<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/NCT02220153</url>
  </required_header>
  <id_info>
    <org_study_id>UP0018</org_study_id>
    <secondary_id>2013-005469-38</secondary_id>
    <nct_id>NCT02220153</nct_id>
  </id_info>
  <brief_title>A First-In-Human Study With a Single Dose UCB7665 in Healthy Volunteers</brief_title>
  <official_title>A Subject-Blind, Investigator-blind, Randomized, Placebo-controlled, First-in-human Study Evaluating the Safety, Pharmacokinetics, and Pharmacodynamics of Single Ascending Intravenous and Subcutaneous Doses of UCB7665 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>
      This study is designed to evaluate the safety and tolerability of single ascending doses of&#xD;
      UCB7665 administered by intravenous or subcutaneous infusion in healthy subjects.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>July 2014</start_date>
  <completion_date type="Actual">September 2015</completion_date>
  <primary_completion_date type="Actual">September 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>Treatment</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 up to Day 85</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Maximum plasma concentration (Cmax)</measure>
    <time_frame>Predose (Day 1) up to Day 85</time_frame>
    <description>The value of the maximum plasma concentration will be directly obtained from the observed plasma concentration versus time curves. Pharmacokinetic samples will be taken predose, at the end of infusion, 4, 6, 8, 12, 24, 36, 48, 72, and 96 hours after start of infusion; and on Days 7, 10, 13, 16, 19, 22, 29, 43, 57, and 85.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area under the curve from 0 to infinity (AUC)</measure>
    <time_frame>Predose (Day 1) up to Day 85</time_frame>
    <description>AUC will be calculated using plasma concentrations taken at predose, at the end of infusion, 4, 6, 8, 12, 24, 36, 48, 72, and 96 hours after start of infusion; and on Days 7, 10, 13, 16, 19, 22, 29, 43, 57, and 85.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area under the curve from time 0 to time t, the time of last quantifiable concentration [AUC(0-t)]</measure>
    <time_frame>Predose (Day 1) up to Day 85</time_frame>
    <description>AUC(0-t) will be calculated using plasma concentrations taken at predose, at the end of infusion, 4, 6, 8, 12, 24, 36, 48, 72, and 96 hours after start of infusion; and on Days 7, 10, 13, 16, 19, 22, 29, 43, 57, and 85.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to reach Cmax (Tmax)</measure>
    <time_frame>Predose (Day 1) up to Day 85</time_frame>
    <description>Tmax will be directly obtained from the observed plasma concentration versus time curves, using plasma concentrations taken at predose, at the end of infusion, 4, 6, 8, 12, 24, 36, 48, 72, and 96 hours after start of infusion; and on Days 7, 10, 13, 16, 19, 22, 29, 43, 57, and 85.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total Immunoglobulin G (IgG ) concentrations</measure>
    <time_frame>Predose (Day 1) up to Day 85</time_frame>
    <description>Total Immunoglobulin G will be measured at predose, 24, 48, 72, and 96 hours postdose; and on Days 7, 10, 13, 16, 19, 22, 29, 43, 57, and 85.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Immunoglobulin G1 subclass concentrations</measure>
    <time_frame>Predose (Day 1) up to Day 85</time_frame>
    <description>Immunoglobulin subclass will be measured at predose, 24, 48, 72, and 96 hours postdose; and on Days 7, 10, 13, 16, 19, 22, 29, 43, 57, and 85.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Immunoglobulin G2 subclass concentrations</measure>
    <time_frame>Predose (Day 1) up to Day 85</time_frame>
    <description>Immunoglobulin subclass will be measured at predose, 24, 48, 72, and 96 hours postdose; and on Days 7, 10, 13, 16, 19, 22, 29, 43, 57, and 85.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Immunoglobulin G3 subclass concentrations</measure>
    <time_frame>Predose (Day 1) up to Day 85</time_frame>
    <description>Immunoglobulin subclass will be measured at predose, 24, 48, 72, and 96 hours postdose; and on Days 7, 10, 13, 16, 19, 22, 29, 43, 57, and 85.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Immunoglobulin G4 subclass concentrations</measure>
    <time_frame>Predose (Day 1) up to Day 85</time_frame>
