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

Roche

Status and phase

Completed

Phase 1

Conditions

Healthy Volunteer

Treatments

Drug: gantenerumab

Study type

Interventional

Funder types

Industry

Identifiers

NCT01636531

WP27951

2011-006093-65 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment

120 patients

Sex

All

Ages

40 to 70 years old

Volunteers

Accepts Healthy Volunteers

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