Clinical trial NCT02873767: A First-In-Human Study With a Single Dose UCB4019 in Healthy Volunteers
Official title: A Subject-Blind, Investigator-Blind, Randomized, Placebo-Controlled, First-In-Human Study Evaluating the Safety, Pharmacokinetics, and Pharmacodynamics of Single Ascending Subcutaneous Doses of UCB4019 in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Keywords: First in human
Healthy volunteers
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2016-08-19
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: This study is designed to evaluate the safety and tolerability of single ascending doses of UCB4019 administered by subcutaneous injection in healthy subjects.


Eligibility criteria: Inclusion Criteria:

* Good physical and mental health
* 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:

* Total Immunoglobulin G \<7 g/L or \>16 g/L at the Screening Visit
* 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

Primary outcomes:
measure: Incidence of treatment emergent adverse events during the study
timeFrame: Day 1 up to Day 57
Secondary outcomes:
measure: Maximum plasma concentration (Cmax)
timeFrame: Pharmacokinetic samples will be taken predose, immediately after the end of infusion, 4, 6, 8, 12, 24, 36, 48, 72, and 96 hours postdose and Days 7, 10, 13, 16, 19
measure: Area under the curve from 0 to time t, the time of last quantifiable concentration [(AUC0-t)]
timeFrame: Pharmacokinetic samples will be taken predose, immediately after the end of infusion, 4, 6, 8, 12, 24, 36, 48, 72, and 96 hours postdose and Days 7, 10, 13, 16, 19
measure: Time to reach Cmax (Tmax)
timeFrame: Pharmacokinetic samples will be taken predose, immediately after the end of infusion, 4, 6, 8, 12, 24, 36, 48, 72, and 96 hours postdose and Days 7, 10, 13, 16, 19
measure: Change from Baseline in total Immunoglobulin G (IgG) concentration at day 7
timeFrame: Predose (Day 1), Day 7
measure: Change from Baseline in total Immunoglobulin G (IgG) concentration at day 10
timeFrame: Predose (Day 1), Day 10
measure: Change from Baseline in total Immunoglobulin G (IgG) concentration at day 13
timeFrame: Predose (Day 1), Day 13
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Up0028 001
Study officials:
affiliation: UCB (+1 887 822 9493)
name: UCB Cares
role: STUDY_DIRECTOR
References: