A Study to Test the Safety, Pharmacokinetics, and Pharmacodynamics of Single Ascending Intravenous Doses of UCB0107 in Healthy Male Subjects
- Registration Number
- NCT03464227
- Lead Sponsor
- UCB Biopharma S.P.R.L.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 52
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description UCB0107 UCB0107 Subjects randomized to this arm will receive UCB0107. This arm will consist of a maximum of 7 cohorts. The dose for cohort 1 will be fixed, proposed doses for cohorts 2,3,4,5,6 and 7 may be adapted based upon recommendation by the Safety Review Group. Placebo Placebo Subjects randomized to this arm will receive matching Placebo to UCB0107. This arm will consist of a maximum of 7 cohorts.
- Primary Outcome Measures
Name Time Method The incidence of Adverse Events (AEs) during the study During the study from Visit 1 up to the Safety Follow-Up Visit (Week 20) An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
- Secondary Outcome Measures
Name Time Method The terminal half-life (t½) of UCB0107 in serum Pharmacokinetic samples will be taken at pre-defined time points throughout study completion (up to Week 20) t1/2: terminal half-life
CSF/serum ratio of antibody concentrations Pharmacokinetic samples and samples from cerebrospinal fluid will be taken at pre-defined time points throughout study completion (up to Week 20) Ratio of the antibody concentrations in cerebrospinal fluid and serum
The time to maximum concentration (tmax) for UCB0107 in serum and cerebrospinal fluid Pharmacokinetic samples and samples from cerebrospinal fluid will be taken at pre-defined time points throughout study completion (up to Week 20) tmax: time to maximum observed serum concentration
The Maximum concentration (Cmax) for UCB0107 in serum and cerebrospinal fluid Pharmacokinetic samples and samples from cerebrospinal fluid will be taken at pre-defined time points throughout study completion (up to Week 20) Cmax: maximum observed serum concentration
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 Pharmacokinetic samples and samples from cerebrospinal fluid will be taken at pre-defined time points throughout study completion (up to Week 20) AUC(0-t): area under the concentration-time curve from time 0 to time t, the time of the last quantifiable concentration
The volume of distribution (Vz) for UCB0107 in serum Pharmacokinetic samples will be taken at pre-defined time points throughout study completion (up to Week 20) Vz: volume of distribution.
The total Clearance (CL) for UCB0107 in serum Pharmacokinetic samples will be taken at pre-defined time points throughout study completion (up to Week 20) CL: clearance
The area under the concentration-time curve from time 0 to infinity (AUC) in serum and cerebrospinal fluid Pharmacokinetic samples and samples from cerebrospinal fluid will be taken at pre-defined time points throughout study completion (up to Week 20) AUC: area under the concentration-time curve from time 0 to infinity
Trial Locations
- Locations (1)
Up0047 001
🇩🇪Berlin, Germany