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ACTIVE NOT RECRUITINGPhase1

A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of UCB5285 in Healthy Study Participants

Sponsor: UCB Biopharma SRL

NCT ID: NCT07286682

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
UCB5285 (drug), Placebo (other)
How long the study runs
Study runs about 12 months (dates as stated)
About the drug or intervention
UCB5285 — drug: Participants will receive UCB5285 as prespecified in each cohort. · Placebo — other: Participants will receive matching placebo as prespecified in each cohort.
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
18 Years to 55 Years
Who
All
Number of participants
80
Started
2025-12-08
Last checked
2026-07

Plain English Summary

What is this study?

  • • Testing a new treatment for healthy participants
  • • Phase1 - 80 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

Who can take part?

  • • Ages 18 Years to 55 Years
  • • Diagnosed with healthy participants

Where?

  • • Harrow - Up0161 1001

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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

Healthy Participants

How this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

Still need:

  • • Tell us your age for better matching
  • • Tell us your sex for better matching

Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years - 55 Years
  • Who can join: All genders

What the study is looking for

  • ✓For all study participants:
  • ✓Study participant must be 18 to 55 years of age, inclusive, at the time of signing the agreement to take part
  • ✓Study participants who are overtly healthy as determined by medical evaluation including medical history, physical...
  • ✓Body weight within 40 kilograms (kg) to 110 kg and body mass index (BMI) within the range of 18 kilograms per meter...

Who cannot take part

  • ✗Study participant has a recent history (within 6 months of Screening) or currently active clinically significant...
  • ✗Study participant has a significant allergy to humanized monoclonal antibody (mAbs)
See the full criteria
Inclusion Criteria: * 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) Exclusion Criteria: * 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)

Where Is This Study? (1 UK site)

Up0161 1001

Harrow, United Kingdom

Data sourced from ClinicalTrials.gov · Last verified: 2026-07