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

  • Healthy Volunteers
Trial Status:

Completed

This trial runs in
Countries
  • United States
Trial Identifier:

NCT02711423 2015-005132-17 BP30042

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      The source of the below information is the publicly available website ClinicalTrials.gov. It has been summarised and edited into simpler language.

      The below information is taken directly from the publicly available website ClinicalTrials.gov within a week of any updates, and has not been edited.

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      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.

      Hoffmann-La Roche Sponsor
      Phase 1 Phase
      NCT02711423 , BP30042 , 2015-005132-17 Trial Identifier
      Gantenerumab, Placebo Treatments
      Healthy Volunteer Condition
      Official Title

      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

      Male Gender
      ≥ 18 Years & ≤ 45 Years Age
      Accepts Healthy Volunteers Healthy Volunteers
      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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