Healthy Volunteers Clinical Trial
Official title:
A Randomized Single and Multiple Dose Study Evaluating the Safety and Tolerability of RPh201 in Healthy Subjects and in Adults With Alzheimer's Disease
This is a dual-centre, Phase I/IIa study, in healthy subjects and subjects with AD to investigate the safety, tolerability, cognitive, and behavioural effects of RPh201. The study will be divided into three parts: A, B, and C (NOT Performed)
The primary objective of this study is to evaluate the safety and tolerability of RPh201
after single and multiple ascending doses. This study is designed with sufficient time in
between dose escalations to allow for an interim analysis of safety and tolerability data as
this is considered the safest approach to assess the effects of a compound with an undefined
mechanism and therapeutic target.
This protocol is written with some flexibility to accommodate the inherent dynamic nature of
Phase I clinical studies. Modifications to the dose, dosing regimen, and/or clinical or
laboratory procedures currently outlined below may be required to achieve the scientific
goals of the study objectives and/or to ensure appropriate safety monitoring of the study
subjects. Interim safety analyses will guide dose escalation/reduction in the trial.
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|---|---|---|---|
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