A Single-Dose Study to Investigate the Safety, Tolerability, and Pharmacokinetics (PK) of Gantenerumab Following Subcutaneous (SC) Administration in Healthy Volunteers
| Status: | Completed |
|---|---|
| Conditions: | Healthy Studies |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - 45 |
| Updated: | 4/17/2018 |
| Start Date: | March 31, 2016 |
| End Date: | September 28, 2016 |
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
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.
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.
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
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