A Study of A High Concentration Liquid Formulation Versus A Lyophilized Formulation of Gantenerumab in Healthy Volunteers

A Multi-center, Randomized Open-label, Single-dose, Parallel Group Investigation of the Relative Bioavailability, Tolerability and Dose-exposure Relationship of a High Concentration Liquid Formulation (HCLF) Versus a Lyophilized Formulation (LyoF) of RO4909832 (Gantenerumab) When Administered by su

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01636531

Enrollment

120

Registered

2012-07-10

Start date

2012-05-31

Completion date

2012-10-31

Last updated

2016-11-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteer

Brief summary

This multi-center, randomized, open-label, single-dose, parallel group study will assess the relative bioavailability, tolerability and dose-exposure relationship of a high concentration liquid formulation (HCLF) versus a lyophilized formulation (LyoF) of gantenerumab (RO4909832) in healthy volunteers. Subjects will be randomized to receive single subcutaneous doses of either HCLF or LyoF. Anticipated time for treatment period and follow-up will be 13 weeks.

Interventions

DRUGgantenerumab

High concentration liquid formulation (HCLF), single dose sc

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

40 Years to 70 Years

Healthy volunteers

Yes

Inclusion criteria

* Healthy male and female subjects, 40 to 70 years of age. Healthy status is defined by absence of evidence of any active or chronic disease following a detailed medical and surgical history and a complete physical examination * Body mass index 18.0 to 30.0 kg/m2 inclusive * Female subjects who are either surgically sterilized or post-menopausal * Agree not to donate blood or blood products for transfusion for the duration of the study and for one year after their dosing

Exclusion criteria

* Suspicion of alcohol or drugs of abuse addiction * Positive for hepatitis B, hepatitis C or HIV 1 or 2 infection * Participation in an investigational drug or device study within three months before dosing * Concomitant disease or condition or treatment which could interfere with the conduct of the study or that would, in the opinion of the investigator, pose an unacceptable risk to the subject in this study * Any clinically relevant history of hypersensitivity or allergic reactions, either spontaneous or following drug administration or exposure to food or environmental agents * Any familial history of early onset Alzheimer's disease * Claustrophobia, presence of pacemakers, aneurism clips, artificial heart valves, ear implants, or foreign metal objects in the eyes, skin or body which would contraindicate an MRI scan

Design outcomes

Primary

Measure	Time frame
Relative bioavailability: Area under the concentration-time curve	Pre-dose and up to 85 days post-dose

Secondary

Measure	Time frame
Safety: Incidence of adverse events	approximately 8 months
Dose-exposure relationship	approximately 8 months

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026