Phase 1 SAD and placebo-controlled study to investigate safety, tolerability, & PK of UCB5285 in HV
Research type
Research Study
Full 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
IRAS ID
1012823
Contact name
Parisa Jabbarzadegan
Contact email
Sponsor organisation
UCB Biopharma SRL
Research summary
The trial is a single centre, double blind, randomised trial in up to 96 healthy males and females (of non-childbearing potential), including healthy Japanese participants between ages of 18 to 55. This a first-in-human trial, which means that it’s the first time that this medicine will be given to humans. The study has both placebo and active drug 8 cohorts.
The new medicine tested in this clinical trial is called UCB5285. The purpose of this trial is to see how safe the trial medicine is and how well it’s tolerated after dosing of the clinical trial medicine in healthy subjects. The clinical trial will also investigate how the trial medicine is taken up, metabolised (chemically broken down), distributed through the body and excreted (removed from the body). The trial will also try to understand if the body develops a natural defence against the clinical trial medicine by producing antibodies against the trial medicine.
The total duration of the study for each study participant will be approximately 27 weeks, including up to 28 days of Screening, admission on the day before the trial medication administration (Day -1), trial medicine administration on Day 1, in-clinic monitoring from Day -1 to Day 4, outpatient visits until Day 99, and End of Study Visit on Day 161.REC name
London - Riverside Research Ethics Committee
REC reference
25/LO/0661
Date of REC Opinion
20 Nov 2025
REC opinion
Further Information Favourable Opinion