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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 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.

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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

FieldValue
Enrollment Target 48 participants
Start Date 2016-08-31
Est. Completion 2017-03-22
Phase Phase 1

Sponsor

Hoffmann-La Roche

909 total trials

What the Registry Record Tells You About NCT02882009

The ClinicalTrials.gov registry entry for NCT02882009 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 48 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 201-participant average among 112 other Healthy Volunteer trials with a reported enrollment target (76% lower). The listed sponsor is Hoffmann-La Roche, which has 909 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.