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A Single-Dose Study to Investigate the Safety, Tolerability, and Pharmacokinetics (PK) of Gantenerumab Following Subcutaneous (SC) Administration in Healthy Volunteers

NCT02711423

CompletedPhase 1

Sponsor: Hoffmann-La Roche

Conditions: Healthy Volunteer

Interventions: Gantenerumab, Placebo

Countries: United States

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.

Eligibility overview

Sex: MALE

Age: 18 Years to 45 Years

Healthy volunteers: Yes

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion 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

Exclusion Criteria:

* 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

Locations (1)

Orlando, Florida, United States