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

NCT07286682 | Recruiting Phase 1

• 1 other identifier: UP0161
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy Participants

Keywords

UCB5285

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• 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

  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

  From Day 1 (Predose) at predefined time points up to Day 161

Study Arms (8)

Cohort 1

EXPERIMENTAL

Participants randomized to this arm will receive a single dose of UCB5285 (Dose 1) or placebo via Route of Administration 1.

Drug: UCB5285; Other: Placebo

Cohort 2

EXPERIMENTAL

Participants randomized to this arm will receive a single dose of UCB5285 (Dose 2) or placebo via Route of Administration 1.

Drug: UCB5285; Other: Placebo

Cohort 3

EXPERIMENTAL

Participants randomized to this arm will receive a single dose of UCB5285 (Dose 3) or placebo via Route of Administration 1.

Drug: UCB5285; Other: Placebo

Cohort 4

EXPERIMENTAL

Participants randomized to this arm will receive a single dose of UCB5285 (Dose 4) or placebo via Route of Administration 1.

Drug: UCB5285; Other: Placebo

Cohort 5

EXPERIMENTAL

Participants randomized to this arm will receive a single dose of UCB5285 (Dose 4) or placebo Route of Administration 2.

Drug: UCB5285; Other: Placebo

Cohort 6

EXPERIMENTAL

Participants randomized to this arm will receive a single dose of UCB5285 (Dose 5) or placebo via Route of Administration 1.

Drug: UCB5285; Other: Placebo

Cohort 7

EXPERIMENTAL

Participants randomized to this arm will receive a single dose of UCB5285 (Dose 5) or placebo via Route of Administration 2.

Drug: UCB5285; Other: Placebo

Cohort 8

EXPERIMENTAL

Participants randomized to this arm will receive a single dose of UCB5285 (Dose 6) or placebo via Route of Administration 1.

Drug: UCB5285; Other: Placebo

Interventions

UCB5285 DRUG

Participants will receive UCB5285 as prespecified in each cohort.

Cohort 1; Cohort 2; Cohort 3; Cohort 4; Cohort 5; Cohort 6; Cohort 7; Cohort 8

Placebo OTHER

Participants will receive matching placebo as prespecified in each cohort.

Cohort 1; Cohort 2; Cohort 3; Cohort 4; Cohort 5; Cohort 6; Cohort 7; Cohort 8

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• UCB Biopharma SRL: lead

Study Sites (1)

Up0161 1001

Harrow, United Kingdom

RECRUITING

Study Officials

• UCB Cares

  001 844 599 2273 (UCB)

  STUDY DIRECTOR

Central Study Contacts

UCB Cares

CONTACT

+18445992273; ucbcares@ucb.com

UCB Cares

CONTACT

001 844 599 2273

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2025
• First Posted: December 16, 2025
• Study Start: December 8, 2025
• Primary Completion (Estimated): December 13, 2026
• Study Completion (Estimated): December 13, 2026
• Last Updated: December 23, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)