A Study to Assess the Impact of Speed and Site of Subcutaneous Injection on Pain, Tolerability, Safety, and Pharmacokinetics of Gantenerumab in Healthy Participants
Status: | Completed |
---|---|
Conditions: | Healthy Studies |
Therapuetic Areas: | Other |
Healthy: | No |
Age Range: | 40 - 80 |
Updated: | 6/14/2018 |
Start Date: | August 31, 2016 |
End Date: | March 22, 2017 |
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
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.
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.
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
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