Healthy ParticipantsPhase 1NCT07286682
A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of UCB5285 in Healthy Study Participants
A Phase 1 study testing UCB5285 in people with Healthy Participants, run by UCB Biopharma SRL at 1 site in United Kingdom.
Trial summary
The purpose of this study is to evaluate the safety and tolerability of single ascending doses of UCB5285 in healthy study participants, including healthy 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?
- UCB5285
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 8 Dec 2025to 13 Dec 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 study participants of Japanese origin: study participant who is born in Japan and of Japanese descent as evidenced in appearance and verbal confirmation of familial heritage with all 4 grandparents and both parents born in Japan and has not had a significant change in lifestyle or diet since leaving Japan
- For all study participants:
- Study participant must be 18 to 55 years of age, inclusive, at the time of signing the informed consent
- Study participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring.
- Body weight within 40 kilograms (kg) to 110 kg and body mass index (BMI) within the range of 18 kilograms per meter square (kg/m2) to 30 kg/m2 (inclusive)
Who cannot join
- Study participant has a history or presence of any medical or psychiatric condition, physical examination finding, laboratory test result, electrocardiogram (ECG), or vital sign that, in the opinion of the investigator, could significantly alter the absorption, or elimination of drugs; constitute a risk when taking the study intervention; or interfere with the interpretation of data
- Study participant has a recent history (within 6 months of Screening) or currently active clinically significant bacterial, fungal, endoparasite, or viral infection.
- Study participant has a significant allergy to humanized monoclonal antibody (mAbs)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Randomized, Placebo-Controlled Single Ascending Dose Participant- and Investigator-Blind Study to Investigate the Safety, Tolerability, and Pharmacokinetics of UCB5285 in Healthy Study Participants
The purpose of this study is to evaluate the safety and tolerability of single ascending doses of UCB5285 in healthy study participants, including healthy Japanese study participants
- Conditions
- Healthy Participants
- Being tested
- UCB5285, Placebo
- Keywords
- UCB5285
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UCB5285Drug
Participants will receive UCB5285 as prespecified in each cohort.
PlaceboOther
Participants will receive matching placebo as prespecified in each cohort.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | Participants randomized to this arm will receive a single dose of UCB5285 (Dose 1) or placebo via Route of Administration 1. Receives: Drug: UCB5285; Other: Placebo |
| Cohort 2 | Experimental | Participants randomized to this arm will receive a single dose of UCB5285 (Dose 2) or placebo via Route of Administration 1. Receives: Drug: UCB5285; Other: Placebo |
| Cohort 3 | Experimental | Participants randomized to this arm will receive a single dose of UCB5285 (Dose 3) or placebo via Route of Administration 1. Receives: Drug: UCB5285; Other: Placebo |
| Cohort 4 | Experimental | Participants randomized to this arm will receive a single dose of UCB5285 (Dose 4) or placebo via Route of Administration 1. Receives: Drug: UCB5285; Other: Placebo |
| Cohort 5 | Experimental | Participants randomized to this arm will receive a single dose of UCB5285 (Dose 4) or placebo Route of Administration 2. Receives: Drug: UCB5285; Other: Placebo |
| Cohort 6 | Experimental | Participants randomized to this arm will receive a single dose of UCB5285 (Dose 5) or placebo via Route of Administration 1. Receives: Drug: UCB5285; Other: Placebo |
| Cohort 7 | Experimental | Participants randomized to this arm will receive a single dose of UCB5285 (Dose 5) or placebo via Route of Administration 2. Receives: Drug: UCB5285; Other: Placebo |
| Cohort 8 | Experimental | Participants randomized to this arm will receive a single dose of UCB5285 (Dose 6) or placebo via Route of Administration 1. Receives: Drug: UCB5285; Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment-Emergent Adverse Events (TEAEs)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Treatment emergent adverse events (TEAEs) are adverse events that are not present prior to the pharmaceutical product administration or an already present event that worsens either in intensity or frequency.
Measured: From Day 1 to the End Of Study (up to Day 161)
Incidence of Treatment-Emergent Serious Adverse Events (SAEs)
An SAE is defined as any untoward medical occurrence that, at any dose, meets 1 or more of the criteria listed:
- Results in death
- Is life-threatening
- Requires inpatient hospitalization or prolongation of existing hospitalization
- Results in persistent or significant disability/incapacity
- 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 Day 1 to the End Of Study (up to Day 161)
Secondary outcomes (3)
Maximum Observed Serum Concentration (Cmax) of UCB5285
Maximum observed serum concentration (Cmax) of UCB5285
Measured: From Day 1 (Predose) at predefined time points up to Day 161
Area Under the Serum Concentration-Time Curve From Time Zero to Infinity (AUC) of UCB5285
Area under the serum concentration-time curve from time zero to infinity (AUC) of UCB5285
Measured: From Day 1 (Predose) at predefined time points up to Day 161
Area Under the Serum Concentration-Time Curve from Time Zero to the Time of Last Detectable Concentration (AUC0-t) of UCB5285
Area under the serum concentration-time curve from time zero to the time of last detectable concentration (AUC0-t) of UCB5285
Measured: From Day 1 (Predose) at predefined time points up to Day 161
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2025
- Study start8 Dec 2025
- Primary completion13 Dec 2026 (estimated)
- Study completion13 Dec 2026 (estimated)
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
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- UCB Biopharma SRL
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- UCB Cares, Study director, 001 844 599 2273 (UCB)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07286682
- Sponsor's protocol ID
- UP0161
- Status last verified
- Jul 2026
- First submitted
- 3 Dec 2025
- Last updated
