A First-In-Human Study With a Single Dose UCB4019 in Healthy Volunteers
NCT ID: NCT02873767
Last Updated: 2017-02-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
32 participants
INTERVENTIONAL
2016-08-31
2017-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
TRIPLE
Study Groups
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Placebo
Single dose placebo comparator for each active arm
PL1
* Active substance: Placebo
* Concentration: 0.9 % saline
* Route of Administration: subcutaneously
UCB4019 Dose 1
Dose 1 calculated based on body weight
PR1
* Active substance: UCB4019
* Route of Administration: subcutaneously
UCB4019 Dose 2
Dose 2 calculated based on body weight
PR1
* Active substance: UCB4019
* Route of Administration: subcutaneously
UCB4019 Dose 3
Dose 3 calculated based on body weight
PR1
* Active substance: UCB4019
* Route of Administration: subcutaneously
UCB4019 Dose 4
Dose 4 calculated based on body weight
PR1
* Active substance: UCB4019
* Route of Administration: subcutaneously
Interventions
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PR1
* Active substance: UCB4019
* Route of Administration: subcutaneously
PL1
* Active substance: Placebo
* Concentration: 0.9 % saline
* Route of Administration: subcutaneously
Eligibility Criteria
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Inclusion Criteria
* At least 18 and less than 65 years of age
* Female subjects of childbearing potential must agree to use a highly effective method of birth control, during the study and for a period of 3 months after their last dose of study drug
Exclusion Criteria
* Absolute neutrophil count \<1.5x10\^9/L and/or lymphocyte count \<1.0x10\^9/L
* Known viral hepatitis, has a positive test for Hepatitis B surface antigen or is Hepatitis C virus antibody positive
* Positive test to Human Immunodeficiency Virus (HIV) 1/2 antibodies
* Past medical history or family history of primary immunodeficiency
* Evidence of latent/active Tuberculosis (TB)
* Active infection or a serious infection within 6 weeks before the first dose of IMP
* Renal impairment
* Hepatic impairment
* Vaccination within 6 weeks before the Screening Visit or intent to have a vaccination before Day 43 of the Safety Follow-up Period
* Subject is splenectomized
* received any IMP or experimental procedure within 90 days before the first dose of IMP
* received UCB7665 in a clinical study
18 Years
64 Years
ALL
Yes
Sponsors
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UCB Biopharma S.P.R.L.
INDUSTRY
Responsible Party
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Principal Investigators
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UCB Cares
Role: STUDY_DIRECTOR
UCB (+1 887 822 9493)
Locations
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Up0028 001
London, , United Kingdom
Countries
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Other Identifiers
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2016-000772-26
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
UP0028
Identifier Type: -
Identifier Source: org_study_id
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