A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of UCB0942 in Healthy Japanese and Caucasian Subjects

UCB

Status and phase: Completed; Phase 1

Conditions: Healthy Japanese and Caucasian Subjects

Treatments: Drug: UCB0942; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT03168984

UP0039

2017-000385-30 (EudraCT Number)

Details and patient eligibility

About

The purpose of the study is to evaluate the pharmacokinetics, safety and tolerability of UCB0942 in Japanese and Caucasian subjects.

Enrollment: 48 patients

Sex: All

Ages: 20 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Subject is male or female and between 20 and 55 years of age (inclusive)
• Subject is in good physical and mental health
• Female subjects will use an efficient form of contraception for the duration of the study (unless menopausal)
• Male subject agrees that, during the study period, when having sexual intercourse with a woman of childbearing potential, he will use an efficient barrier contraceptive AND that the respective partner will use an additional efficient contraceptive method
• For Japanese subjects: Subject is of Japanese descent as evidenced by appearance and verbal confirmation of familial heritage (a subject has all 4 Japanese grandparents born in Japan)
• For Caucasians: Subject is of Caucasian descent as evidenced by appearance and verbal confirmation of familial heritage (a subject has 4 Caucasian grandparents).

Exclusion criteria

At screening:

• Previous study participation with another investigational medicinal product (IMP) within 3 months
• History of alcohol/drug abuse
• History of psychiatric condition and suicide attempt
• Any medical condition unfit for study (including history of cancer)
• History of hypersensitivity for IMP components
• Taking concomitant medications
• Positive for human immunodeficiency virus (HIV)/ hepatitis B virus (HBV)/ hepatitis C virus (HCV)
• Abnormal liver function tests (LFTs), abnormal safety bloods/ vitals/ physical examination and electrocardiogram (ECG) findings
• Positive for pregnancy test
• Other protocol-defined exclusion criteria may apply

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

48 participants in 2 patient groups, including a placebo group

UCB0942

Experimental group

Description:

Cohort 1 (Japanese subjects): Single dose of UCB0942 (dosage regimen 1) Cohort 2 (Japanese subjects): Single dose of UCB0942 (dosage regimen 2) Cohort 3 (Japanese subjects): Single dose of UCB0942 (dosage regimen 3) followed, after maximum 21 days, by multiple doses of UCB0942 (dosage regimen 2) Cohort 4 (Caucasian subjects): Single dose of UCB0942 (dosage regimen 3) followed, after maximum 21 days, by multiple doses of UCB0942 (dosage regimen 2)

Treatment:

Drug: UCB0942

Placebo

Placebo Comparator group

Description:

Cohort 1 and Cohort 2: Single dose of Placebo Cohort 3 and Cohort 4: Single dose of Placebo followed, after maximum 21 days, by multiple doses of Placebo

Treatment:

Other: Placebo