A Study to Test the Safety, Pharmacokinetics, and Pharmacodynamics of Single Ascending Intravenous Doses of UCB0107 in Healthy Male Subjects

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Healthy Male Volunteers

Intervention / Treatment
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* Drug: UCB0107
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: UCB0107<br>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. | Drug: UCB0107<br>* Pharmaceutical form: solution for infusion Route of administration: intravenous use<br>|
| Placebo Comparator: Placebo<br>Subjects randomized to this arm will receive matching Placebo to UCB0107. This arm will consist of a maximum of 7 cohorts. | Other: Placebo<br>* Pharmaceutical form: intravenous infusion Route of administration: intravenous use<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence of Adverse Events (AEs) during the study | 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. | During the study from Visit 1 up to the Safety Follow-Up Visit (Week 20) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Maximum concentration (Cmax) for UCB0107 in serum and cerebrospinal fluid | Cmax: maximum observed serum concentration | Pharmacokinetic samples and samples from cerebrospinal fluid will be taken at pre-defined time points throughout study completion (up to Week 20) | 
| The area under the concentration-time curve from time 0 to infinity (AUC) in serum and cerebrospinal fluid | AUC: area under the concentration-time curve from time 0 to infinity | Pharmacokinetic samples and samples from cerebrospinal fluid will be taken at pre-defined time points throughout study completion (up to Week 20) | 
| 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 | AUC(0-t): area under the concentration-time curve from time 0 to time t, the time of the last quantifiable concentration | Pharmacokinetic samples and samples from cerebrospinal fluid will be taken at pre-defined time points throughout study completion (up to Week 20) | 
| The time to maximum concentration (tmax) for UCB0107 in serum and cerebrospinal fluid | tmax: time to maximum observed serum concentration | Pharmacokinetic samples and samples from cerebrospinal fluid will be taken at pre-defined time points throughout study completion (up to Week 20) | 
| The terminal half-life (t½) of UCB0107 in serum | t1/2: terminal half-life | Pharmacokinetic samples will be taken at pre-defined time points throughout study completion (up to Week 20) | 
| The total Clearance (CL) for UCB0107 in serum | CL: clearance | Pharmacokinetic samples will be taken at pre-defined time points throughout study completion (up to Week 20) | 
| The volume of distribution (Vz) for UCB0107 in serum | Vz: volume of distribution. | Pharmacokinetic samples will be taken at pre-defined time points throughout study completion (up to Week 20) | 
| CSF/serum ratio of antibody concentrations | Ratio of the antibody concentrations in cerebrospinal fluid and serum | Pharmacokinetic samples and samples from cerebrospinal fluid will be taken at pre-defined time points throughout study completion (up to Week 20) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Phase 1, UCB0107