A Single-Dose Study to Investigate the Safety, Tolerability, and Pharmacokinetics (PK) of Gantenerumab Following Subcutaneous (SC) Administration in Healthy Volunteers
Completed · Phase 1 · Has a placebo group
Conditions studied: Healthy Volunteer
In brief
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.
Key facts
- Study ID
- NCT02711423
- Run by
- Hoffmann-La Roche
- People needed
- 18
- Starts
- 2016-03-31
- Expected to finish
- 2016-09-28
- Last updated by the study team
- 2019-04-10
Who can join
Age: 18 and older, up to 45. Sex: male. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Bioclinica Research — Orlando, Florida, United States
Full record on ClinicalTrials.gov
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