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

Study Overview
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Brief Summary
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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.

Official Title
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A Single-center, Randomized Open-label, Single-dose, Parallel Group Study to Investigate the Relative Bioavailability of a High Concentration Liquid Formulation (Hclf) in Prefilled Syringes Versus the Reference Lyophilized Formulation (Lyof) of Gantenerumab Following Administration by Subcutaneous Injection in Healthy Volunteers

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 inclusive. Healthy status is defined by absence of evidence any active or chronic disease following a detailed medical and surgical history, a complete physical examination including vital signs, 12-lead ECG, hematology, blood chemistry, coagulation, serology and urinalysis. Some medical conditions are allowed that are well controlled by single stable medication A BMI between 18.0 to 30.0 kg/m2 inclusive Use of highly effective contraception until 6 months after study follow-up visit 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 abuse addiction using DSM IV criteria Regular smoker (> 5 cigarettes, > 1 pipeful or > 1 cigar per day), tobacco users and subjects on nicotine replacement therapy Prior administration of gantenerumab Participation in an investigational drug or device study within 60 days before dosing Donation of blood over 500 mL within three months before dosing Pregnancy or breast-feeding Any abnormal skin conditions or potentially obscuring tattoos, pigmentation or lesions in the area intended for subcutaneous injection Any familial history of early onset Alzheimer's disease Claustrophobia, presence of pacemakers, aneurysm 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

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: High Concentration Liquid Formulation (HCLF)<br> | Drug: gantenerumab<br>* Single subcutaneous injection of a high concentration liquid formulation<br>|
| Active Comparator: Lyophilized formulation<br> | Drug: gantenerumab<br>* Single subcutaneous injection of a lyophilized formulation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma concentration of gantenerumab |  | Up to 13 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of adverse events |  | Approximately 21 weeks |