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

A Single-Centre, Investigator/Subject Blind, Placebo-Controlled, Single and Multiple Oral Dose Investigation of Safety, Tolerability, and Pharmacokinetics of UCB0942 in Healthy Japanese and Caucasian Subjects

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

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