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

NCT06716879 | Completed Phase 1 FDA Drug

• 1 other identifier: UP0142
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Participants

Keywords

donzakimig; UCB1381; Phase 1; Healthy Participants

Outcome Measures

Primary Outcomes (5)

• Occurrence of treatment-emergent adverse events (TEAEs)

  An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. Treatment emergent adverse events (TEAEs) are adverse events not present prior to the pharmaceutical product administration or an already present event that worsens either in intensity or frequency

  From Baseline to End of Study visit (up to Day 57)

• Occurrence of serious treatment-emergent adverse events (serious TEAEs)

  A serious treatment-emergent adverse event (serious TEAE) is defined as any untoward medical occurrence that, at any dose: Results in death Is life-threatening Requires inpatient hospitalization or prolongation of existing hospitalization Results in persistent disability/incapacity Is a congenital anomaly/birth defect Important medical events

  From Baseline to End of Study visit (up to Day 57)

• Maximum plasma concentration (Cmax) of donzakimig

  Cmax: Maximum plasma concentration of donzakimig

  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.

• Area under the plasma concentration-time curve from time 0 to t of donzakimig

  AUC0-t: Area under the plasma concentration-time curve from from 0 to the time (t) of the last quantifiable concentration.

  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.

• Area under the plasma concentration-time curve from zero to infinity of donzakimig

  AUC: Area under the plasma concentration-time curve from zero to infinity of donzakimig

  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.

Study Arms (8)

Low Dose of donzakimig in Chinese participants

EXPERIMENTAL

Chinese participants will be randomized to receive a predefined dosage of donzakimig.

Drug: Donzakimig

High Dose of donzakimig in Chinese participants

EXPERIMENTAL

Chinese participants will be randomized to receive a predefined dosage of donzakimig.

Drug: Donzakimig

Low Dose of placebo in Chinese participants

PLACEBO COMPARATOR

Chinese participants will be randomized to receive a predefined dosage of placebo.

Drug: Placebo

High Dose of placebo in Chinese participants

PLACEBO COMPARATOR

Chinese participants will be randomized to receive a predefined dosage of placebo.

Drug: Placebo

Low Dose of donzakimig in Japanese participants

EXPERIMENTAL

Japanese participants will be randomized to receive a predefined dosage of donzakimig.

Drug: Donzakimig

High Dose of donzakimig in Japanese participants

EXPERIMENTAL

Japanese participants will be randomized to receive a predefined dosage of donzakimig.

Drug: Donzakimig

Low Dose of placebo in Japanese participants

PLACEBO COMPARATOR

Japanese participants will be randomized to receive a predefined dosage of placebo.

Drug: Placebo

High Dose of placebo in Japanese participants

PLACEBO COMPARATOR

Japanese participants will be randomized to receive a predefined dosage of placebo.

Drug: Placebo

Interventions

Donzakimig DRUG

Drug: Donzakimig Pharmaceutical form: Subcutaneous solution

Also known as: UCB1381

High Dose of donzakimig in Chinese participants; High Dose of donzakimig in Japanese participants; Low Dose of donzakimig in Chinese participants; Low Dose of donzakimig in Japanese participants

Placebo DRUG

Drug: Placebo Pharmaceutical form: Subcutaneous solution

High Dose of placebo in Chinese participants; High Dose of placebo in Japanese participants; Low Dose of placebo in Chinese participants; Low Dose of placebo in Japanese participants

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• UCB Biopharma SRL: lead

Study Sites (1)

UP0142 1

Anaheim, California, 92801, United States

Location

Study Officials

• UCB Cares

  0018445992273

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 29, 2024
• First Posted: December 4, 2024
• Study Start: December 6, 2024
• Primary Completion: April 4, 2025
• Study Completion: April 4, 2025
• Last Updated: February 18, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)