A Study to Evaluate Safety, Tolerability, and Pharmacokinetics of a Single Dose of Donzakimig in Healthy Chinese and Japanese Participants

Launched by UCB BIOPHARMA SRL · Nov 29, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new medication called donzakimig to see how safe it is and how well it works in healthy adults from Chinese and Japanese backgrounds. The researchers will give participants a single dose of the medication and monitor them for any side effects and how their bodies process the drug. The study is currently looking for healthy adults aged 18 to 55 who are of Chinese or Japanese descent and meet certain health criteria.

To be eligible, participants should not have serious allergies, recent infections, or certain medical conditions like diabetes or inflammatory bowel disease. Individuals who have received specific vaccinations recently or who have participated in other studies may not qualify. Those who join the trial can expect to undergo health evaluations and will be closely monitored during the study. This is an important step in understanding how donzakimig may be used in the future.

Gender

ALL

Eligibility criteria

• • Inclusion criteria
• • Study participant must be 18 to 55 years of age inclusive at the time of signing the informed consent form (ICF)
• • Study participant who is overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac assessment
• • Chinese study participant who is of Chinese descent as evidenced in appearance and verbal confirmation of familial heritage and is of Chinese descent with all 4 grandparents, OR Japanese study participant who is of Japanese descent as evidenced in appearance and verbal confirmation of familial heritage and is of Japanese descent with all 4 grandparents
• • Study participant has a body mass index within the range of 18 to 30kg/m2 (inclusive)
• • Study participant can be male or female
• • Exclusion criteria
• • Study participant has clinically significant multiple or severe drug allergies (including to humanized monoclonal antibodyies (mAbs), intolerance to topical corticosteroids, severe post-treatment hypersensitivity reactions (including, but not limited to, erythema multiforme major, linear immunoglobulin A dermatosis, toxic epidermal necrolysis, and exfoliative dermatitis), known relevant allergy (not including mild seasonal hay fever and/or conjunctivitis or low grade food intolerances), pre-existing history of a relevant allergic condition, or a predisposition for an allergic reaction, as judged by the Investigator
• • Study participant has a recent history (within 6 months prior to Screening) or currently active clinically-significant bacterial, fungal, endoparasite (including the presence of ova, cysts, or parasites detected in stool sample provided at Screening), or viral (including hospitalization for coronavirus disease 2019 \[COVID-19\]) infection, as judged by the Investigator
• • Study participant has a history of inflammatory bowel disease (eg, Crohn's disease or ulcerative colitis)
• • Study participant has a history of diabetes
• • Study participant has received any vaccination within 8 weeks for live vaccines (including attenuated) and 4 weeks for nonlive vaccines prior to the Baseline Visit or is anticipated to do so within 60 days after the dose of IMP
• • Study participant has received Bacillus Calmette-Guerin vaccinations within 1 year prior to the Baseline Visit or will receive them within 90 days after the dose of IMP
• • Study participant has participated in another study of an IMP or has received any biologic agent within the 30 days prior to Screening (or 5 half-lives, whichever is longer)
• • Study participant has had a positive human immunodeficiency virus (HIV) antibody test
• • Study participant has the presence of either hepatitis B core antibody or hepatitis B surface antigen at Screening or within 3 months prior to dosing
• • Study participant has a positive hepatitis C antibody test result at Screening or within 3 months prior to Screening.
• • Study participant has a positive hepatitis C ribonucleic acid (RNA) test result at Screening or within 3 months prior to Screening