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

NCT ID: NCT07286682

Last Updated: 2025-12-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

96 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-08

Study Completion Date

2026-12-13

Brief Summary

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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

Detailed Description

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Conditions

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Healthy Participants

Keywords

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UCB5285

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Cohort 6

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

Group Type EXPERIMENTAL

UCB5285

Intervention Type DRUG

Participants will receive UCB5285 as prespecified in each cohort.

Placebo

Intervention Type OTHER

Participants will receive matching placebo as prespecified in each cohort.

Cohort 7

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

Group Type EXPERIMENTAL

UCB5285

Intervention Type DRUG

Participants will receive UCB5285 as prespecified in each cohort.

Placebo

Intervention Type OTHER

Participants will receive matching placebo as prespecified in each cohort.

Cohort 8

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

Group Type EXPERIMENTAL

UCB5285

Intervention Type DRUG

Participants will receive UCB5285 as prespecified in each cohort.

Placebo

Intervention Type OTHER

Participants will receive matching placebo as prespecified in each cohort.

Cohort 1

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

Group Type EXPERIMENTAL

UCB5285

Intervention Type DRUG

Participants will receive UCB5285 as prespecified in each cohort.

Placebo

Intervention Type OTHER

Participants will receive matching placebo as prespecified in each cohort.

Cohort 2

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

Group Type EXPERIMENTAL

UCB5285

Intervention Type DRUG

Participants will receive UCB5285 as prespecified in each cohort.

Placebo

Intervention Type OTHER

Participants will receive matching placebo as prespecified in each cohort.

Cohort 3

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

Group Type EXPERIMENTAL

UCB5285

Intervention Type DRUG

Participants will receive UCB5285 as prespecified in each cohort.

Placebo

Intervention Type OTHER

Participants will receive matching placebo as prespecified in each cohort.

Cohort 4

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

Group Type EXPERIMENTAL

UCB5285

Intervention Type DRUG

Participants will receive UCB5285 as prespecified in each cohort.

Placebo

Intervention Type OTHER

Participants will receive matching placebo as prespecified in each cohort.

Cohort 5

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

Group Type EXPERIMENTAL

UCB5285

Intervention Type DRUG

Participants will receive UCB5285 as prespecified in each cohort.

Placebo

Intervention Type OTHER

Participants will receive matching placebo as prespecified in each cohort.

Interventions

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UCB5285

Participants will receive UCB5285 as prespecified in each cohort.

Intervention Type DRUG

Placebo

Participants will receive matching placebo as prespecified in each cohort.

Intervention Type OTHER

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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UCB Biopharma SRL

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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UCB Cares

Role: STUDY_DIRECTOR

001 844 599 2273 (UCB)

Locations

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Up0161 1001

Harrow, , United Kingdom

Site Status RECRUITING

Countries

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United Kingdom

Central Contacts

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UCB Cares

Role: CONTACT

Phone: +18445992273

Email: [email protected]

UCB Cares

Role: CONTACT

Phone: 001 844 599 2273

Other Identifiers

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UP0161

Identifier Type: -

Identifier Source: org_study_id