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

Active, not 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:

金禾娱乐城1381

Other Descriptive Name:

金禾娱乐城1381

Placebo

Yes

Comparator:

No

Study Dates

December 2024

Actual Start Date of Enrollment

April 2025

Planned Study Completion Date

General Information

Study ID:
UP0142
CT.gov Number:
Phase:
Phase 1

Locations

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