational&#xD;
             Medicinal Product (IMP)&#xD;
&#xD;
          -  Subject is considered anti-high-affinity immunoglobulin E (IgE) receptor nonresponsive&#xD;
             if CD63 induction on basophils is &lt;10 %&#xD;
&#xD;
          -  Subject has cardiovascular or cerebrovascular disease, including hypertension, angina,&#xD;
             ischemic heart disease, transient ischemic attacks, stroke, and peripheral arterial&#xD;
             disease sufficient to cause symptoms and/or require therapy to maintain stable status&#xD;
&#xD;
          -  Subject has diabetes mellitus of any type requiring insulin&#xD;
&#xD;
          -  Subject has&#xD;
&#xD;
               1. an active infection (eg, sepsis, pneumonia, abscess)&#xD;
&#xD;
               2. history of latent, chronic, or recurrent infections (eg, tuberculosis [TB],&#xD;
                  recurrent sinusitis, genital herpes, urinary tract infections) or at risk of&#xD;
                  infection (surgery, trauma, infection requiring antibiotics, history of skin&#xD;
                  abscesses) within 3 months before IMP administration&#xD;
&#xD;
               3. experienced a significant episode of gastroenteritis (defined as loose stools&#xD;
                  associated with abdominal pain and/or fever) during the 7 days before IMP&#xD;
                  administration&#xD;
&#xD;
        When in doubt, the Investigator should confer with the Sponsor's Study Physician.&#xD;
&#xD;
          -  Subject has a history of positive TB test or evidence of possible TB or latent TB&#xD;
             infection at the Screening Visit (QuantiFERON® Gold Test)&#xD;
&#xD;
          -  Subject has received live attenuated vaccination within 3 months or any other type of&#xD;
             vaccine within 4 weeks before the Screening Visit or intends to have such a&#xD;
             vaccination during the course of the study&#xD;
&#xD;
          -  Subject who has any of the following hematology values at the Screening Visit:&#xD;
             Hemoglobin; for women &lt;11 g/dL; for men &lt;13 g/dL Absolute Neutrophil Count (ANC) &lt;1.5&#xD;
             x 109/L (&lt;1000/mm^3)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>UCB Clinical Trial Call Center</last_name>
    <role>Study Director</role>
    <affiliation>+1 877 822 9493 (UCB)</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>1</name>
      <address>
        <city>Harrow</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>March 2015</verification_date>
  <study_first_submitted>August 1, 2014</study_first_submitted>
  <study_first_submitted_qc>August 1, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 4, 2014</study_first_posted>
  <last_update_submitted>March 4, 2015</last_update_submitted>
  <last_update_submitted_qc>March 4, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">March 5, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT02207595
org study id: UP0021
secondary id: 2014-002361-30
nct id: NCT02207595
lead sponsor: 
collaborator: 
has dmc: No
The primary objective of this study is to investigate the safety and tolerability of UCB5857.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: Double (Participant, Investigator)
measure: Incidence of Adverse Events during the study
time frame: Day -1 to multiple dose Day 17
measure: Area under the plasma concentration-time curve from time 0 to the last quantifiable concentration (AUC(0-t))
time frame: Pharmacokinetic samples will be taken predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 24, 48 and 72 hours postdose
measure: Area under the plasma concentration-time curve from time 0 to 24 hours (AUC(0-24))
time frame: Pharmacokinetic samples will be taken predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 24, 48 and 72 hours postdose
measure: Area under the plasma concentration-time curve from time 0 to infinity (AUC)
time frame: Pharmacokinetic samples will be taken predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 24, 48 and 72 hours postdose
measure: The maximum observed plasma concentration of UCB5857 after single dosing, obtained directly from the observed plasma concentration-time curves (Cmax)
time frame: Pharmacokinetic samples will be taken predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 24, 48 and 72 hours postdose
measure: The time of occurrence of Cmax, obtained directly from the observed plasma concentration-time curves (tmax)
time frame: Pharmacokinetic samples will be taken predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 24, 48 and 72 hours postdose
measure: The apparent terminal half-life (t1/2)
time frame: Pharmacokinetic samples will be taken predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 24, 48 and 72 hours postdose
measure: The terminal elimination rate constant in plasma (λz)
time frame: Pharmacokinetic samples will be taken predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 24, 48 and 72 hours postdose
measure: The apparent volume of distribution after single dosing (Vz/F)
time frame: Pharmacokinetic samples will be taken predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 24, 48 and 72 hours postdose
measure: The apparent total body clearance after single dosing (CL/F)
time frame: Pharmacokinetic samples will be taken predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 24, 48 and 72 hours postdose
measure: Mean residence time (MRT)
time frame: Pharmacokinetic samples will be taken predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 24, 48 and 72 hours postdose
measure: Area under the plasma concentration-time curve from time 0 to the last quantifiable concentration (AUC(0-t))
time frame: Pharmacokinetic samples will be taken predose on MD-Days 1 to 13, predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 10 hours postdose on MD-Day 14, 24 hours postdose (MD-Day 15), 48 hours postdose (MD-Day 16) and 72 hours postdose (MD-Day 17)
measure: Area under the plasma concentration-time curve from time 0 to 24 hours (AUC(0-24))
