A Study to Test the Safety, Pharmacokinetics, and Pharmacodynamics of Single Ascending Intravenous Doses of UCB0107 in Healthy Male Subjects
Sponsored by UCB Biopharma S.P.R.L.
About this trial
Last updated 7 years ago
Study ID
Status
Type
Phase
Placebo
Accepting
Trial Timing
Ended 7 years ago
What is this trial about?
What are the participation requirements?
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