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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
Basic Details
Male and Female
18 to 60 Years
yes
Study Identifier
YP40254
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?
[email protected]
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 study 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 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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For the latest version of this information please go to www.forpatients.roche.com