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| ID | Type | Description | Link |
|---|---|---|---|
| MK-7240-002 | Other Identifier | MSD |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tulisokibart Dose 1 Treatment Subcutaneous (SC) Injection | Experimental | Participants will receive a single SC injection dose of tulisokibart at dose 1 on Day 1. |
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| Placebo SC Injection | Placebo Comparator | Participants will receive a single SC injection dose of placebo at on Day 1. |
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| Tulisokibart Dose 1 Intravenous (IV) Infusion | Experimental | Participants will receive a single IV infusion dose of tulisokibart at dose 1 on Day 1. |
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| Tulisokibart Dose 2 IV Infusion | Experimental | Participants will receive a single IV infusion dose of tulisokibart at dose 2 on Day 1. |
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| Tulisokibart Dose 3 IV Infusion | Experimental | Participants will receive a single IV infusion dose of tulisokibart at dose 3 on Day 1. |
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| Placebo IV Infusion |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tulisokibart | Drug | SC Injection or IV Infusion |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Experience an Adverse Event (AE) | 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. | Up to 99 Days |
| Number of Participants Who Discontinued the Study Due to AEs | 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. | Up to 99 days |
| Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUC0-last) of Tulisokibart | Blood samples will be collected to determine the AUC0-last of tulisokibart. | Predose and at designated timepoints (up to 99 days postdose) |
| Area Under the Concentration-time Curve From Time Zero to Infinity (AUC0-inf) of Tulisokibart | Blood samples will be collected to determine the AUC0-inf of tulisokibart. | Predose and at designated timepoints (up to 99 days postdose) |
| Maximum Concentration (Cmax) of Tulisokibart | Blood samples will be collected to determine the Cmax of tulisokibart. | Predose and at designated timepoints (up to 99 days postdose) |
| Time to Maximum Concentration (Tmax) of Tulisokibart | Blood samples will be collected to determine the Tmax of tulisokibart. | Predose and at designated timepoints (up to 99 days postdose) |
| Measure | Description | Time Frame |
|---|---|---|
| Absolute Bioavailability Expressed as a Percentage (F%) of SC Tulisokibart | Blood samples will be collected to determine the F% of tulisokibart. | Predose and at designated timepoints (up to 99 days postdose) |
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Inclusion Criteria:
Inclusion Criteria include, but are not limited to:
Exclusion Criteria:
Exclusion Criteria include, but are not limited to:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University Third Hospital (Site 0001) | Beijing | Beijing Municipality | 100191 | China |
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| Label | URL |
|---|---|
| Merck Clinical Trials Information | View source |
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| ID | Term |
|---|---|
| D003093 | Colitis, Ulcerative |
| ID | Term |
|---|---|
| D003092 | Colitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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Participants will receive a single IV infusion dose of placebo on Day 1. |
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| Placebo | Drug | Tulisokibart-matched Placebo SC Injection or IV Infusion |
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| Apparent Terminal Half-life (t1/2) of Tulisokibart | Blood samples will be collected to determine the t1/2 of tulisokibart. | Predose and at designated timepoints (up to 99 days postdose) |
| Apparent Clearance (CL/F) of Tulisokibart | Blood samples will be collected to determine the CL/F of tulisokibart. | Predose and at designated timepoints (up to 99 days postdose) |
| Apparent Volume of Distribution (Vz/F) of Tulisokibart | Blood samples will be collected to determine the Vz/F of tulisokibart. | Predose and at designated timepoints (up to 99 days postdose) |
| D015212 |
| Inflammatory Bowel Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |