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

NCT ID: NCT03464227

Last Updated: 2018-12-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-02-16
• Study Completion Date: 2018-12-01

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.

Conditions

Healthy Male Volunteers

Keywords

Phase 1; UCB0107

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

UCB0107

Intervention Type: DRUG

• Pharmaceutical form: solution for infusion
• Route of administration: intravenous use

Placebo

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

• Pharmaceutical form: intravenous infusion
• Route of administration: intravenous use

Interventions

UCB0107

• Pharmaceutical form: solution for infusion
• Route of administration: intravenous use

Intervention Type: DRUG

Placebo

• Pharmaceutical form: intravenous infusion
• Route of administration: intravenous use

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

UCB Biopharma S.P.R.L.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

UCB Cares

Role: STUDY_DIRECTOR

001 844 599 2273 (UCB)

Locations

Up0047 001

Berlin, , Germany

Countries

Germany

Other Identifiers

2017-003315-19

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

UP0047

Identifier Type: -

Identifier Source: org_study_id