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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

UP0047

Status

Completed

Type

Interventional

Phase

Phase 1

Placebo

Yes

Accepting

18-75 Years
18 to 75 Years
Male
Male

Trial Timing

Ended 7 years ago

What is this trial 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.

What are the participation requirements?

Yes

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

No

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

Locations

Location

Status