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Healthy ParticipantsPhase 1NCT06555601

A First-in-human Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of UCB3101 in Healthy Participants

A Phase 1 study testing UCB3101 in people with Healthy Participants, run by UCB Biopharma SRL at 1 site in Belgium.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The purpose of the study is to evaluate the safety and tolerability of a single ascending dose of UCB3101 in cohorts of healthy male and female study participants. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Healthy Participants
What is being tested?
UCB3101
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
56 participants
Where
1 siteBelgium
Study dates
31 Jul 2024to 24 Nov 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 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

None listed.

Who cannot join

  • Vulnerable individuals (eg, individuals kept in detention, serving soldiers), employees of the Sponsor or the contract research organization (CRO), with direct involvement in the proposed study or other studies under the direction of the investigator or the CRO, as well as family members of the employees or the investigator
  • Participant has any medical or psychiatric condition that jeopardize or would compromise the study participant's ability to participate in this study.
  • Participant has any clinically significant Electrocardiogram (ECG) abnormalities.
  • Participant has a lifetime history of suicide attempt or has suicidal ideation in the past 6 months.
  • History or presence of clinically significant respiratory, neurological, gastrointestinal, renal, hepatic, pancreatic, hematological, cardiovascular, musculoskeletal, genitourinary, immunological, or dermatological disorders.
  • Participant has had prior history of lymphoma, leukemia, or any malignancy.
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  • Participant has a clinically significant active infection (eg, sepsis, pneumonia, abscess) or has had a serious infection within 4 weeks before the first dose of IMP.
  • Participant has had recurrent (at least 2) clinically relevant infections (eg, tooth abscess, opportunistic infections, boils, etc) in the past 6 months.
  • Participant has a history of recurrent headaches, including migraine.
  • Participant has evidence or history of significant active bleeding or coagulation disorder.
  • Participant has a history of chronic alcohol or drug abuse within 12 months prior to Baseline.
  • Participant has a history of skin disorders or extensive tattooing that prevent clear visibility of the skin in case of a hypersensitivity reaction.
  • Participant has scheduled surgery between Screening and 1 month after end of study visit.
  • Participant has a history of clinically significant back pain, back pathology, and/or back injury that may predispose participant to complications or technical difficulty with lumbar puncture (LP).
  • Participant has medical or surgical conditions for which LP is contraindicated.
  • Participant is allergic to lidocaine or its derivatives.
  • Participant has any clinically relevant brain magnetic resonance imaging (MRI) abnormality at Screening.
  • Participant has received any prescription or nonprescription medicines, including any monoclonal antibody (mAb) therapies and over the counter remedies or herbal and dietary supplements (other than vitamins within recommended daily dose limits) within 14 days (or 5 half-lives of the respective drug, whichever is longer) prior to Baseline, other than occasional use of analgesics such as paracetamol or topical nasal corticosteroids for seasonal rhinitis.
  • Participant has participated in another study of an investigational medicinal product (IMP) within 90 days (or 5 half-lives of the drug, whichever is longer) prior to Baseline or is currently participating in another study of an IMP.
  • Participant has prior exposure to any IMP specifically targeting triggering receptor expressed on myeloid cells 1 (TREM1).
  • Participant has received any live vaccination within the 8 weeks prior to Day 1 or is anticipated to do so within 120 days after the final dose of IMP.
  • Participant has any clinically relevant abnormal findings in physical examination, laboratory tests, vital signs, or ECG.
  • Participant has total bilirubin >upper limit of normal (ULN).
  • Participant has current or chronic history of liver disease or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
  • Participant has a positive urine test for substances of abuse.
  • Participant has a known active mycobacterium tuberculosis (TB) disease.
  • Participant has a known history of active TB involving any organ system unless adequately treated.
  • Participant has a positive laboratory test results for human immunodeficiency virus-1/2 antibodies), hepatitis B surface antigen, or hepatitis B core antibody result at Screening.
  • Participant has a positive hepatitis C antibody test result at Screening or within 3 months prior to Baseline.
  • Participant has clinically significant multiple or severe drug allergies, intolerance to topical corticosteroids, or severe post treatment hypersensitivity reactions (including, but not limited to, erythema multiforme major, linear immunoglobulin A dermatosis, toxic epidermal necrolysis, and exfoliative dermatitis).
  • Participant has symptomatic herpes zoster within 3 months prior to Screening.

