A Study to Assess the Impact of Speed and Site of Subcutaneous Injection on Pain, Tolerability, Safety, and Pharmacokinetics of Gantenerumab in Healthy Participants

Completed · Phase 1 · Has a placebo group

Conditions studied: Healthy Volunteer

In brief

The purpose of this randomized, open-label, parallel-group, placebo-controlled study is to assess pain following subcutaneous (SC) administration of gantenerumab as a high-concentration liquid formulation (HCLF) at different injection speeds. The total duration of the study for each healthy participant will be up to approximately 21 weeks.

Key facts

Study ID

NCT02882009

Run by

Hoffmann-La Roche

People needed

48

Starts

2016-08-31

Expected to finish

2017-03-22

Last updated by the study team

2019-06-11

Who can join

Age: 40 and older, up to 80. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Healthy male and female participants (healthy status is defined by the absence of evidence of any active or chronic disease following a detailed medical and surgical history, a complete physical examination including vital signs, 12-lead electrocardiogram, hematology, blood chemistry, coagulation, serology, and urinalysis)
• Body mass index between 18.0 and 30.0 kilograms per meter squared (kg/m\^2), inclusive
• Female participants of childbearing potential must commit to use two acceptable forms of contraception during the study and until at least 6 months after the follow-up visit

You may not qualify if…

• History of any clinically significant gastrointestinal, renal, hepatic, broncho-pulmonary, neurological, psychiatric, cardiovascular, endocrinological, hematological or allergic disease, metabolic disorder, cancer, or cirrhosis
• History or suspicion of drugs of abuse or alcohol addiction
• Smokers who smoke more than 10 cigarettes per day or equivalent amount of tobacco as determined by history
• Pregnant or lactating women
• Positive result on hepatitis B virus (HBV), hepatitis C virus (HCV), or Human immunodeficiency virus (HIV)-1 and -2
• Any familial history of early onset Alzheimer's disease
• Prior administration of gantenerumab
• Participation in an investigational drug medicinal product or medical device study within 90 days before dosing or within seven times the elimination half-life, whichever is longer
• Any abnormal skin conditions or potentially obscuring tattoos, pigmentation, or lesions in the area intended for SC injection

Where it is running

• PRA International Clinical Pharmacology Center (EDS US Clinic) — Lenexa, Kansas, United States

Full record on ClinicalTrials.gov

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