A study to investigate the processing by the body, safety, and side effects of gantenerumab in healthy Chinese participants following a single dose

A single-center, open-label, Phase I study to investigate the pharmacokinetics, safety, and tolerability of gantenerumab in healthy Chinese participants following single subcutaneous administration of a high-concentration liquid formulation in the abdomen

  • Healthy Volunteers
Please note that the recruitment status of the trial at your site may differ from the overall study status because some study sites may recruit earlier than others.
Trial Status:

Active, not recruiting

This trial runs in
Country
  • China
Trial Identifier:

YP40254

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      The source of the below information is public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc.. It has been summarised and edited into simpler language. For more information about this clinical trial see the For Expert tab on the specific ForPatients page or follow these links to https://clinicaltrials.gov and/or https://euclinicaltrials.eu and/or https://www.isrctn.com.

      The below information is taken directly from public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc., and has not been edited.

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      Trial Summary

      Alzheimer’s disease (AD) is the most common form of dementia, accounting for 60%−70% of cases. The prevalence of AD increases with age, with a global prevalence of 5%− 8% in people 60 years and older. Because of its increasing prevalence, long duration, and high cost of care, AD is expected to be a major public health problem for decades to come.
      AD is thought to be caused by an abnormal build-up of proteins in the brain resulting in a loss of brain cells. Treatments targeting the processing and deposition of protein may alter the progression of AD. Gantenerumab (RO4909832) is an antibody that binds specifically to amyloid-beta (a brain protein fragment and prime suspect in AD), promoting its clearance. This single-dose study in healthy participants has been designed to support the development of gantenerumab for the treatment of patients with AD in China.

      YP40254 Trial Identifier
      Male and Female Gender
      18 to 60 Years Age
      yes Healthy Volunteers

      Who can participate?
      Healthy Chinese male and female volunteers

      What does the study involve?
      On day one, participants will receive a single dose of gantenerumab as two injections, one in the lower quadrant and one in the upper quadrant of the abdomen. Blood levels of gantenerumab are measured at pre-dose, Day 1, 2, 3, 4, 5, 6, 7, 8, 12, 21, 29, 43, 64 and 85.

      What are the possible benefits and risks of participating?
      Gantenerumab has been well-tolerated in patients with AD. The dosage is within the range of recently conducted clinical trials in healthy participants; all tested doses were considered safe and well-tolerated. There are two identified risks for the compound: amyloid-related imaging abnormalities (ARIA) are abnormal differences seen in brain imaging of AD patients, observed following repeated treatment in patients with AD, and integrated stress response (ISR). In previous single-dose studies of gantenerumab, in participants with AD, ARIA has not been observed. As with any medicinal product, the potential for a hypersensitivity reaction with gantenerumab cannot be excluded. Therefore, the participants will be closely monitored during injection and for 24 hours after treatment, and medications for the treatment of hypersensitivity reactions will be available. Overall, based on previous studies with gantenerumab and the careful monitoring of safety parameters within this study, the risks for the participants in this study are considered acceptable.
      No therapeutic benefit is anticipated for the participants participating in this study. The results from this study may guide the future development of gantenerumab for the treatment of patients with AD.

      Where is the study run from?
      Huashan Hospital Affiliated to Fudan University (China)

      When is the study starting and how long is it expected to run for?
      June 2020 to October 2021

      Who is funding the study?
      Genentech, Inc. (USA)

      Who is the main contact?
      global-roche-genentech-trials@gene.com

      Trial Summary

      Alzheimer’s disease (AD) is the most common form of dementia, accounting for 60%−70% of cases. The prevalence of AD increases with age, with a global prevalence of 5%− 8% in people 60 years and older. Because of its increasing prevalence, long duration, and high cost of care, AD is expected to be a major public health problem for decades to come.
      AD is thought to be caused by an abnormal build-up of proteins in the brain resulting in a loss of brain cells. Treatments targeting the processing and deposition of protein may alter the progression of AD. Gantenerumab (RO4909832) is an antibody that binds specifically to amyloid-beta (a brain protein fragment and prime suspect in AD), promoting its clearance. This single-dose study in healthy participants has been designed to support the development of gantenerumab for the treatment of patients with AD in China.

      YP40254 Trial Identifier
      gantenerumab Treatments

      Eligibility Criteria

      Male and Female Gender
      18 to 60 Years Age
      yes Healthy Volunteers

      For the latest version of this information please go to www.forpatients.roche.com

       

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