Safety and Blood Levels After a Single Injection of UPB-101 in Healthy Japanese and Non-Japanese Non-East Asian Adults

Main Inclusion Criteria:

• Male or female, aged ≥18 to ≤40 years at the date of signing informed consent
• Body mass index (BMI) between 18 and 25 kg/m2
• For Japanese (treatment groups 1, 2 and 3), participants must be:
• Born in Japan, holding a Japanese passport,
• Not living outside Japan for more than 5 years at the date of signing informed consent,
• Have all 4 grandparents Japanese

For NJNEA treatment group 4, participants must be:

• Non-Japanese,
• Non-East Asian (Chinese, Korean, Mongolian or Taiwanese).
• Healthy, as defined by:
• The absence of clinically significant illness and surgery within 4 weeks prior to dosing.
• The absence of clinically significant history of neurological, endocrine, cardiovascular, respiratory, haematological, immunological, psychiatric, gastrointestinal, renal, hepatic, and metabolic disease.
• Agrees to follow the required contraceptive techniques.
• Agrees not to donate sperm or ova from the time of the administration of study medication until three months later (120 days)

Main Exclusion Criteria:

• Current or recurrent disease (or condition), which may put the participant at risk, influence the results of the study, or otherwise affect their ability to participate in the study.
• Vital signs consistently outside the normal range at Screening or Day -1 and any other abnormal findings or vital signs, ECG, telemetry, physical examination or laboratory evaluation of blood and urine samples that the Investigator judges as likely to interfere with the study or pose an additional risk in participating.
• Previous exposure or current infection with Hepatitis B, Hepatitis C, tuberculosis (TB), other active recent infection, or history of any untreated or unresolved infection, including parasitic infection.
• Pregnant or breastfeeding female.
• Previous exposure to the study drug or known allergy/sensitivity to any of its ingredients.
• Positive test results for alcohol or drugs of abuse (including cotinine) at Screening or Day -1, or history or clinical evidence of substance and/or alcohol abuse within 2 years before screening.
• Use of tobacco or other nicotine-containing products in any form within 3 months prior to Day 1.
• Any recent vaccination, prescription or over-the-counter medication, including herbal remedies or dietary supplements.
• Recent donation of blood or blood products.