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| ID | Type | Description | Link |
|---|---|---|---|
| 2025-524693-42-00 | EU Trial (CTIS) Number |
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This study will evaluate safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of single ascending doses (SAD) (Part 1a), multiple ascending doses (MAD) (Part 1b), and the food effect (Part 1c) of RO7763505 in healthy adult participant. In Part 2, the safety, tolerability, PK and PD of multiple doses of RO7763505 in participants with stable coronary artery diseases (CAD).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1: SAD, MAD, and Food Effect in Healthy Participants | Experimental | Healthy participants will receive RO7763505 or matching placebo. |
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| Part 2: In Stable CAD Participants | Experimental | Participants with stable CAD will receive RO7763505 or matching placebo. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RO7763505 | Drug | Participants will receive RO7763505 as per the schedule described in the protocol. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Part 1a and Part 1b: Percentage of Participants With Adverse Events (AEs) | Part 1a: Approximately up to 2 Weeks; Part 1b: Approximately up to 3 Weeks | |
| Part 1c: Plasma Concentration of RO7763505 in Fasted and fed State | Approximately up to 3 Weeks | |
| Part 2: Percentage of Participants With AEs | Approximately up to 6 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Part 1a and Part 1b: Plasma Concentration of RO7763505 and its Metabolites | Part 1a: Approximately up to 2 Weeks; Part 1b: Approximately up to 3 Weeks | |
| Part 1a and Part 1b: Percentage Change From Baseline in Inhibition of Ex Vivo-Stimulated Interleukin-1 Beta ( IL-1β) |
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Inclusion Criteria:
Part 1:
Part 2:
Exclusion Criteria:
Part 1:
Part 2:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Reference Study ID Number: BP46355 https://forpatients.roche.com/ | Contact | 888-662-6728 (U.S. and Canada) | global-roche-genentech-trials@gene.com | |
| Fastest response: use the inquiry form. No email attachments. https://www.gene.com/contact-us/submit-medical-inquiry | Contact |
| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ICON Plc (LPRA) - Netherlands | Recruiting | Groningen | 9728 NZ | Netherlands |
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| Label | URL |
|---|---|
| Please use this form to submit your questions for a faster response: https://www.gene.com/contact-us/submit-medical-inquiry. Do not include or attach any medical records when emailing or completing the form. A nurse will respond within 24 business hours. | View source |
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Parts 1a, 1b, and 2: Double blind
Part 1c: Open-label
| Placebo | Drug | Participants will receive matching placebo as per the schedule described in the protocol. |
|
| Part 1a: Baseline, Approximately up to 2 Weeks; Part 1b: Baseline, Approximately up to 3 Weeks |
| Part 1c: Percentage of Participants With AEs | Approximately up to 3 Weeks |
| Part 2: Plasma Concentration of RO7763505 and its Metabolites | Approximately up to 6 Weeks |
| Part 2: Percentage Change From Baseline in Inhibition of Ex Vivo-Stimulated IL-1β | Baseline, Approximately up to 6 Weeks |