Clinical trial NCT03464227: A Study to Test the Safety, Pharmacokinetics, and Pharmacodynamics of Single Ascending Intravenous Doses of UCB0107 in Healthy Male Subjects
Official title: A Subject-Blind, Investigator-Blind, Randomized, Placebo-Controlled, First-in-Human Study to Evaluate Safety and Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Ascending Intravenous Doses of UCB0107 in Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Male Volunteers
Keywords: Phase 1
UCB0107
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2018-03-13
Enrollment: 52
Sex: MALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of the study is to evaluate the safety and tolerability of single ascending doses of UCB0107 administered by intravenous (iv) infusion in healthy male subjects.


Eligibility criteria: Inclusion Criteria:

* Subject is male, \>= 18 and \<= 75 years of age
* Subject has a body mass index (BMI) \>= 18.0 and \< 30.0 kg/m\^2, with a body weight of at least 50 kg and maximum 100 kg
* Subject is in good physical and mental health
* Subject has clinical laboratory test results within the reference ranges of the laboratory
* Subject's electrocardiogram (ECG) is considered "normal," or "abnormal" but clinically non-significant (as interpreted by the investigator)
* Male subject confirms that, during the study period and for a period of 6 months or 5 half-lives of the investigational medicinal product (IMP) (whichever is longer), when having sexual intercourse with a woman of childbearing potential, a method of efficient contraception will be used, including a barrier AND an additional highly effective contraceptive method by the female partner

Exclusion Criteria:

* Subject is an employee or direct relative of an employee of the contract research organization (CRO) or UCB
* Subject has previously been assigned to treatment in this study or in another study of the medication under investigation in this study
* Subject is considered to be a vulnerable participant
* Subject has had major surgery (including joint surgery) within 6 months prior to Screening, or has planned surgery within 6 months after study treatment
* Subject has an active infection (eg, sepsis, pneumonia, abscess) or has had a serious infection (resulting in hospitalization or requiring parenteral antibiotic treatment) within 4 weeks before the first dose of IMP

Primary outcomes:
measure: The incidence of Adverse Events (AEs) during the study
timeFrame: During the study from Visit 1 up to the Safety Follow-Up Visit (Week 20)
Secondary outcomes:
measure: The Maximum concentration (Cmax) for UCB0107 in serum and cerebrospinal fluid
timeFrame: Pharmacokinetic samples and samples from cerebrospinal fluid will be taken at pre-defined time points throughout study completion (up to Week 20)
measure: The area under the concentration-time curve from time 0 to infinity (AUC) in serum and cerebrospinal fluid
timeFrame: Pharmacokinetic samples and samples from cerebrospinal fluid will be taken at pre-defined time points throughout study completion (up to Week 20)
measure: The area under the concentration-time curve from time 0 to time t, the time of the last quantifiable concentration (AUC(0-t)) in serum and cerebrospinal fluid
timeFrame: Pharmacokinetic samples and samples from cerebrospinal fluid will be taken at pre-defined time points throughout study completion (up to Week 20)
measure: The time to maximum concentration (tmax) for UCB0107 in serum and cerebrospinal fluid
timeFrame: Pharmacokinetic samples and samples from cerebrospinal fluid will be taken at pre-defined time points throughout study completion (up to Week 20)
measure: The terminal half-life (t½) of UCB0107 in serum
timeFrame: Pharmacokinetic samples will be taken at pre-defined time points throughout study completion (up to Week 20)
measure: The total Clearance (CL) for UCB0107 in serum
timeFrame: Pharmacokinetic samples will be taken at pre-defined time points throughout study completion (up to Week 20)
measure: The volume of distribution (Vz) for UCB0107 in serum
timeFrame: Pharmacokinetic samples will be taken at pre-defined time points throughout study completion (up to Week 20)
measure: CSF/serum ratio of antibody concentrations
timeFrame: Pharmacokinetic samples and samples from cerebrospinal fluid will be taken at pre-defined time points throughout study completion (up to Week 20)
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Up0047 001
Study officials:
affiliation: 001 844 599 2273 (UCB)
name: UCB Cares
role: STUDY_DIRECTOR
References: