Single-dose safety and pharmacokinetics of UCB5285 in healthy adults

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

This study will test single ascending doses of UCB5285 versus placebo in healthy adults to see if the drug is safe, well tolerated, and how it behaves in the body, including a group of Japanese participants.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 96 (estimated)
• Ages: 18 Years to 55 Years
• Sex: All
• Sponsor: UCB Pharma (Industry-sponsored)
• Locations: 1 site (Harrow)
• Trial ID: NCT07286682 on ClinicalTrials.gov

What this trial studies

This Phase 1, single ascending dose study gives healthy adult volunteers one dose of UCB5285 or placebo and closely monitors them for safety, tolerability, and pharmacokinetics. Participants are healthy men and women aged 18–55 meeting weight and BMI criteria, with a defined cohort of participants of Japanese descent. Clinical assessments include physical exams, laboratory tests, ECGs, and cardiac and vital-sign monitoring after dosing. The goal is to identify safety signals, tolerable dose ranges, and how the drug is absorbed, distributed, metabolized, and eliminated.

Who should consider this trial

Good fit: Healthy adults 18–55 years old with body weight 40–110 kg and BMI 18–30 kg/m2, including people of Japanese descent who meet the study's ancestry and lifestyle criteria, are ideal candidates.

Not a fit: People with any active medical or psychiatric condition, abnormal labs/ECG/vital signs, or who fall outside the age, weight, or BMI limits are unlikely to be eligible or to benefit from participation.

Why it matters

Potential benefit: If successful, this could identify a safe dose and pharmacokinetic profile to support further testing of UCB5285 in patient populations.

How similar studies have performed: Single ascending dose safety and PK studies are a standard first-in-human approach, and UCB5285 appears to be a novel compound with human effects not yet established.

Eligibility 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 this trial is running

Harrow

• Up0161 1001 — Harrow, United Kingdom (Recruiting)

Study contacts

• Study coordinator: UCB Cares

Conditions Healthy Participants; UCB5285