    <description>Immunoglobulin subclass will be measured at predose, 24, 48, 72, and 96 hours postdose; and on Days 7, 10, 13, 16, 19, 22, 29, 43, 57, and 85.</description>
  </secondary_outcome>
  <number_of_arms>9</number_of_arms>
  <enrollment type="Actual">41</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>UCB7665 Intravenous 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Single dose calculated based on body weight for 60 minutes intravenous infusion.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>UCB7665 Intravenous 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Single dose calculated based on body weight for 60 minutes intravenous infusion.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>UCB7665 Intravenous 3</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Single dose calculated based on body weight for 60 minutes intravenous infusion.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>UCB7665 Intravenous 4</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Single dose calculated based on body weight for 60 minutes intravenous infusion.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>UCB7665 Intravenous 5</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Single dose calculated based on body weight for 60 minutes intravenous infusion.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>UCB7665 Subcutaneous 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Single dose calculated based on body weight for 60 minutes subcutaneous infusion.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>UCB7665 Subcutaneous 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Single dose calculated based on body weight for 60 minutes subcutaneous infusion.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intravenous Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Single dose placebo comparator for each active arm of intravenous infusion.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Subcutaneous Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Single dose placebo comparator for each active arm of subcutaneous infusion.</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>UCB7665 Intravenous 1</intervention_name>
    <description>Active substance: UCB7665&#xD;
Pharmaceutical form: solution&#xD;
Concentration: 140 mg/mL&#xD;
Route of Administration: intravenous infusion</description>
    <arm_group_label>UCB7665 Intravenous 1</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>UCB7665 Intravenous 2</intervention_name>
    <description>Active substance: UCB7665&#xD;
Pharmaceutical form: solution&#xD;
Concentration: 140 mg/mL&#xD;
Route of Administration: intravenous infusion</description>
    <arm_group_label>UCB7665 Intravenous 2</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>UCB7665 Intravenous 3</intervention_name>
    <description>Active substance: UCB7665&#xD;
Pharmaceutical form: solution&#xD;
Concentration: 140 mg/mL&#xD;
Route of Administration: intravenous infusion</description>
    <arm_group_label>UCB7665 Intravenous 3</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>UCB7665 Intravenous 4</intervention_name>
    <description>Active substance: UCB7665&#xD;
Pharmaceutical form: solution&#xD;
Concentration: 140 mg/mL&#xD;
Route of Administration: intravenous infusion</description>
    <arm_group_label>UCB7665 Intravenous 4</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>UCB7665 Intravenous 5</intervention_name>
    <description>Active substance: UCB7665&#xD;
Pharmaceutical form: solution&#xD;
Concentration: 140 mg/mL&#xD;
Route of Administration: intravenous infusion</description>
    <arm_group_label>UCB7665 Intravenous 5</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>UCB7665 Subcutaneous 1</intervention_name>
    <description>Active substance: UCB7665&#xD;
Pharmaceutical form: solution&#xD;
Concentration: 140 mg/mL&#xD;
Route of Administration: subcutaneous infusion</description>
    <arm_group_label>UCB7665 Subcutaneous 1</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>UCB7665 Subcutaneous 2</intervention_name>
    <description>Active substance: UCB7665&#xD;
Pharmaceutical form: solution&#xD;
Concentration: 140 mg/mL&#xD;
Route of Administration: subcutaneous infusion</description>
    <arm_group_label>UCB7665 Subcutaneous 2</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Intravenous Placebo</intervention_name>
    <description>Active substance: Placebo&#xD;
