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The purpose of this study is to assess the relative bioavailability of the high concentration liquid formulation (HCLF) of gantenerumab produced with the G4 process in comparison to the same HCLF of gantenerumab produced with the G3 process in healthy participants following single SC dose administration.
This multi-center, randomized, open-label, single dose, parallel-group study will assess the relative bioavailability and the safety and tolerability of gantenerumab produced with the G4 process in comparison to gantenerumab produced with the G3 process. All participants will receive single SC dose of gantenerumab (manufactured by either the G3 or G4 process) on Day 1. The total duration of the study for each participant will be up to 21 weeks: Screening (up to 8 weeks); In-clinic period (Days -1 to 3); Out-patient period (Days 4 up to 68); and Safety Follow-up (up to 90 days after dosing).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gantenerumab G4 | Experimental | Participants will receive single dose of gantenerumab HCLF manufactured by G4 process on Day 1. |
|
| Gantenerumab G3 | Experimental | Participants will receive single dose of gantenerumab HCLF manufactured by G3 process on Day 1. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gantenerumab | Drug | Gantenerumab HCLF manufactured by either G3 or G4 process will be administered on Day 1 (in the abdomen). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Plasma Concentration (Cmax) of Gantenerumab | Predose (any time before injection), 1, 6, and 12 hours postdose (after injection) on Day 1; on Days 2, 3, 4, 5, 6, 7, 8, 12, 21, 29, 43, 64, and 85 | |
| Area Under the Plasma Concentration-Time Curve From Time Zero (Predose) to Extrapolated Infinite Time (AUC 0-inf) | Predose (any time before injection), 1, 6, and 12 hours postdose (after injection) on Day 1; on Days 2, 3, 4, 5, 6, 7, 8, 12, 21, 29, 43, 64, and 85 |
| Measure | Description | Time Frame |
|---|---|---|
| Local Pain Assessments Using Visual Analog Scale (VAS) | After needle insertion, immediately postdose, 5 minutes (min), 10 min, 20 min, 1 hour, and 6 hours postdose on Day 1; on Days 2 and 3 | |
| Local Pain Assessments Using Verbal Rating Scale (VRS) | After needle insertion, immediately postdose, 5 min, 10 min, 20 min, 1 hour, and 6 hours postdose on Day 1; on Days 2 and 3 |
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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 |
|---|---|---|---|---|---|---|
| PRA International Clinical Pharmacology Center (EDS US Clinic) | Lenexa | Kansas | 66219 | United States | ||
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| Skin Reactivity Assessment: Percentage of Participants by Severity of Injection Site Reactions | Immediately postdose, 10 min, 1 hour, and 6 hours postdose on Day 1; on Day 3 |
| Skin Reactivity Assessment: Percentage of Participants by Size of Injection Site Reactions | Immediately postdose, 10 min, 1 hour, and 6 hours postdose on Day 1; on Day 3 |
| Percentage of Participants With Adverse Events (AEs) and Serious AEs (SAEs) | AEs: From Day 1 to Day 85; SAEs: From signing informed consent to end of study (maximum up to 5 months) |
| Percentage of Participants With Anti-Gantenerumab Antibodies | Predose (any time before injection) on Day 1 and on Day 85 |
| PRA |
| Marlton |
| New Jersey |
| 08053 |
| United States |
| PRA Health Sciences | Salt Lake City | Utah | 84106 | United States |
| ID | Term |
|---|---|
| C571128 | gantenerumab |
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