A First-in-human Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of UCB3101 in Healthy Participants
- Conditions
- Healthy Participants
- Registration Number
- NCT06555601
- Lead Sponsor
- UCB Biopharma SRL
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 64
Inclusion Criteria:<br><br> - Participant must be capable of giving signed informed consent.<br><br> - Participants are overtly healthy as determined by medical evaluation including<br> medical history, physical examination, laboratory tests, and ECG.<br><br> - Participants with clinical laboratory test results within the reference ranges of<br> the laboratory. Isolated test results that are outside the specified ranges and that<br> are deemed clinically nonsignificant are allowed at the discretion of the<br> investigator (except for liver enzymes). If a participant has 1 isolated test result<br> outside the specific range for which the clinical significance is uncertain, repeat<br> testing may be allowed at the discretion of the investigator.<br><br> - Participants with BP and pulse rate within normal range in the supine position after<br> a 5-minute rest (systolic BP: 90 millimeters of mercury (mmHg) to 140mmHg; diastolic<br> BP: 50mmHg to 90mmHg; pulse rate: 40 Beats Per Minute (bpm) to 100bpm). Any values<br> marginally (ie, no more than 5mmHg) outside the normal range but considered not<br> clinically significant by the investigator will be allowed. For values outside of<br> these permitted ranges, retesting is allowed at the discretion of the investigator.<br><br> - Participants are non-tobacco users or have given up smoking for at least 6 months<br> prior to Screening<br><br> - Participants have received a COVID-19 vaccine, including 2 boosters.<br><br> - Participants with body weight within 50.0 to 110.0 kilogram (kg) and body mass index<br> within the range 18.0 to 30.0 kilogram per meter square (kg/m^2) (inclusive).<br><br> - Participant is male or female.<br><br> 1. Male participants must refrain from donating sperm for the duration of the<br> study and for 3 months after planned completion of the study. A male<br> participant with a female partner who is a woman of childbearing potential<br> (WOCBP) must agree to use contraception for the duration of the study and for 3<br> months after planned completion of the study.<br><br> 2. A female participant is eligible to participate if she is not pregnant, not<br> breastfeeding, and either not a WOCBP or a WOCBP who agrees to follow the<br> contraceptive guidance for the duration of the study and for 1 month after<br> planned completion of the study.<br><br> - Participant must be capable of giving signed informed consent which includes<br> compliance with the requirements and restrictions listed in the ICF.<br><br> - Participant must be considered reliable and capable of adhering to the protocol,<br> according to the judgment of the investigator, and capable of communicating<br> satisfactorily with the investigator and complying with all study requirements.<br><br>Exclusion Criteria:<br><br> - Participant has any medical or psychiatric condition that, in the opinion of the<br> investigator, could jeopardize or would compromise the study participant's ability<br> to participate in this study<br><br> - Participant has any clinically significant ECG abnormalities (as per investigator<br> opinion), including QTc greater than (>)450 millisecond (msec).<br><br> - Participant has a history or presence of psychological or other emotional problems<br> that, in the opinion of the investigator, are likely to invalidate informed<br> permitted to consent or limit the ability of the participant to comply with the<br> protocol requirements.<br><br> - Participant has a lifetime history of suicide attempt (including an actual attempt,<br> interrupted attempt, or aborted attempt), or has suicidal ideation in the past 6<br> months as indicated by positive responses (Yes) to either Question 4 or Question 5<br> of the Columbia-Suicide Severity Rating Scale (C-SSRS) at Screening (only for 30mg<br> onwards SC cohorts and all IV cohorts).<br><br> - Participant has a history of or a current clinically significant psychiatric<br> disorder (eg, bipolar disorder, severe depression, psychosis) requiring or having<br> required hospitalization or medication within the previous 5 years.<br><br> - History or presence of clinically significant (at the discretion of investigators)<br> respiratory, neurological, gastrointestinal, renal, hepatic, pancreatic,<br> hematological, cardiovascular, musculoskeletal, genitourinary, immunological, or<br> dermatological disorders.<br><br> - Participant has had prior history of lymphoma, leukemia, or any malignancy.<br><br> - Participant has a clinically significant active infection (eg, sepsis, pneumonia,<br> abscess) or has had a serious infection (resulting in hospitalization or requiring<br> parenteral antibiotic treatment) within 4 weeks before the first dose of<br> Investigational medicinal product (IMP).<br><br> - Participant has had recurrent (at least 2) clinically relevant infections (example,<br> tooth abscess, opportunistic infections, boils, etc) in the past 6 months.<br><br> - Participant has a history of recurrent headaches, including migraine.<br><br> - Participant has donated or lost >500 milliliter (mL) of blood or blood products<br> within 90 days before Day 1.<br><br> - Participant has evidence or history of significant active bleeding or coagulation<br> disorder.<br><br> - Participant has a history of chronic alcohol or drug abuse within 12 months prior to<br> Baseline.<br><br> - Participant has a known hypersensitivity to any components of the IMP or comparative<br> drugs.<br><br> - Participant has a history of skin disorders or extensive tattooing that prevent<br> clear visibility of the skin in case of a hypersensitivity reaction (especially in<br> the abdominal region, which could prevent correct dosing or evaluation of a local<br> skin reaction).<br><br> - Participant has scheduled surgery between Screening and 1 month after end of study<br> visit.<br><br> - Participant has a known active mycobacterium tuberculosis (TB) disease.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidence of any treatment- emergent adverse events (TEAE)
- Secondary Outcome Measures
Name Time Method Incidence of any treatment-emergent Serious Adverse Events (SAE);Incidence of discontinuation from treatment due to treatment- emergent adverse events (TEAE);Changes from Baseline at each time point in vital signs (blood pressure);Changes from Baseline at each time point in vital signs (pulse rate);Changes from Baseline at each time point in vital signs (body temperature);Number of participants with abnormal laboratory test results (hematology);Number of participants with abnormal laboratory test results (clinical chemistry);Number of participants with abnormal laboratory test results (urinalysis);Number of participants with abnormal 12-lead Electrocardiogram (ECG) assessment;Number of participants with abnormal physical examination findings, including neurological examination findings;Maximum Serum Concentration (Cmax) of UCB3101;Area Under the Concentration-Time Curve (AUC) of UCB3101