Healthy Participants
Conditions
Keywords
UCB5285
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
Interventions
DRUGUCB5285
Participants will receive UCB5285 as prespecified in each cohort.
OTHERPlacebo
Participants will receive matching placebo as prespecified in each cohort.
Sponsors
UCB Biopharma SRL
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Treatment-Emergent Adverse Events (TEAEs) | 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. |
| Incidence of Treatment-Emergent Serious Adverse Events (SAEs) | 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
| Measure | Time frame | Description |
|---|---|---|
| Maximum Observed Serum Concentration (Cmax) of UCB5285 | From Day 1 (Predose) at predefined time points up to Day 161 | Maximum observed serum concentration (Cmax) 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 infinity (AUC) 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 | Area under the serum concentration-time curve from time zero to the time of last detectable concentration (AUC0-t) of UCB5285 |
Countries
United Kingdom
Contacts
STUDY_DIRECTORUCB Cares
001 844 599 2273 (UCB)
Outcome results
None listed