UP0142 A Single-Center, Randomized, Investigator- and Participant-Blind, Placebo-Controlled, Phase 1 Study to Evaluate Safety, Tolerability, and Pharmacokinetics After a Single Dose of Donzakimig in Healthy Chinese and Japanese Participants Brief summary The purpose of the study is to investigate the safety, tolerability, and pharmacokinetic parameters of 2 dose strengths of donzakimig, each administered subcutaneously as a single dose, in healthy Chinese and Japanese study participants. Medical Condition Healthy Participants Min. Age 18 Years Max. Age 55 Years Who Can Join? All Status Recruiting Inclusion 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 Exclusion 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 Study Medication Description Study Medication: UCB1381 Other Descriptive Name: UCB1381 Placebo Yes Comparator: No Share this study Share Facebook Share Twitter Share LinkedIn Refer to a friend Via email Study Dates December 2024 Actual Start Date of Enrollment March 2025 Planned Study Completion Date General Information Study ID: UP0142 CT.gov Number: NCT06716879 Phase: Phase 1 Locations Click here to find out where the clinical study is conducted Interested in our clinical studies? 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