NCT03236844

Relative Bioavailability of Gantenerumab Produced by G4 Process Versus G3 Process Following Subcutaneous (SC) Injection in Healthy Participants

A Multi-Center, Randomized, Open-Label, Single-Dose, Parallel Group Study to Investigate the Relative Bioavailability of Gantenerumab Produced With the G4 Process in Comparison to Gantenerumab Produced With the G3 Process Following Administration by Subcutaneous Injection in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 114 (actual)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to assess the relative bioavailability of the high concentration liquid formulation (HCLF) of gantenerumab produced with the G4 process in comparison to the same HCLF of gantenerumab produced with the G3 process in healthy participants following single SC dose administration.

Detailed description

This multi-center, randomized, open-label, single dose, parallel-group study will assess the relative bioavailability and the safety and tolerability of gantenerumab produced with the G4 process in comparison to gantenerumab produced with the G3 process. All participants will receive single SC dose of gantenerumab (manufactured by either the G3 or G4 process) on Day 1. The total duration of the study for each participant will be up to 21 weeks: Screening (up to 8 weeks); In-clinic period (Days -1 to 3); Out-patient period (Days 4 up to 68); and Safety Follow-up (up to 90 days after dosing).

Conditions

• Healthy Participants

Interventions

Type	Name	Description
DRUG	Gantenerumab	Gantenerumab HCLF manufactured by either G3 or G4 process will be administered on Day 1 (in the abdomen).

Timeline

• Start date: 2017-08-01
• Primary completion: 2017-12-15
• Completion: 2017-12-15
• First posted: 2017-08-02
• Last updated: 2018-12-12

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study