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NCT02882009 · ClinicalTrials.gov registry record · Phase 1
A Study to Assess the Impact of Speed and Site of Subcutaneous Injection on Pain, Tolerability, Safety, and Pharmacokinetics of Gantenerumab in Healthy Participants
A Phase 1 study of Healthy Volunteer, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 1
- Development phase
- 48
- Enrollment target
- 1
- Study location
NCT02882009: Completed Phase 1 study of Healthy Volunteer, sponsored by Hoffmann-La Roche.
NCT02882009 is a Phase 1 study of Healthy Volunteer that has completed, run by Hoffmann-La Roche. The registered enrollment target is 48 participants, below the 201-participant average among 112 other Healthy Volunteer trials with a reported enrollment target (76% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02882009, a Phase 1 study of Healthy Volunteer, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 48 participants
- Enrollment target
- 1
- Study location
Study Summary
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.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Gantenerumab
Study Locations (1)
Kansas
- PRA International Clinical Pharmacology Center (EDS US Clinic) - Lenexa
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 48 participants |
| Start Date | 2016-08-31 |
| Est. Completion | 2017-03-22 |
| Phase | Phase 1 |
What the finished NCT02882009 record still lists
NCT02882009 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 48 participants, a relatively small participant target, below the 201-participant average among 112 other Healthy Volunteer trials with a reported enrollment target (76% lower).
The record links to 1 condition, with Healthy Volunteer appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT02882009 reports a single indexed study location in Kansas.
Frequently Asked Questions
What is clinical trial NCT02882009 about?
NCT02882009 is a clinical study titled "A Study to Assess the Impact of Speed and Site of Subcutaneous Injection on Pain, Tolerability, Safety, and Pharmacokinetics of Gantenerumab in Healthy Participants". 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 particip...
What is the current status of trial NCT02882009?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 48 participants. The study started on 2016-08-31. Estimated completion is 2017-03-22.
What conditions does trial NCT02882009 study?
This clinical trial studies the following conditions: Healthy Volunteer.
What interventions are being tested in trial NCT02882009?
The interventions under investigation include: Placebo (DRUG), Gantenerumab (DRUG).
Who is sponsoring clinical trial NCT02882009?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02882009 being conducted?
This trial has 1 study location across Kansas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Healthy Volunteer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02882009's enrollment target sits among peer trials
48 59th of 112 higher than 52 of 112 other Healthy Volunteer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Healthy Volunteer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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