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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02133937

Enrollment

Registered

2014-05-08

Start date

2014-04-30

Completion date

2014-09-30

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 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.

Interventions

DRUGgantenerumab

Single subcutaneous injection of a high concentration liquid formulation

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

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 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

Design outcomes

Primary

Measure	Time frame
Plasma concentration of gantenerumab	Up to 13 weeks

Secondary

Measure	Time frame
Incidence of adverse events	Approximately 21 weeks

Countries

United States

Outcome results

None listed

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