A Single-Dose Study to Investigate the Safety, Tolerability, and Pharmacokinetics (PK) of Gantenerumab Following Subcutaneous (SC) Administration in Healthy Volunteers
- Healthy Volunteers
- United States
NCT02711423 2015-005132-17 BP30042
The source of the below information is public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc.. It has been summarised and edited into simpler language. For more information about this clinical trial see the For Expert tab on the specific ForPatients page or follow these links to https://clinicaltrials.gov and/or https://euclinicaltrials.eu and/or https://www.isrctn.com.
The below information is taken directly from public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc., and has not been edited.
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
- 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
For the latest version of this information please go to www.forpatients.roche.com