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The purpose of this randomized, open-label, parallel-group, placebo-controlled study is to assess pain following subcutaneous (SC) administration of gantenerumab as a high-concentration liquid formulation (HCLF) at different injection speeds. The total duration of the study for each healthy participant will be up to approximately 21 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gantenerumab + Placebo | Experimental | Participants will be randomized to receive gantenerumab HCLF and placebo solution via SC injection according to different sequences for the site of administration and different injection speeds. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gantenerumab | Drug | Gantenerumab as a HCLF will be administered via SC injection according to assigned treatment sequence. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Local Pain as Assessed Using Visual Analog Scale (VAS) | Immediately after the injection on Day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Plasma Concentration-Time Curve From Time Zero to Extrapolated Infinite Time (AUC[0-inf]) of Gantenerumab | 0 hour (predose) and 6, 12, and 24 hours postdose on Day 1, on Days 2, 3, 4, 5, 6, 7, 8, 12, 21, 43, 64, 85 | |
| Area Under the VAS Pain-Time Curve From Time 0 to 20 Minutes (AUC[0-20]) |
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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 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31883703 | Derived | Portron A, Jordan P, Draper K, Muenzer C, Dickerson D, van Iersel T, Hofmann C. A Phase I Study to Assess the Effect of Speed of Injection on Pain, Tolerability, and Pharmacokinetics After High-volume Subcutaneous Administration of Gantenerumab in Healthy Volunteers. Clin Ther. 2020 Jan;42(1):108-120.e1. doi: 10.1016/j.clinthera.2019.11.015. Epub 2019 Dec 26. |
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| Placebo | Drug | Gantenerumab Placebo solution will be administered via SC injection according to assigned treatment sequence. |
|
| 0 to 20 minutes after injection on Day 1 |
| Local Pain as Assessed Using Verbal Rating Scale (VRS) Score | Immediately after the injection on Day 1 |
| Number of Participants With Skin Reactivity, as Assessed Using a 0 (No Reactivity) to 3 (Severe Reactivity) Scale | Immediately post-dose to 6 hours on Day 1 |
| Number of Participants With Adverse Events | From Screening to Day 85 |
| Number of Participants With Anti-Gantenerumab Antibodies (ADAs) | Day 1 (predose [Hour 0]) and Day 85 |
| Maximum Observed Plasma Concentration (Cmax) of Gantenerumab | 0 hour (predose) and 6, 12, and 24 hours postdose on Day 1, on Days 2, 3, 4, 5, 6, 7, 8, 12, 21, 43, 64, 85 |
| ID | Term |
|---|---|
| C571128 | gantenerumab |
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