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This study will estimate the absolute bioavailability of subcutaneously injected GS-5745, characterize the safety, tolerability, and pharmacokinetics (PK) of GS-5745 after subcutaneous (SC) injection and intravenous (IV) administration, and evaluate the formation of anti-GS-5745 antibodies after SC and IV administration.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GS-5745 SC | Experimental | Participants will receive a single dose of GS-5745 by SC injection. |
|
| GS-5745 IV | Experimental | Participants will receive a single dose of GS-5745 by IV infusion. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GS-5745 SC | Drug | GS-5745 150 mg administered by SC injection formulated as a sterile, aqueous buffered solution in a single-use pre-filled syringe |
|
| Measure | Description | Time Frame |
|---|---|---|
| PK profile of GS-5745 | This composite endpoint will measure the plasma PK profile of GS-5745. The following parameters will be measured, where applicable:
| Predose and postdose on Days 1 and Day 11, and Weeks 2, 3, 4, 6, and 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Incidences of adverse events and laboratory abnormalities | This composite endpoint will measure the safety and tolerability profile of GS-5745. | Up to 8 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bittoo Kanwar, MD | Gilead Sciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Christchurch | New Zealand |
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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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| GS-5745 IV | Drug | GS-5745 150 mg administered by IV infusion formulated as a sterile, aqueous buffered solution in single-use glass vials |
|
| D015212 |
| Inflammatory Bowel Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |