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NCT02133937 · ClinicalTrials.gov registry record · Phase 1

A Study Investigating the Bioavailability of a High Concentration Liquid Formulation Versus a Reference Lyophilized Formulation of Gantenerumab in Healthy Volunteers

A Phase 1 study, sponsored by Hoffmann-La Roche.

Completed
Registry status
Phase 1
Development phase
31
Enrollment target

NCT02133937: Completed Phase 1 study, sponsored by Hoffmann-La Roche.

NCT02133937 is a Phase 1 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 31 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (48% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02133937, a Phase 1 study, has completed, sponsored by Hoffmann-La Roche.

COMPLETED
Registry status
Phase 1
Development phase
31 participants
Enrollment target

Study Summary

This single-center, randomized open-label, single-dose, parallel group study will investigate the relative bioavailability of a high concentration liquid formulation (HCLF) versus the reference lyophilized formulation (LyoF) of gantenerumab. Healthy volunteers will be randomized 1:1 to receive single-dose gantenerumab by subcutaneous injection.

Interventions

  • DRUG gantenerumab

Trial Details

FieldValue
Enrollment Target 31 participants
Start Date 2014-04
Est. Completion 2014-09
Phase Phase 1
Hoffmann-La Roche

909 total trials

What the finished NCT02133937 record still lists

NCT02133937 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 31 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (48% lower).

The record links to 0 conditions, and to 1 intervention - of which gantenerumab is the first listed.

NCT02133937 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02133937 about?

NCT02133937 is a clinical study titled "A Study Investigating the Bioavailability of a High Concentration Liquid Formulation Versus a Reference Lyophilized Formulation of Gantenerumab in Healthy Volunteers". This single-center, randomized open-label, single-dose, parallel group study will investigate the relative bioavailability of a high concentration liquid formulation (HCLF) versus the reference lyophilized formulation (LyoF) of gantenerumab. Healthy volunteers will be randomized 1:1 to receive singl...

What is the current status of trial NCT02133937?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 31 participants. The study started on 2014-04. Estimated completion is 2014-09.

What interventions are being tested in trial NCT02133937?

The interventions under investigation include: gantenerumab (DRUG).

Who is sponsoring clinical trial NCT02133937?

This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02133937's enrollment target sits among peer trials

31 1322nd of 2000 higher than 669 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 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.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT02133937, the US trial registry maintained by the National Library of Medicine. NCT02133937 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.