Clinical trial NCT06716879: A Study to Evaluate Safety, Tolerability, and Pharmacokinetics of a Single Dose of Donzakimig in Healthy Chinese and Japanese Participants
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Participants
Keywords: donzakimig
UCB1381
Phase 1
Healthy Participants
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2024-12-04
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


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

Primary outcomes:
measure: Occurrence of treatment-emergent adverse events (TEAEs)
timeFrame: From Baseline to End of Study visit (up to Day 57)
measure: Occurrence of serious treatment-emergent adverse events (serious TEAEs)
timeFrame: From Baseline to End of Study visit (up to Day 57)
measure: Maximum plasma concentration (Cmax) of donzakimig
timeFrame: Sampling timepoints will be on Day 1 (D1): at predose and 6 hours (h), 24h (D2), 72h (D4), 120h (D6), D8, D15, D22, D36, and D57 after investigational medicinal product (IMP) administration.
measure: Area under the plasma concentration-time curve from time 0 to t of donzakimig
timeFrame: Sampling timepoints will be on Day 1 (D1): at predose and 6 hours (h), 24h (D2), 72h (D4), 120h (D6), D8, D15, D22, D36, and D57 after investigational medicinal product (IMP) administration.
measure: Area under the plasma concentration-time curve from zero to infinity of donzakimig
timeFrame: Sampling timepoints will be on Day 1 (D1): at predose and 6 hours (h), 24h (D2), 72h (D4), 120h (D6), D8, D15, D22, D36, and D57 after investigational medicinal product (IMP) administration.
Secondary outcomes:
Other outcomes:
Locations:
city: Anaheim
country: United States
facility: UP0142 1
state: California
Study officials:
affiliation: 0018445992273
name: UCB Cares
role: STUDY_DIRECTOR
References: