A Single-Dose Study to Investigate the Safety, Tolerability, and Pharmacokinetics (PK) of Gantenerumab Following Subcutaneous (SC) Administration in Healthy Volunteers
- Healthy Volunteers
Completed
- United States
NCT02711423 2015-005132-17 BP30042
Trial Summary
This two-part study is designed to assess the safety, tolerability, and PK of gantenerumab in healthy volunteers. Part I (dose escalation) will randomly assign participants to receive a single blinded SC dose of gantenerumab or placebo. Part II (PK extension) will randomly assign participants to receive a single open-label SC dose of ganenerumab at different dose levels according to safety assessments from Part I.
A Single-Center, Randomized, Investigator/Subject-Blind Single-Ascending Dose, Placebo-Controlled, Parallel Study to Investigate the Safety, Tolerability, and Pharmacokinetics of Gantenerumab Following SC Administration in Healthy Subjects
Eligibility Criteria
- Healthy males 18 to 45 years of age, inclusive
- Body mass index (BMI) 20.0 to 32.0 kilograms per meter-squared (kg/m^2), inclusive
- History of cancer or any clinically significant disease affecting one of the major organ systems
- Prior administration of gantenerumab
- Clinically significant laboratory test results
- Clinically relevant history of hypersensitivity or allergic reaction following exposure to a drug, food, or environmental agent
- Known hypersensitivity to gantenerumab or excipients of study drug formulation
- Abnormal skin condition or potentially obscuring tattoo, pigmentation, or lesion in the area intended for SC injection
- Familial history of early-onset Alzheimer's disease
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