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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Healthy Volunteer

Intervention / Treatment
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* Drug: gantenerumab
* Drug: gantenerumab


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HCLF<br> | Drug: gantenerumab<br>* High concentration liquid formulation (HCLF), single dose sc<br>|
| Active Comparator: LyoF<br> | Drug: gantenerumab<br>* Lyophilized formulation (LyoF), single dose sc<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety: Incidence of adverse events |  | approximately 8 months | 
| Dose-exposure relationship |  | approximately 8 months |