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| ID | Type | Description | Link |
|---|---|---|---|
| WP40225 | Other Identifier | Hoffman LaRoche Protocol ID |
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Randomized study in healthy men and women. Assess the similarity of RO7239361 when injected into the arm, thigh, or the stomach. Collect data on safety of RO7239361.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment A: RO7239361 | Active Comparator | RO7239361 subcutaneous injections on specified days; abdomen |
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| Treatment B: RO7239361 | Active Comparator | RO7239361 subcutaneous injections on specified days; arm |
|
| Treatment C: RO7239361 | Active Comparator | RO7239361 subcutaneous injections on specified days; thigh |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RO7239361 | Drug | Specified dose on specified days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum observed serum concentration (Cmax) | Up to 92 days | |
| AUC from time zero to time of last quantifiable concentration [AUC(0-T)] | Up to 92 days | |
| AUC from time zero extrapolated to infinite time [AUC(INF)] | Up to 92 days |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Adverse Events ( AEs) | Up to 92 days | |
| Incidence of Serious Adverse Events (SAEs) | Up to 92 days | |
| Change from baseline in electrocardiogram findings |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol defined inclusion and exclusion criteria apply
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| WCCT Global, Inc. | Cypress | California | 90630 | United States |
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| Label | URL |
|---|---|
| FDA Safety Alerts and Recalls | View source |
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| Up to 92 days |
| Change from baseline in physical examination findings | Up to 92 days |
| Change from baseline in clinical laboratory test findings | Up to 92 days |