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

UCB

Status and phase: Not yet enrolling; Phase 1

Conditions: Healthy Participants

Treatments: Drug: UCB5285; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT07286682

UP0161

Details and patient eligibility

About

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

Enrollment: 96 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

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96 participants in 8 patient groups

Cohort 1

Experimental group

Description:

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

Treatment:

Other: Placebo

Drug: UCB5285

Cohort 2

Experimental group

Description:

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

Treatment:

Other: Placebo

Drug: UCB5285

Cohort 3

Experimental group

Description:

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

Treatment:

Other: Placebo

Drug: UCB5285

Cohort 4

Experimental group

Description:

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

Treatment:

Other: Placebo

Drug: UCB5285

Cohort 5

Experimental group

Description:

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

Treatment:

Other: Placebo

Drug: UCB5285

Cohort 6

Experimental group

Description:

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

Treatment:

Other: Placebo

Drug: UCB5285

Cohort 7

Experimental group

Description:

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

Treatment:

Other: Placebo

Drug: UCB5285

Cohort 8

Experimental group

Description:

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

Treatment:

Other: Placebo

Drug: UCB5285