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

UCB

Status and phase: Completed; Phase 1

Conditions: Healthy Male Volunteers

Treatments: Other: Placebo; Drug: UCB0107

Study type: Interventional

Funder types: Industry

Identifiers

NCT03464227

2017-003315-19 (EudraCT Number)

UP0047

Details and patient eligibility

About

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.

Enrollment: 52 patients

Sex: Male

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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52 participants in 2 patient groups, including a placebo group

UCB0107

Experimental group

Description:

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.

Treatment:

Drug: UCB0107

Placebo

Placebo Comparator group

Description:

Subjects randomized to this arm will receive matching Placebo to UCB0107. This arm will consist of a maximum of 7 cohorts.

Treatment:

Other: Placebo