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

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

Study Overview

• Status: Recruiting
• Conditions: Healthy Participants
• Intervention / Treatment: Drug: UCB5285; Other: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 96
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: UCB Cares; Phone Number: 001 844 599 2273
• Study Contact Backup: Name: UCB Cares; Phone Number: +18445992273; Email: ucbcares@ucb.com

Study Locations

• United Kingdom
  • Harrow, United Kingdom
    • Recruiting
    • Up0161 1001

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Double

Number of Arms

8

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cohort 1; Participants randomized to this arm will receive a single dose of UCB5285 (Dose 1) or placebo via Route of Administration 1.	Drug: UCB5285; Participants will receive UCB5285 as prespecified in each cohort.; Other: Placebo; Participants will receive matching placebo as prespecified in each cohort.
Experimental: Cohort 2; Participants randomized to this arm will receive a single dose of UCB5285 (Dose 2) or placebo via Route of Administration 1.	Drug: UCB5285; Participants will receive UCB5285 as prespecified in each cohort.; Other: Placebo; Participants will receive matching placebo as prespecified in each cohort.
Experimental: Cohort 3; Participants randomized to this arm will receive a single dose of UCB5285 (Dose 3) or placebo via Route of Administration 1.	Drug: UCB5285; Participants will receive UCB5285 as prespecified in each cohort.; Other: Placebo; Participants will receive matching placebo as prespecified in each cohort.
Experimental: Cohort 4; Participants randomized to this arm will receive a single dose of UCB5285 (Dose 4) or placebo via Route of Administration 1.	Drug: UCB5285; Participants will receive UCB5285 as prespecified in each cohort.; Other: Placebo; Participants will receive matching placebo as prespecified in each cohort.
Experimental: Cohort 5; Participants randomized to this arm will receive a single dose of UCB5285 (Dose 4) or placebo Route of Administration 2.	Drug: UCB5285; Participants will receive UCB5285 as prespecified in each cohort.; Other: Placebo; Participants will receive matching placebo as prespecified in each cohort.
Experimental: Cohort 6; Participants randomized to this arm will receive a single dose of UCB5285 (Dose 5) or placebo via Route of Administration 1.	Drug: UCB5285; Participants will receive UCB5285 as prespecified in each cohort.; Other: Placebo; Participants will receive matching placebo as prespecified in each cohort.
Experimental: Cohort 7; Participants randomized to this arm will receive a single dose of UCB5285 (Dose 5) or placebo via Route of Administration 2.	Drug: UCB5285; Participants will receive UCB5285 as prespecified in each cohort.; Other: Placebo; Participants will receive matching placebo as prespecified in each cohort.
Experimental: Cohort 8; Participants randomized to this arm will receive a single dose of UCB5285 (Dose 6) or placebo via Route of Administration 1.	Drug: UCB5285; Participants will receive UCB5285 as prespecified in each cohort.; Other: Placebo; Participants will receive matching placebo as prespecified in each cohort.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	From Day 1 to the End Of Study (up to Day 161)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum Observed Serum Concentration (Cmax) of UCB5285	Maximum observed serum concentration (Cmax) of UCB5285	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	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	From Day 1 (Predose) at predefined time points up to Day 161

Collaborators and Investigators

• Sponsor: UCB Biopharma SRL
• Investigators: Study Director: UCB Cares, 001 844 599 2273 (UCB)

Study record dates

Study Major Dates

• Study Start (Actual): December 8, 2025
• Primary Completion (Estimated): December 13, 2026
• Study Completion (Estimated): December 13, 2026

Study Registration Dates

• First Submitted: December 3, 2025
• First Submitted That Met QC Criteria: December 3, 2025
• First Posted (Estimated): December 16, 2025

Study Record Updates

• Last Update Posted (Actual): December 23, 2025
• Last Update Submitted That Met QC Criteria: December 16, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: UCB5285
• Other Study ID Numbers: UP0161

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No