Healthy ParticipantsPhase 1NCT06315335
A Study to Assess the Safety and Pharmacokinetics of a Single Dose of UCB9741 in Healthy Caucasian and Japanese Participants
A Phase 1 study testing UCB9741 in people with Healthy Participants, run by UCB Biopharma SRL at 1 site in United States.
Trial summary
The purpose of the study is investigate the safety, tolerability and pharmacokinetic of UCB9741 after 2 dose strengths administered subcutaneous as a single-dose in healthy Caucasian and Japanese 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?
- UCB9741
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2024to 1 Jan 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
- For all subjects:
- Male or female between 18 to 55 years old, overtly healthy
- Female participants must not be pregnant or breastfeeding
- Female participants must be either of non-childbearing potential or using a highly efficient birth control method
- Male participants must use acceptable contraception and refrain from sperm donation during the study 90 days
- Body mass Index within the range 18 to 30 kg/m^2 (inclusive)
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- For Japanese subjects only:
- Japanese descent as evidenced in appearance and verbal confirmation of familial heritage and is of Japanese descent with all 4 grandparents
- For Caucasian subjects only:
- Caucasian descent as evidenced in appearance and verbal confirmation of familial heritage and is of Caucasian descent with all 4 grandparents
Who cannot join
- Participant has a known hypersensitivity to any components of the investigational medicinal product (IMP) or other biologic drugs or humanized antibodies (mAbs)
- Participant has clinically significant multiple or severe drug allergies, intolerance to topical corticosteroids, or severe posttreatment hypersensitivity reactions
- Participant has abnormal blood pressure (BP) (outside the normal range)
- Participant has alanine aminotransferase (ALT), aspartate aminotransferase (AST), or alkaline phosphatase (ALP) >1.5x upper limit of normal (ULN)
- Participant has a recent history or currently active clinically-significant bacterial, fungal, endoparasite, or viral (including hospitalization for coronavirus disease 2019 (COVID-19)) infection (within 6 months of the Screening Visit)
- Participant has a history of inflammatory bowel disease (includes Crohn's disease and ulcerative colitis)
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- Participant has a history of diabetes
- Study participant has a corrected QT interval (QTc) >450msec for male study participants or >470msec for female study participants
- Participant has sensitivity to heparin or heparin-induced thrombocytopenia
- Participant has a positive test for substance of abuse, or is a regular alcohol consumer defined as an average weekly intake of >14 units
- Participant has received any prescription or nonprescription medicines within 14 days (or 5 half-lives of the respective drug, whichever is longer) prior to the Baseline Visit, other than contraceptives or occasional use of analgesic
- Participant has received Bacillus Calmette-Guerin vaccinations within 1 year prior to the Baseline Visit or within 90 days after the final dose of investigational medicinal product (IMP)
- Participant has been treated with biologic agents (such as mAbs, including marketed drugs) within 3 months or 5 half-lives (whichever is longer) prior to the Baseline Visit
- Participant has participated in another study of an IMP within the previous 90 days or 5 half-lives of the IMP (whichever longer), or is currently participating in another study of an IMP
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A SINGLE CENTER, RANDOMIZED, INVESTIGATOR- AND PARTICIPANT-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP, ETHNOBRIDGING PHASE 1 STUDY TO EVALUATE SAFETY, TOLERABILITY, AND PHARMACOKINETICS AFTER SINGLE-DOSE OF UCB9741 IN HEALTHY CAUCASIAN AND JAPANESE PARTICIPANTS
The purpose of the study is investigate the safety, tolerability and pharmacokinetic of UCB9741 after 2 dose strengths administered subcutaneous as a single-dose in healthy Caucasian and Japanese participants.
- Conditions
- Healthy Participants
- Being tested
- UCB9741, Placebo
- Keywords
- Phase 1, UCB9741
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UCB9741Drug
Pharmaceutical form: Solution Participants will receive UCB9741 during the Treatment Period.
PlaceboDrug
Pharmaceutical form: Solution Participants will receive Placebo during the Treatment Period.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 (Caucasian) | Experimental | Study participants enrolled in this arm will receive either injections (sc) of the lowest dose level of UCB9741 or Placebo Receives: Drug: UCB9741; Drug: Placebo |
| Cohort 2 (Japanese) | Experimental | Study participants enrolled in this arm will receive either subcutaneous (sc) injections of the lowest dose level of UCB9741 or Placebo Receives: Drug: UCB9741; Drug: Placebo |
| Cohort 3 (Caucasian) | Experimental | Study participants enrolled in this arm will receive either subcutaneous (sc) injections of the highest dose level of UCB9741 or Placebo Receives: Drug: UCB9741; Drug: Placebo |
| Cohort 4 (Japanese) | Experimental | Study participants enrolled in this arm will receive either subcutaneous (sc) injections of the highest dose level of UCB9741 or Placebo Receives: Drug: UCB9741; Drug: Placebo |
| Cohort 5 (Caucasian) | Experimental | Study participants enrolled in this arm will receive either subcutaneous (sc) injections of the highest dose level of UCB9741 (using a different volume per injection than cohort 3) or Placebo Receives: Drug: UCB9741; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of 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 pharamceutical product administration or an already present event that worsens either in intensity or frequency
Measured: From Baseline Visit up to the End of Study Visit (Week 8)
Occurrence of treatment-emergent SAEs
A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose:
Results in death Is life-threatening Requires inpatient hospitalisation or prolongation of existing hospitalisation Results in persistent or significant disability/incapacity, or Is a congenital anomaly/birth defect Other important medical events which based on medical or scientific judgement may jeopardize the patients, or may require medical or surgical intervention to prevent any of the above
