A Study to Assess the Impact of Speed and Site of Subcutaneous Injection on Pain, Tolerability, Safety, and Pharmacokinetics of Gantenerumab in Healthy Participants

  • Healthy Volunteers
Trial Status:

Completed

This trial runs in
Cities
  • Shawnee
Trial Identifier:

NCT02882009 WP39322

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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.

      Results Disclaimer

      Trial Summary

      The purpose of this randomized, open-label, parallel-group, placebo-controlled study is to assess pain following subcutaneous (SC) administration of gantenerumab as a high-concentration liquid formulation (HCLF) at different injection speeds. The total duration of the study for each healthy participant will be up to approximately 21 weeks.

      Hoffmann-La Roche Sponsor
      Phase 1 Phase
      NCT02882009 , WP39322 Trial Identifier
      Gantenerumab, Placebo Treatments
      Healthy Volunteer Condition
      Official Title

      A Single-Center, Randomized, Open-Label, Parallel-Group, Placebo-Controlled, Cross-Over Study To Investigate the Impact of Speed of Injection and Site of Injection on Pain, Tolerability, Safety, and Pharmacokinetics Following Subcutaneous Administration of Gantenerumab in Healthy Volunteers

      Eligibility Criteria

      All Gender
      ≥ 40 Years & ≤ 80 Years Age
      Accepts Healthy Volunteers Healthy Volunteers
      Inclusion Criteria
      • Healthy male and female participants (healthy status is defined by the absence of evidence of any active or chronic disease following a detailed medical and surgical history, a complete physical examination including vital signs, 12-lead electrocardiogram, hematology, blood chemistry, coagulation, serology, and urinalysis)
      • Body mass index between 18.0 and 30.0 kilograms per meter squared (kg/m^2), inclusive
      • Female participants of childbearing potential must commit to use two acceptable forms of contraception during the study and until at least 6 months after the follow-up visit
      Exclusion Criteria
      • History of any clinically significant gastrointestinal, renal, hepatic, broncho-pulmonary, neurological, psychiatric, cardiovascular, endocrinological, hematological or allergic disease, metabolic disorder, cancer, or cirrhosis
      • History or suspicion of drugs of abuse or alcohol addiction
      • Smokers who smoke more than 10 cigarettes per day or equivalent amount of tobacco as determined by history
      • Pregnant or lactating women
      • Positive result on hepatitis B virus (HBV), hepatitis C virus (HCV), or Human immunodeficiency virus (HIV)-1 and -2
      • Any familial history of early onset Alzheimer's disease
      • Prior administration of gantenerumab
      • Participation in an investigational drug medicinal product or medical device study within 90 days before dosing or within seven times the elimination half-life, whichever is longer
      • Any abnormal skin conditions or potentially obscuring tattoos, pigmentation, or lesions in the area intended for SC injection

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