time frame: Pharmacokinetic samples will be taken predose on MD-Days 1 to 13, predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 10 hours postdose on MD-Day 14, 24 hours postdose (MD-Day 15), 48 hours postdose (MD-Day 16) and 72 hours postdose (MD-Day 17)
measure: The time of occurrence of Cmax, obtained directly from the observed plasma concentration-time curves (tmax)
time frame: Pharmacokinetic samples will be taken predose on MD-Days 1 to 13, predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 10 hours postdose on MD-Day 14, 24 hours postdose (MD-Day 15), 48 hours postdose (MD-Day 16) and 72 hours postdose (MD-Day 17)
measure: The apparent terminal half-life (t1/2)
time frame: Pharmacokinetic samples will be taken predose on MD-Days 1 to 13, predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 10 hours postdose on MD-Day 14, 24 hours postdose (MD-Day 15), 48 hours postdose (MD-Day 16) and 72 hours postdose (MD-Day 17)
measure: The terminal elimination rate constant in plasma (λz)
time frame: Pharmacokinetic samples will be taken predose on MD-Days 1 to 13, predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 10 hours postdose on MD-Day 14, 24 hours postdose (MD-Day 15), 48 hours postdose (MD-Day 16) and 72 hours postdose (MD-Day 17)
measure: Mean residence time (MRT)
time frame: Pharmacokinetic samples will be taken predose on MD-Days 1 to 13, predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 10 hours postdose on MD-Day 14, 24 hours postdose (MD-Day 15), 48 hours postdose (MD-Day 16) and 72 hours postdose (MD-Day 17)
measure: The apparent volume of distribution at steady state (Vzss/F)
time frame: Pharmacokinetic samples will be taken predose on MD-Days 1 to 13, predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 10 hours postdose on MD-Day 14, 24 hours postdose (MD-Day 15), 48 hours postdose (MD-Day 16) and 72 hours postdose (MD-Day 17)
measure: The apparent total body clearance at steady state (CLss/F)
time frame: Pharmacokinetic samples will be taken predose on MD-Days 1 to 13, predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 10 hours postdose on MD-Day 14, 24 hours postdose (MD-Day 15), 48 hours postdose (MD-Day 16) and 72 hours postdose (MD-Day 17)
measure: The maximum observed plasma concentration of UCB5857 during steady state, obtained directly from the observed plasma concentration-time curves (Cmaxss)
time frame: Pharmacokinetic samples will be taken predose on MD-Days 1 to 13, predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 10 hours postdose on MD-Day 14, 24 hours postdose (MD-Day 15), 48 hours postdose (MD-Day 16) and 72 hours postdose (MD-Day 17)
measure: The minimum observed plasma concentration of UCB5857 during steady state immediately before the next dose would be administered, obtained directly from the observed plasma concentration-time curves (Ctrough)
time frame: Pharmacokinetic samples will be taken predose on MD-Days 1 to 13, predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 10 hours postdose on MD-Day 14, 24 hours postdose (MD-Day 15), 48 hours postdose (MD-Day 16) and 72 hours postdose (MD-Day 17)
measure: Accumulation factor based on AUC(0-24) (RAUC)
time frame: Pharmacokinetic samples will be taken predose on MD-Days 1 to 13, predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 10 hours postdose on MD-Day 14, 24 hours postdose (MD-Day 15), 48 hours postdose (MD-Day 16) and 72 hours postdose (MD-Day 17)
measure: Accumulation factor based on Cmax (R(Cmax))
time frame: Pharmacokinetic samples will be taken predose on MD-Days 1 to 13, predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 10 hours postdose on MD-Day 14, 24 hours postdose (MD-Day 15), 48 hours postdose (MD-Day 16) and 72 hours postdose (MD-Day 17)
measure: Time independency factor (TI)
time frame: Pharmacokinetic samples will be taken predose on MD-Days 1 to 13, predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 10 hours postdose on MD-Day 14, 24 hours postdose (MD-Day 15), 48 hours postdose (MD-Day 16) and 72 hours postdose (MD-Day 17)
measure: Basophil degranulation
time frame: Samples will be taken at Screening, SD-Day 1 (predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10 hours postdose) and 24, 48 hours postdose. Samples will also be taken on MD-Days 4, 8 , 13 at predose, 0.25, 0.5, 1, 2, 4, 6, 8 and 10 hours postdose
arm group label: UCB5857 Cohort 1
arm group type: Experimental
description: UCB5857 and Placebo: Single dose followed by multiple doses over 14 days
arm group label: UCB5857 Cohort 2
arm group type: Experimental
description: UCB5857 and Placebo: Single dose followed by multiple doses over 14 days
arm group label: UCB5857 Cohort 3
arm group type: Experimental
description: UCB5857 and Placebo: Single dose followed by multiple doses over 14 days
arm group label: UCB5857 Cohort 4
arm group type: Experimental
description: UCB5857 and Placebo: Single dose followed by multiple doses over 14 days
arm group label: UCB5857 Cohort 5
arm group type: Experimental
description: UCB5857 and Placebo: Single dose followed by multiple doses over 14 days
intervention type: Drug
intervention name: UCB5857
description: Active Substance: UCB5857
Pharmaceutical Form: Capsule
Concentrations: 5 mg, 10 mg, 20 mg, 30 mg, 50 mg, 100 mg
Route of Administration: Oral Use
arm group label: UCB5857 Cohort 1
arm group label: UCB5857 Cohort 2
arm group label: UCB5857 Cohort 3
arm group label: UCB5857 Cohort 4
arm group label: UCB5857 Cohort 5
intervention type: Other
intervention name: Placebo
description: Active Substance: Placebo
Pharmaceutical Form: Capsule
Concentrations: 5 mg, 10 mg, 20 mg, 30 mg, 50 mg, 100 mg
Route of Administration: Oral Use
arm group label: UCB5857 Cohort 1
arm group label: UCB5857 Cohort 2
arm group label: UCB5857 Cohort 3
arm group label: UCB5857 Cohort 4
arm group label: UCB5857 Cohort 5
criteria: 
gender: All
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
last name: UCB Clinical Trial Call Center
role: Study Director
affiliation: +1 877 822 9493 (UCB)
facility: 
country: United Kingdom
responsible party type: Sponsor