Pharmaceutical form: solution&#xD;
Concentration: 0.9 % saline&#xD;
Route of Administration: intravenous infusion</description>
    <arm_group_label>Intravenous Placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Subcutaneous Placebo</intervention_name>
    <description>Active substance: Placebo&#xD;
Pharmaceutical form: solution&#xD;
Concentration: 0.9 % saline&#xD;
Route of Administration: subcutaneous infusion</description>
    <arm_group_label>Subcutaneous Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy male and female volunteers of non-childbearing potential who gave their&#xD;
             consent to the written informed consent form&#xD;
&#xD;
          -  Healthy volunteers in the age between 18 and 64 years old with normal weight as&#xD;
             determined by a body mass index (BMI) between 18 and 30 kg/m^2, with a body weight of&#xD;
             at least 50 kg for male subjects or 45 kg for female subjects&#xD;
&#xD;
          -  Subjects has blood pressure (BP) and pulse within normal range in a supine position&#xD;
             after 5 minutes rest&#xD;
&#xD;
          -  Subject has clinical laboratory test results within the reference ranges of the&#xD;
             testing laboratory or test results that are outside the specified ranges and that are&#xD;
             deemed as clinically non-significant&#xD;
&#xD;
          -  Subject's electrocardiogram (ECG) is considered &quot;normal&quot; or &quot;abnormal&quot; but clinically&#xD;
             non-significant&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subject has had significant blood loss, or has donated blood in excess of 400 mL of&#xD;
             blood or blood products within 90 days before Day -2, or plans to donate blood during&#xD;
             the clinical study&#xD;
&#xD;
          -  Subject has a total Immuneglobulin G &lt;7 g/L or &gt;16 g/L at the Screening Visit&#xD;
&#xD;
          -  Subject has absolute neutrophil count &lt;1.5x10^9/L and/or lymphocyte count &lt;1.0x10^9/L&#xD;
&#xD;
          -  Subject has known viral hepatitis, has a positive test for Hepatitis B surface antigen&#xD;
             or is Hepatitis C virus antibody positive&#xD;
&#xD;
          -  Subject tests positive to Human Immunodeficiency Virus (HIV) 1/2 antibodies&#xD;
&#xD;
          -  Subject has a past medical history or family history of primary immunodeficiency&#xD;
&#xD;
          -  Subject is splenectomized&#xD;
&#xD;
          -  Subject has a positive TIGRA (T cell interferon γ release assay) at the Screening&#xD;
             Visit. If TIGRA is not available, purified protein derivative (PPD) skin test can be&#xD;
             substituted and/or chest x-ray performed within 6 months before the Screening Visit&#xD;
             showing no evidence of latent/active Tuberculosis (TB)&#xD;
&#xD;
          -  Subject has past (in the last 12 months ) or present substance abuse/dependence or&#xD;
             concurrent medical conditions that in the opinion of the investigator could confound&#xD;
             clinical study interpretation or affect the subject's ability to fully participate in&#xD;
             the clinical study&#xD;
&#xD;
          -  Subject has a known hypersensitivity to any components of the Investigational&#xD;
             Medicinal Product (IMP)&#xD;
&#xD;
          -  Subject has an active infection or has had a serious infection (resulting in&#xD;
             hospitalization or requiring parenteral antibiotic treatment) within 6 weeks before&#xD;
             the first dose of IMP&#xD;
&#xD;
          -  Subject has 12-lead electrocardiogram (ECG) with changes considered to be clinically&#xD;
             significant upon medical review&#xD;
&#xD;
          -  Subject has renal impairment&#xD;
&#xD;
          -  Subject has hepatic impairment&#xD;
&#xD;
          -  Subject has corrected serum calcium of &gt;11.5 mg/dL (&gt;2.9 mmol/L) or &lt;8.0 mg/dL (&lt;2.0&#xD;
             mmol/L) at the Screening Visit&#xD;
&#xD;
          -  Subject has active neoplastic disease or history of neoplastic disease within 5 years&#xD;
             of entry in the clinical study&#xD;
&#xD;
          -  Subject has any other acute or chronic illness which, in the opinion of the&#xD;
             investigator or study physician, could pose a threat or harm to the subjects&#xD;
&#xD;
          -  Subject has received a vaccination within 6 weeks before the Screening Visit or&#xD;
