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This study will evaluate the safety and tolerability profile of BFKB8488A following subcutaneous (SC) administration in overweight and obese participants (body mass index [BMI] greater than [>] 27 to less than or equal to [](streamdown:incomplete-link)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Participants will receive placebo matching to BFKB8488A. |
|
| BFKB8488A SC | Experimental | Participants will receive single ascending SC dose of BFKB8488A in each dose escalation cohort. |
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| BFKB8488A IV | Experimental | Participants will receive single IV dose of BFKB8488A. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BFKB8488A | Drug | Participants will receive either a single escalated dose of BFKB8488A administered SC or a single dose of BFKB8488A administered IV on Day 1. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Adverse Events | From baseline up to 20 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Serum BFKB8488A Concentration | SC Cohort: predose (Hour 0), 4, 24, 72 hours post Day 1 dose, Days 6, 8, 11, 15, 22, 29, 36, 43, 57, 85, 113; IV Cohort: end of infusion on Day 1, 1, 2, 4, 6, 8, 12, 24, 36, 48, 72 hours post Day 1 dose, Days 6, 8, 15, 22, 29, 36, 43 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Profil Institute for Clinical Research Inc. | Chula Vista | California | 91911 | United States |
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| Placebo | Other | Participants will receive a single dose of placebo on Day 1. |
|
| ID | Term |
|---|---|
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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