Trial locations and contacts

1 site in 1 country.

Belgium1 site

  • UP0124 1

    Edegem

Other trials in Belgium

About this study

Official title: A First-in-Human, Randomized, Investigator-Blind, Participant-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single Ascending Doses of UCB3101 in Healthy Participants

The purpose of the study is to evaluate the safety and tolerability of a single ascending dose of UCB3101 in cohorts of healthy male and female study participants.

Being tested
UCB3101, Placebo
Keywords
UCB3101

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • UCB3101Drug

    Study participants will receive UCB3101 as prespecified in each cohort.

  • PlaceboDrug

    Study participants will receive placebo as prespecified in each cohort to maintain the blinding.

Study groups in NCT06555601
Study groupRoleWhat they receive
Cohort 1ExperimentalStudy participants randomized to this arm will receive a single dose of UCB3101 (Dose 1) or placebo.
Receives: Drug: UCB3101; Drug: Placebo
Cohort 2ExperimentalStudy participants randomized to this arm will receive a single dose of UCB3101 (Dose 2) or placebo.
Receives: Drug: UCB3101; Drug: Placebo
Cohort 3ExperimentalStudy participants randomized to this arm will receive a single dose of UCB3101 (Dose 3) or placebo.
Receives: Drug: UCB3101; Drug: Placebo
Cohort 4ExperimentalStudy participants randomized to this arm will receive a single dose of UCB3101 (Dose 4) or placebo.
Receives: Drug: UCB3101; Drug: Placebo
Cohort 5ExperimentalStudy participants randomized to this arm will receive a single dose of UCB3101 (Dose 5) or placebo.
Receives: Drug: UCB3101; Drug: Placebo
Cohort 6ExperimentalStudy participants randomized to this arm will receive a single dose of UCB3101 (Dose 6) or placebo.
Receives: Drug: UCB3101; Drug: Placebo
Cohort 7ExperimentalStudy participants randomized to this arm will receive a single dose of UCB3101 (Dose 7) or placebo.
Receives: Drug: UCB3101; Drug: Placebo
Cohort 8ExperimentalStudy participants randomized to this arm will receive a single dose of UCB3101 (Dose 8) or placebo.
Receives: Drug: UCB3101; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of any treatment- emergent adverse events (TEAE)

    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.

    Measured: From Baseline to Safety Follow-up (up to Week 21)

Secondary outcomes (4)

  1. Incidence of any treatment-emergent Serious Adverse Events (SAE)

    A Serious Adverse Event (SAE) is 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 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 to Safety Follow-up (up to Week 21)

  2. Incidence of discontinuation from treatment due to treatment- emergent adverse events (TEAE)

    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.

    Measured: From Baseline to Safety Follow-up (up to Week 21)

  3. Maximum Serum Concentration (Cmax) of UCB3101

    Maximum serum concentration (Cmax) of UCB3101 will be reported.

    Measured: From Day 1 (Predose) up to Week 21

  4. Area Under the Serum Concentration-Time Curve (AUC) of UCB3101

    Area under the serum concentration-time curve (AUC) of UCB3101 will be reported.

    Measured: From Day 1 (Predose) up to Week 21

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Aug 2024
  2. Study start31 Jul 2024
  3. Primary completion24 Nov 2025
  4. Study completion24 Nov 2025

Why it stopped: sponsor decision

Resources

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
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
56 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06555601
Sponsor's protocol ID
UP0124
Other IDs
2023-504586-24, U1111-1305-5063, 2023
Status last verified
Sep 2026
First submitted
25 Jul 2024
Last updated
16 Sep 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.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing UCB3101 in people with Healthy Participants, run by UCB Biopharma SRL at 1 site in Belgium.

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 0 inclusion and 31 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: stopped early, as of the sponsor's last update on 16 Sep 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 Belgium. 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 was stopped early (reason given: sponsor decision). Results are not available in the source record.

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 any treatment- emergent adverse events (TEAE) (time frame: From Baseline to Safety Follow-up (up to Week 21)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06555601.

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 16 Sep 2026.

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