Status:
COMPLETED
A Study to Test the Safety, Pharmacokinetics, and Pharmacodynamics of Single Ascending Intravenous Doses of UCB0107 in Healthy Male Subjects
Lead Sponsor:
UCB Biopharma S.P.R.L.
Conditions:
Healthy Male Volunteers
Eligibility:
MALE
18-75 years
Phase:
PHASE1
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
- 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
- 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
Key Trial Info
Start Date :
February 16 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2018
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT03464227
Start Date
February 16 2018
End Date
December 1 2018
Last Update
December 12 2018
Active Locations (1)
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1
Up0047 001
Berlin, Germany