Healthy ParticipantsPhase 1NCT06716879
A Study to Evaluate Safety, Tolerability, and Pharmacokinetics of a Single Dose of Donzakimig in Healthy Chinese and Japanese Participants
A Phase 1 study testing Donzakimig in people with Healthy Participants, run by UCB Biopharma SRL at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants
- What is being tested?
- Donzakimig
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Dec 2024to 4 Apr 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Being tested
- Donzakimig, Placebo
- Keywords
- donzakimig, UCB1381, Phase 1, Healthy Participants
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DonzakimigDrug
Also called UCB1381
Drug: Donzakimig Pharmaceutical form: Subcutaneous solution
PlaceboDrug
Drug: Placebo Pharmaceutical form: Subcutaneous solution
| Study group | Role | What they receive |
|---|---|---|
| Low Dose of donzakimig in Chinese participants | Experimental | Chinese participants will be randomized to receive a predefined dosage of donzakimig. Receives: Drug: Donzakimig |
| High Dose of donzakimig in Chinese participants | Experimental | Chinese participants will be randomized to receive a predefined dosage of donzakimig. Receives: Drug: Donzakimig |
| Low Dose of placebo in Chinese participants | Placebo comparator | Chinese participants will be randomized to receive a predefined dosage of placebo. Receives: Drug: Placebo |
| High Dose of placebo in Chinese participants | Placebo comparator | Chinese participants will be randomized to receive a predefined dosage of placebo. Receives: Drug: Placebo |
| Low Dose of donzakimig in Japanese participants | Experimental | Japanese participants will be randomized to receive a predefined dosage of donzakimig. Receives: Drug: Donzakimig |
| High Dose of donzakimig in Japanese participants | Experimental | Japanese participants will be randomized to receive a predefined dosage of donzakimig. Receives: Drug: Donzakimig |
| Low Dose of placebo in Japanese participants | Placebo comparator | Japanese participants will be randomized to receive a predefined dosage of placebo. Receives: Drug: Placebo |
| High Dose of placebo in Japanese participants | Placebo comparator | Japanese participants will be randomized to receive a predefined dosage of placebo. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: From Baseline to End of Study visit (up to Day 57)
Maximum plasma concentration (Cmax) of donzakimig
Cmax: Maximum plasma concentration of donzakimig
Measured: 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.
Measured: 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
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2024
- Study start6 Dec 2024
- Primary completion4 Apr 2025
- Study completion4 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy ParticipantsStudies of the same condition, open and under way.
- More trials run by UCB Biopharma SRLThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- UCB Biopharma SRL
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- UCB Cares, Study director, 0018445992273
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06716879
- Sponsor's protocol ID
- UP0142
- Status last verified
- Feb 2026
- First submitted
- 29 Nov 2024
- Last updated
- 18 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Due to the small sample size in this trial, IPD cannot be adequately anonymized i.e., there is a reasonable likelihood that individual participants could be re-identified. For this reason, data from this trial cannot be shared.
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06716879
- Acronym / sponsor ID
- UP0142
- Conditions
- Healthy Participants
- Keywords
- donzakimig, UCB1381, Phase 1, Healthy Participants
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- UCB Biopharma SRLIndustry (pharma, biotech, devices)
- Study start
- 6 Dec 2024 (actual)
- Primary completion
- 4 Apr 2025 (actual)
- Study completion
- 4 Apr 2025 (actual)
- First posted
- 4 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Low Dose of donzakimig in Chinese participants | Experimental | Drug: DonzakimigChinese participants will be randomized to receive a predefined dosage of donzakimig. |
| High Dose of donzakimig in Chinese participants | Experimental | Drug: DonzakimigChinese participants will be randomized to receive a predefined dosage of donzakimig. |
| Low Dose of placebo in Chinese participants | Placebo comparator | Drug: PlaceboChinese participants will be randomized to receive a predefined dosage of placebo. |
| High Dose of placebo in Chinese participants | Placebo comparator | Drug: PlaceboChinese participants will be randomized to receive a predefined dosage of placebo. |
| Low Dose of donzakimig in Japanese participants | Experimental | Drug: DonzakimigJapanese participants will be randomized to receive a predefined dosage of donzakimig. |
| High Dose of donzakimig in Japanese participants | Experimental | Drug: DonzakimigJapanese participants will be randomized to receive a predefined dosage of donzakimig. |
| Low Dose of placebo in Japanese participants | Placebo comparator | Drug: PlaceboJapanese participants will be randomized to receive a predefined dosage of placebo. |
| High Dose of placebo in Japanese participants | Placebo comparator | Drug: PlaceboJapanese participants will be randomized to receive a predefined dosage of placebo. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DonzakimigAlso: UCB1381Drug: Donzakimig Pharmaceutical form: Subcutaneous solution | Drug | 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 |
| PlaceboDrug: Placebo Pharmaceutical form: Subcutaneous solution | Drug | 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 |
Primary outcome
Occurrence of treatment-emergent adverse events (TEAEs)
Time frame: From Baseline to End of Study visit (up to Day 57)
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
Occurrence of serious treatment-emergent adverse events (serious TEAEs)
Time frame: From Baseline to End of Study visit (up to Day 57)
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
Maximum plasma concentration (Cmax) of donzakimig
Time frame: 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.
Cmax: Maximum plasma concentration of donzakimig
Area under the plasma concentration-time curve from time 0 to t of donzakimig
Time frame: 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.
AUC0-t: Area under the plasma concentration-time curve from from 0 to the time (t) of the last quantifiable concentration.
Area under the plasma concentration-time curve from zero to infinity of donzakimig
Time frame: 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.
AUC: Area under the plasma concentration-time curve from zero to infinity of donzakimig
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2026.
- Individual participant dataSharing planned: No. Due to the small sample size in this trial, IPD cannot be adequately anonymized i.e., there is a reasonable likelihood that individual participants could be re-identified. For this reason, data from this trial cannot be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
UCB Cares study director
0018445992273
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Donzakimig in people with Healthy Participants, run by UCB Biopharma SRL at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of treatment-emergent adverse events (TEAEs) (time frame: From Baseline to End of Study visit (up to Day 57)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2026.