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

Completed · Phase 1

Conditions studied: Healthy Participants

In brief

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.

Key facts

Study ID

NCT03236844

Run by

Hoffmann-La Roche

People needed

114

Starts

2017-08-01

Expected to finish

2017-12-15

Last updated by the study team

2018-12-12

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Healthy participant
• Body mass index (BMI) between 18.0 and 30.0 kilograms per meter-square (kg/m\^2), inclusive
• Body weight between 55 to 110 kg inclusive
• Female participants with either non-childbearing potential or with childbearing potential who commit to remain abstinent or use acceptable contraceptive methods during the treatment period and until at least 6 months after the follow-up visit
• Women of childbearing potential must have a negative serum pregnancy test result at screening and Day 1

You may not qualify if…

• History of any clinically significant gastrointestinal, renal, hepatic, broncho-pulmonary, neurological, psychiatric, cardio-vascular, endocrinological, hematological or allergic disease, metabolic disorder, cancer, or cirrhosis
• History or suspicion of drugs of abuse addiction
• History or suspicion of alcohol addiction
• Pregnant or breastfeeding, or intending to become pregnant during the study or within 17 weeks after the last dose of study drug
• Prior administration of gantenerumab
• Clinically significant abnormalities (as judged by the investigator) in laboratory test results (including complete blood count, chemistry panel, and urinalysis)
• Concomitant disease or condition that could interfere with, or treatment of which might interfere with, the conduct of the study, or that would, in the opinion of the investigator, pose an unacceptable risk to the participant in this study

Where it is running

• PRA International Clinical Pharmacology Center (EDS US Clinic) — Lenexa, Kansas, United States
• PRA — Marlton, New Jersey, United States
• PRA Health Sciences — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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