             intends to have a vaccination before Day 43 of the Safety Follow-up Period&#xD;
&#xD;
          -  Subject has received any IMP or experimental procedure within 90 days before the first&#xD;
             dose of IMP&#xD;
&#xD;
          -  Subject requires a treatment other than Paracetamol during the clinical study&#xD;
&#xD;
          -  Subject is a vulnerable subject (e.g. subject kept in detention) (Declaration of&#xD;
             Helsinki, 1996)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>64 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>UCB Pharma</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>001</name>
      <address>
        <city>Harrow</city>
        <state>Middlesex</state>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>October 2015</verification_date>
  <study_first_submitted>August 18, 2014</study_first_submitted>
  <study_first_submitted_qc>August 18, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 19, 2014</study_first_posted>
  <last_update_submitted>October 2, 2015</last_update_submitted>
  <last_update_submitted_qc>October 2, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 5, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Monoclonal antibody</keyword>
  <keyword>subjects</keyword>
  <keyword>First in human</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Rozanolixizumab</mesh_term>
  </intervention_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/NCT02220153
org study id: UP0018
secondary id: 2013-005469-38
nct id: NCT02220153
lead sponsor: 
collaborator: 
has dmc: No
This study is designed to evaluate the safety and tolerability of single ascending doses of
      UCB7665 administered by intravenous or subcutaneous infusion in healthy subjects.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Incidence of adverse events during the study
time frame: Day -1 up to Day 85
measure: Maximum plasma concentration (Cmax)
time frame: Predose (Day 1) up to Day 85
description: The value of the maximum plasma concentration will be directly obtained from the observed plasma concentration versus time curves. Pharmacokinetic samples will be taken predose, at the end of infusion, 4, 6, 8, 12, 24, 36, 48, 72, and 96 hours after start of infusion; and on Days 7, 10, 13, 16, 19, 22, 29, 43, 57, and 85.
measure: Area under the curve from 0 to infinity (AUC)
time frame: Predose (Day 1) up to Day 85
description: AUC will be calculated using plasma concentrations taken at predose, at the end of infusion, 4, 6, 8, 12, 24, 36, 48, 72, and 96 hours after start of infusion; and on Days 7, 10, 13, 16, 19, 22, 29, 43, 57, and 85.
measure: Area under the curve from time 0 to time t, the time of last quantifiable concentration [AUC(0-t)]
time frame: Predose (Day 1) up to Day 85
description: AUC(0-t) will be calculated using plasma concentrations taken at predose, at the end of infusion, 4, 6, 8, 12, 24, 36, 48, 72, and 96 hours after start of infusion; and on Days 7, 10, 13, 16, 19, 22, 29, 43, 57, and 85.
measure: Time to reach Cmax (Tmax)
time frame: Predose (Day 1) up to Day 85
description: Tmax will be directly obtained from the observed plasma concentration versus time curves, using plasma concentrations taken at predose, at the end of infusion, 4, 6, 8, 12, 24, 36, 48, 72, and 96 hours after start of infusion; and on Days 7, 10, 13, 16, 19, 22, 29, 43, 57, and 85.
measure: Total Immunoglobulin G (IgG ) concentrations
time frame: Predose (Day 1) up to Day 85
description: Total Immunoglobulin G will be measured at predose, 24, 48, 72, and 96 hours postdose; and on Days 7, 10, 13, 16, 19, 22, 29, 43, 57, and 85.
measure: Immunoglobulin G1 subclass concentrations
time frame: Predose (Day 1) up to Day 85
description: Immunoglobulin subclass will be measured at predose, 24, 48, 72, and 96 hours postdose; and on Days 7, 10, 13, 16, 19, 22, 29, 43, 57, and 85.
measure: Immunoglobulin G2 subclass concentrations
time frame: Predose (Day 1) up to Day 85
description: Immunoglobulin subclass will be measured at predose, 24, 48, 72, and 96 hours postdose; and on Days 7, 10, 13, 16, 19, 22, 29, 43, 57, and 85.
measure: Immunoglobulin G3 subclass concentrations
time frame: Predose (Day 1) up to Day 85
description: Immunoglobulin subclass will be measured at predose, 24, 48, 72, and 96 hours postdose; and on Days 7, 10, 13, 16, 19, 22, 29, 43, 57, and 85.