Measured: From Baseline up to the End of Study Visit (Week 8)
Secondary outcomes (3)
Cmax
Cmax: Maximum serum concentration
Measured: From Day 1 (predose) up to the End of Study Visit (Week 8)
AUC0-t
AUC0-t: Area under the curve from 0 to the time of the last quantifiable concentration
Measured: From Day 1 (predose) up to the End of Study Visit (Week 8)
AUCinf
AUCinf: Area under the curve from 0 to infinity
Measured: From Day 1 (predose) up to the End of Study Visit (Week 8)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2024
- Study start1 Jul 2024
- Primary completion1 Jan 2025
- Study completion1 Jan 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- UCB Biopharma SRL
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06315335
- Sponsor's protocol ID
- UP0118
- Status last verified
- Nov 2025
- First submitted
- 11 Mar 2024
- Last updated
- 28 Nov 2025
- 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 28 Nov 2025. 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, PARALLEL-GROUP, ETHNOBRIDGING PHASE 1 STUDY TO EVALUATE SAFETY, TOLERABILITY, AND PHARMACOKINETICS AFTER SINGLE-DOSE OF UCB9741 IN HEALTHY CAUCASIAN AND JAPANESE PARTICIPANTS
- ClinicalTrials.gov ID
- NCT06315335
- Acronym / sponsor ID
- UP0118
- Conditions
- Healthy Participants
- Keywords
- Phase 1, UCB9741
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- UCB Biopharma SRLIndustry (pharma, biotech, devices)
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 1 Jan 2025 (actual)
- Study completion
- 1 Jan 2025 (actual)
- First posted
- 18 Mar 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 investigate the safety, tolerability and pharmacokinetic of UCB9741 after 2 dose strengths administered subcutaneous as a single-dose in healthy Caucasian and Japanese participants.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 (Caucasian) | Experimental | Drug: UCB9741, Drug: PlaceboStudy participants enrolled in this arm will receive either injections (sc) of the lowest dose level of UCB9741 or Placebo |
| Cohort 2 (Japanese) | Experimental | Drug: UCB9741, Drug: PlaceboStudy participants enrolled in this arm will receive either subcutaneous (sc) injections of the lowest dose level of UCB9741 or Placebo |
| Cohort 3 (Caucasian) | Experimental | Drug: UCB9741, Drug: PlaceboStudy participants enrolled in this arm will receive either subcutaneous (sc) injections of the highest dose level of UCB9741 or Placebo |
| Cohort 4 (Japanese) | Experimental | Drug: UCB9741, Drug: PlaceboStudy participants enrolled in this arm will receive either subcutaneous (sc) injections of the highest dose level of UCB9741 or Placebo |
| Cohort 5 (Caucasian) | Experimental | Drug: UCB9741, Drug: PlaceboStudy participants enrolled in this arm will receive either subcutaneous (sc) injections of the highest dose level of UCB9741 (using a different volume per injection than cohort 3) or Placebo |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Male or female between 18 to 55 years old, overtly healthy
- Female participants must not be pregnant or breastfeeding
- Female participants must be either of non-childbearing potential or using a highly efficient birth control method
- Male participants must use acceptable contraception and refrain from sperm donation during the study 90 days
- Body mass Index within the range 18 to 30 kg/m^2 (inclusive)
Key exclusion criteria (14 listed)
- Participant has a known hypersensitivity to any components of the investigational medicinal product (IMP) or other biologic drugs or humanized antibodies (mAbs)
- Participant has clinically significant multiple or severe drug allergies, intolerance to topical corticosteroids, or severe posttreatment hypersensitivity reactions
- Participant has abnormal blood pressure (BP) (outside the normal range)
- Participant has alanine aminotransferase (ALT), aspartate aminotransferase (AST), or alkaline phosphatase (ALP) >1.5x upper limit of normal (ULN)
- Participant has a recent history or currently active clinically-significant bacterial, fungal, endoparasite, or viral (including hospitalization for coronavirus disease 2019 (COVID-19)) infection (within 6 months of the Screening Visit)
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 |
|---|---|---|
| UCB9741Pharmaceutical form: Solution Participants will receive UCB9741 during the Treatment Period. | Drug | Cohort 1 (Caucasian), Cohort 2 (Japanese), Cohort 3 (Caucasian), Cohort 4 (Japanese), Cohort 5 (Caucasian) |
| PlaceboPharmaceutical form: Solution Participants will receive Placebo during the Treatment Period. | Drug | Cohort 1 (Caucasian), Cohort 2 (Japanese), Cohort 3 (Caucasian), Cohort 4 (Japanese), Cohort 5 (Caucasian) |
Primary outcome
Occurrence of TEAEs
Time frame: From Baseline Visit up to the End of Study Visit (Week 8)
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 pharamceutical product administration or an already present event that worsens either in intensity or frequency
Occurrence of treatment-emergent SAEs
Time frame: From Baseline up to the End of Study Visit (Week 8)
A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose: Results in death Is life-threatening Requires inpatient hospitalisation or prolongation of existing hospitalisation Results in persistent or significant disability/incapacity, or Is a congenital anomaly/birth defect Other important medical events which based on medical or scientific judgement may jeopardize the patients, or may require medical or surgical intervention to prevent any of the above
3 secondary outcomes
Cmax
Time frame: From Day 1 (predose) up to the End of Study Visit (Week 8)
AUC0-t
Time frame: From Day 1 (predose) up to the End of Study Visit (Week 8)
AUCinf
Time frame: From Day 1 (predose) up to the End of Study Visit (Week 8)
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 28 Nov 2025.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 UCB9741 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 10 inclusion and 14 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 28 Nov 2025. 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. 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 TEAEs (time frame: From Baseline Visit up to the End of Study Visit (Week 8)). The study lists 2 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 28 Nov 2025.