NCT01513967

A Randomized SAD and MAD Study Evaluating the Safety and Tolerability of RPh201 in Healthy Subjects and in Adults With Alzheimer's Disease

A Randomized Single and Multiple Dose Study Evaluating the Safety and Tolerability of RPh201 in Healthy Subjects and in Adults With Alzheimer's Disease

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 39 (actual)
• Sponsor: Regenera Pharma Ltd · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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)

Detailed description

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.

Conditions

• Healthy Volunteers
• Moderate to Severe Alzheimer Patients

Interventions

Type	Name	Description
DRUG	RPh201, botanical drug product	SC administration at varying doses
DRUG	Placebo	SC administration at varying doses

Timeline

• Start date: 2012-01-01
• Primary completion: 2015-06-01
• Completion: 2015-06-01
• First posted: 2012-01-20
• Last updated: 2020-03-23
• Results posted: 2020-03-23

Locations

2 sites across 1 country: Canada