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The main purpose of this study is to evaluate the safety and tolerability of single and multiple ascending doses of RO7806881 in healthy participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RO7806881: Single Ascending Dose (SAD) | Experimental | Participants will receive single doses of RO7806881, at 8 dose levels across different cohorts. |
|
| Placebo: SAD | Placebo Comparator | Participants will receive single doses of placebo, matched to each of the 8 dose levels of RO7806881. |
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| RO7806881: Multiple Ascending Doses (MAD) | Experimental | Participants will receive multiple doses of RO7806881, at 4 dose levels across different cohorts, per the predefined dosing regimen. |
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| Placebo: MAD | Placebo Comparator | Participants will receive multiple doses of placebo, matched to each of the 4 dose levels of RO7806881, per the predefined dosing regimen. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RO7806881 | Drug | RO7806881 will be administered as per the schedule specified in the protocol. |
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| Measure | Description | Time Frame |
|---|---|---|
| SAD Part: Number of Participants With Adverse Events (AEs) | Up to Day 127 | |
| MAD Part: Number of Participants With AEs | Up to Day 162 | |
| SAD Part: Number of Participants With Dose-limiting Adverse Events (DLAEs) | Up to Day 127 | |
| MAD Part: Number of Participants With DLAEs | Up to Day 162 |
| Measure | Description | Time Frame |
|---|---|---|
| SAD and MAD Parts: Serum Concentration of RO7806881 | SAD: Up to Day 127; MAD: Up to Day 162 | |
| SAD and MAD Parts: Maximum Concentration (Cmax) of RO7806881 | SAD: Up to Day 127; MAD: Up to Day 162 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Reference Study ID Number: BP46089 https://forpatients.roche.com/ | Contact | 888-662-6728 | 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 |
|---|---|---|---|---|---|---|
| New Zealand Clinical Research - Christchurch | Recruiting | Christchurch | 8011 | New Zealand |
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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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| Placebo | Drug | Placebo will be administered as per the schedule specified in the protocol. |
|
| SAD and MAD Parts: Minimum Concentration (Cmin) of RO7806881 |
| SAD: Up to Day 127; MAD: Up to Day 162 |
| SAD and MAD Parts: Area Under the Curve (AUC) From the Last Time of Dosing to the Last Measurable Concentration (AUClast) of RO7806881 | SAD: Up to Day 127; MAD: Up to Day 162 |
| SAD and MAD Parts: Apparent Total Body Clearance (CL/F) of RO7806881 | SAD: Up to Day 127; MAD: Up to Day 162 |
| SAD and MAD Parts: Volume of Distribution at Steady-state Conditions (Vss) of RO7806881 | SAD: Up to Day 127; MAD: Up to Day 162 |
| SAD and MAD Parts: Dose Proportionality for AUC | SAD: Up to Day 127; MAD: Up to Day 162 |
| SAD and MAD Parts: Dose Proportionality for Cmax | SAD: Up to Day 127; MAD: Up to Day 162 |
| MAD Part: Accumulation Ratio (Racc) of RO7806881 | Up to Day 162 |
| SAD and MAD Parts: Absolute Bioavailability of RO7806881 | SAD: Up to Day 127; MAD: Up to Day 162 |