A Study Investigating the Bioavailability of a High Concentration Liquid Formulation Versus a Reference Lyophilized Formulation of Gantenerumab in Healthy Volunteers
Status: | Completed |
---|---|
Conditions: | Healthy Studies |
Therapuetic Areas: | Other |
Healthy: | No |
Age Range: | 40 - 70 |
Updated: | 8/3/2016 |
Start Date: | April 2014 |
End Date: | September 2014 |
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
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.
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.
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
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