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NCT Number: NCT07286682

A 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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Healthy Participants

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Up0161 1001

Harrow, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

UCB5285

Drug

Participants will receive UCB5285 as prespecified in each cohort.

Placebo

Other

Participants will receive matching placebo as prespecified in each cohort.

Primary outcomes

  1. Incidence of Treatment-Emergent Adverse Events (TEAEs)

    Time frame: From Day 1 to the End Of Study (up to Day 161)

    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.

  2. Incidence of Treatment-Emergent Serious Adverse Events (SAEs)

    Time frame: From Day 1 to the End Of Study (up to Day 161)

    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.

Secondary outcomes

  1. Maximum Observed Serum Concentration (Cmax) of UCB5285

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

    Maximum observed serum concentration (Cmax) of UCB5285

  2. Area Under the Serum Concentration-Time Curve From Time Zero to Infinity (AUC) of UCB5285

    Time frame: 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

  3. Area Under the Serum Concentration-Time Curve from Time Zero to the Time of Last Detectable Concentration (AUC0-t) of UCB5285

    Time frame: 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

Sponsors and collaborators

Lead sponsor

UCB Biopharma SRL

Industry

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 16, 2025
Registry last updated
Jul 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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