measure: Immunoglobulin G4 subclass concentrations
time frame: Predose (Day 1) up to Day 85
description: Immunoglobulin subclass will be measured at predose, 24, 48, 72, and 96 hours postdose; and on Days 7, 10, 13, 16, 19, 22, 29, 43, 57, and 85.
arm group label: UCB7665 Intravenous 1
arm group type: Experimental
description: Single dose calculated based on body weight for 60 minutes intravenous infusion.
arm group label: UCB7665 Intravenous 2
arm group type: Experimental
description: Single dose calculated based on body weight for 60 minutes intravenous infusion.
arm group label: UCB7665 Intravenous 3
arm group type: Experimental
description: Single dose calculated based on body weight for 60 minutes intravenous infusion.
arm group label: UCB7665 Intravenous 4
arm group type: Experimental
description: Single dose calculated based on body weight for 60 minutes intravenous infusion.
arm group label: UCB7665 Intravenous 5
arm group type: Experimental
description: Single dose calculated based on body weight for 60 minutes intravenous infusion.
arm group label: UCB7665 Subcutaneous 1
arm group type: Experimental
description: Single dose calculated based on body weight for 60 minutes subcutaneous infusion.
arm group label: UCB7665 Subcutaneous 2
arm group type: Experimental
description: Single dose calculated based on body weight for 60 minutes subcutaneous infusion.
arm group label: Intravenous Placebo
arm group type: Placebo Comparator
description: Single dose placebo comparator for each active arm of intravenous infusion.
arm group label: Subcutaneous Placebo
arm group type: Placebo Comparator
description: Single dose placebo comparator for each active arm of subcutaneous infusion.
intervention type: Biological
intervention name: UCB7665 Intravenous 1
description: Active substance: UCB7665
Pharmaceutical form: solution
Concentration: 140 mg/mL
Route of Administration: intravenous infusion
arm group label: UCB7665 Intravenous 1
intervention type: Biological
intervention name: UCB7665 Intravenous 2
description: Active substance: UCB7665
Pharmaceutical form: solution
Concentration: 140 mg/mL
Route of Administration: intravenous infusion
arm group label: UCB7665 Intravenous 2
intervention type: Biological
intervention name: UCB7665 Intravenous 3
description: Active substance: UCB7665
Pharmaceutical form: solution
Concentration: 140 mg/mL
Route of Administration: intravenous infusion
arm group label: UCB7665 Intravenous 3
intervention type: Biological
intervention name: UCB7665 Intravenous 4
description: Active substance: UCB7665
Pharmaceutical form: solution
Concentration: 140 mg/mL
Route of Administration: intravenous infusion
arm group label: UCB7665 Intravenous 4
intervention type: Biological
intervention name: UCB7665 Intravenous 5
description: Active substance: UCB7665
Pharmaceutical form: solution
Concentration: 140 mg/mL
Route of Administration: intravenous infusion
arm group label: UCB7665 Intravenous 5
intervention type: Biological
intervention name: UCB7665 Subcutaneous 1
description: Active substance: UCB7665
Pharmaceutical form: solution
Concentration: 140 mg/mL
Route of Administration: subcutaneous infusion
arm group label: UCB7665 Subcutaneous 1
intervention type: Biological
intervention name: UCB7665 Subcutaneous 2
description: Active substance: UCB7665
Pharmaceutical form: solution
Concentration: 140 mg/mL
Route of Administration: subcutaneous infusion
arm group label: UCB7665 Subcutaneous 2
intervention type: Biological
intervention name: Intravenous Placebo
description: Active substance: Placebo
Pharmaceutical form: solution
Concentration: 0.9 % saline
Route of Administration: intravenous infusion
arm group label: Intravenous Placebo
intervention type: Biological
intervention name: Subcutaneous Placebo
description: Active substance: Placebo
Pharmaceutical form: solution
Concentration: 0.9 % saline
Route of Administration: subcutaneous infusion
arm group label: Subcutaneous Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 64 Years
healthy volunteers: Accepts Healthy Volunteers
last name: UCB Clinical Trial Call Center
role: Study Director
affiliation: UCB Pharma
facility: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Rozanolixizumab