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A Study to Assess the Impact of Speed and Site of Subcutaneous Injection on Pain, Tolerability, Safety, and Pharmacokinetics of Gantenerumab in Healthy Participants
- Healthy Volunteers
Please note that the recruitment status of the trial at your site may differ from the overall study status because some study sites may recruit earlier than others.
Trial Status:
Completed
This trial runs in
City
- Shawnee
Trial Identifier:
NCT02882009 WP39322
Trial Summary
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.
Hoffmann-La Roche
Sponsor
Phase 1
Phase
NCT02882009, WP39322
Trial Identifier
Gantenerumab, Placebo
Treatments
Healthy Volunteer
Condition
Official Title
A Single-Center, Randomized, Open-Label, Parallel-Group, Placebo-Controlled, Cross-Over Study To Investigate the Impact of Speed of Injection and Site of Injection on Pain, Tolerability, Safety, and Pharmacokinetics Following Subcutaneous Administration of Gantenerumab in Healthy Volunteers
Eligibility Criteria
All
Gender
≥ 40 Years & ≤ 80 Years
Age
Accepts Healthy Volunteers
Healthy Volunteers
Inclusion Criteria
- 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
Exclusion Criteria
- 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
For the latest version of this information please go to www.forpatients.roche.com