- 24 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Due to the small sample size in this trial, individual participant-level data cannot be adequately anonymized as 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 24 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Placebo-Controlled Single Ascending Dose Participant- and Investigator-Blind Study to Investigate the Safety, Tolerability, and Pharmacokinetics of UCB5285 in Healthy Study Participants
- ClinicalTrials.gov ID
- NCT07286682
- Acronym / sponsor ID
- UP0161
- Conditions
- Healthy Participants
- Keywords
- UCB5285
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 80 participants (actual)
- Lead sponsor
- UCB Biopharma SRLIndustry (pharma, biotech, devices)
- Study start
- 8 Dec 2025 (actual)
- Primary completion
- 13 Dec 2026 (estimated)
- Study completion
- 13 Dec 2026 (estimated)
- First posted
- 16 Dec 2025 (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 this study is to evaluate the safety and tolerability of single ascending doses of UCB5285 in healthy study participants, including healthy Japanese study participants
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: UCB5285, Other: PlaceboParticipants randomized to this arm will receive a single dose of UCB5285 (Dose 1) or placebo via Route of Administration 1. |
| Cohort 2 | Experimental | Drug: UCB5285, Other: PlaceboParticipants randomized to this arm will receive a single dose of UCB5285 (Dose 2) or placebo via Route of Administration 1. |
| Cohort 3 | Experimental | Drug: UCB5285, Other: PlaceboParticipants randomized to this arm will receive a single dose of UCB5285 (Dose 3) or placebo via Route of Administration 1. |
| Cohort 4 | Experimental | Drug: UCB5285, Other: PlaceboParticipants randomized to this arm will receive a single dose of UCB5285 (Dose 4) or placebo via Route of Administration 1. |
| Cohort 5 | Experimental | Drug: UCB5285, Other: PlaceboParticipants randomized to this arm will receive a single dose of UCB5285 (Dose 4) or placebo Route of Administration 2. |
| Cohort 6 | Experimental | Drug: UCB5285, Other: PlaceboParticipants randomized to this arm will receive a single dose of UCB5285 (Dose 5) or placebo via Route of Administration 1. |
| Cohort 7 | Experimental | Drug: UCB5285, Other: PlaceboParticipants randomized to this arm will receive a single dose of UCB5285 (Dose 5) or placebo via Route of Administration 2. |
| Cohort 8 | Experimental | Drug: UCB5285, Other: PlaceboParticipants randomized to this arm will receive a single dose of UCB5285 (Dose 6) or placebo via Route of Administration 1. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- For study participants of Japanese origin: study participant who is born in Japan and of Japanese descent as evidenced in appearance and verbal confirmation of familial heritage with all 4 grandparents and both parents born in Japan and has not had a significant change in lifestyle or diet since leaving Japan
- For all study participants:
- Study participant must be 18 to 55 years of age, inclusive, at the time of signing the informed consent
- Study participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring.
- Body weight within 40 kilograms (kg) to 110 kg and body mass index (BMI) within the range of 18 kilograms per meter square (kg/m2) to 30 kg/m2 (inclusive)
Key exclusion criteria (3 listed)
- Study participant has a history or presence of any medical or psychiatric condition, physical examination finding, laboratory test result, electrocardiogram (ECG), or vital sign that, in the opinion of the investigator, could significantly alter the absorption, or elimination of drugs; constitute a risk when taking the study intervention; or interfere with the interpretation of data
- Study participant has a recent history (within 6 months of Screening) or currently active clinically significant bacterial, fungal, endoparasite, or viral infection.
- Study participant has a significant allergy to humanized monoclonal antibody (mAbs)
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 |
|---|---|---|
| UCB5285Participants will receive UCB5285 as prespecified in each cohort. | Drug | Cohort 1, Cohort 2, Cohort 3, Cohort 4, Cohort 5, Cohort 6, Cohort 7, Cohort 8 |
| PlaceboParticipants will receive matching placebo as prespecified in each cohort. | Other | Cohort 1, Cohort 2, Cohort 3, Cohort 4, Cohort 5, Cohort 6, Cohort 7, Cohort 8 |
Primary outcome
Incidence of Treatment-Emergent Adverse Events (TEAEs)
Time frame: From Day 1 to the End Of Study (up to Day 161)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Treatment emergent adverse events (TEAEs) are adverse events that are not present prior to the pharmaceutical product administration or an already present event that worsens either in intensity or frequency.
Incidence of Treatment-Emergent Serious Adverse Events (SAEs)
Time frame: From Day 1 to the End Of Study (up to Day 161)
An SAE is defined as any untoward medical occurrence that, at any dose, meets 1 or more of the criteria listed: * Results in death * Is life-threatening * Requires inpatient hospitalization or prolongation of existing hospitalization * Results in persistent or significant disability/incapacity * 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
Maximum Observed Serum Concentration (Cmax) of UCB5285
Time frame: From Day 1 (Predose) at predefined time points up to Day 161
Area Under the Serum Concentration-Time Curve From Time Zero to Infinity (AUC) of UCB5285
Time frame: From Day 1 (Predose) at predefined time points up to Day 161
Area Under the Serum Concentration-Time Curve from Time Zero to the Time of Last Detectable Concentration (AUC0-t) of UCB5285
Time frame: From Day 1 (Predose) at predefined time points up to Day 161
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2026.
- Individual participant dataSharing planned: No. Due to the small sample size in this trial, individual participant-level data cannot be adequately anonymized as 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
001 844 599 2273 (UCB)
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 UCB5285 in people with Healthy Participants, run by UCB Biopharma SRL at 1 site in United Kingdom.
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 3 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: under way, not looking for participants, as of the sponsor's last update on 24 Jul 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 Kingdom. 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?
This study is still under way. Results are not available in the source record yet.
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?
Incidence of Treatment-Emergent Adverse Events (TEAEs) (time frame: From Day 1 to the End Of Study (up to Day 161)). 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 24 Jul 2026.