Colitis, Ulcerative
Conditions
Brief summary
The goal of this study is to learn about the safety of tulisokibart in healthy participants and what happens to tulisokibart over time when participants receive treatment intravenously versus subcutaneously.
Interventions
DRUGTulisokibart
SC Injection or IV Infusion
DRUGPlacebo
Tulisokibart-matched Placebo SC Injection or IV Infusion
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
Inclusion Criteria include, but are not limited to: * Be in good health * Has a body mass index (BMI) ≥18 and ≤28 kg/m\^2 and weight ≥40.0 kg * Continuous non-smoker who has not used tobacco or nicotine-containing products for at least 3 months prior to the dosing of study drug
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Apparent Volume of Distribution (Vz/F) of Tulisokibart | Predose and at designated timepoints (up to 99 days postdose) | Blood samples will be collected to determine the Vz/F of tulisokibart. |
| Time to Maximum Concentration (Tmax) of Tulisokibart | Predose and at designated timepoints (up to 99 days postdose) | Blood samples will be collected to determine the Tmax of tulisokibart. |
| Apparent Terminal Half-life (t1/2) of Tulisokibart | Predose and at designated timepoints (up to 99 days postdose) | Blood samples will be collected to determine the t1/2 of tulisokibart. |
| Apparent Clearance (CL/F) of Tulisokibart | Predose and at designated timepoints (up to 99 days postdose) | Blood samples will be collected to determine the CL/F of tulisokibart. |
| Number of Participants Who Experience an Adverse Event (AE) | Up to 99 Days | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of the study intervention, whether or not considered related to the study intervention. |
| Number of Participants Who Discontinued the Study Due to AEs | Up to 99 days | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of the study intervention, whether or not considered related to the study intervention. |
| Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUC0-last) of Tulisokibart | Predose and at designated timepoints (up to 99 days postdose) | Blood samples will be collected to determine the AUC0-last of tulisokibart. |
| Area Under the Concentration-time Curve From Time Zero to Infinity (AUC0-inf) of Tulisokibart | Predose and at designated timepoints (up to 99 days postdose) | Blood samples will be collected to determine the AUC0-inf of tulisokibart. |
| Maximum Concentration (Cmax) of Tulisokibart | Predose and at designated timepoints (up to 99 days postdose) | Blood samples will be collected to determine the Cmax of tulisokibart. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Absolute Bioavailability Expressed as a Percentage (F%) of SC Tulisokibart | Predose and at designated timepoints (up to 99 days postdose) | Blood samples will be collected to determine the F% of tulisokibart. |
Countries
China
Outcome results
None listed