A double-blind, randomized, placebo-controlled, Phase 1 safety and tolerability, and pharmacokinetics study

Occurring Dates
to
Participant Duration
4 Days / 3 Nights (in house stay) + 1 Follow up visits
State of study
South Australia
Overview

The study drug being evaluated is called ANAVEX3-71 and is being developed by a company called Anavex Life Sciences Corporation (Anavex). ANAVEX3-71 stimulates sigma-1 receptors (S1R) and muscarinic acetylcholine receptors (M1) in the body, and this double action is proposed to slow the progression and relieve the symptoms of neurodegenerative disorders such as Alzheimer’s disease and Frontotemporal dementia. Previous animal studies conducted by Anavex on ANAVEX3-71 suggested positive results with a well-tolerated safety profile. Promising results has prompted further development of stimulators of S1Rs.

In this trial, we are evaluating the safety and tolerability of an investigational drug. An investigational drug (also referred to as “study drug”) is one which has not been approved by any regulatory body. You should be aware that the test medication used in this study is experimental and has not yet been approved by the TGA (Therapeutic Goods Administration) in Australia, or any other Regulatory Agency worldwide responsible for approving study drugs. This trial will be the first time the preparation of this drug will be tested in humans. 

We are looking for males only between the age range of 18 – 35 to participate in this study.

Panel 2b consists of six healthy males to be dosed at a single dosing occasion. There will be two treatment groups, one consisting of active study drug, and the other consisting of placebo. A placebo looks exactly like the study drug but contains no active medication. Treatment groups will be assigned at random after screening assessments are completed: Four participants will receive study drug, while two participants will receive placebo. Dosing will only commence after safety evaluations have occurred. You will be required to stay in the clinical unit for three nights. In addition to looking at the safety and tolerability of the study drug, we also want to evaluate the amount of study drug in your blood after it is administered.

This is the first study in which this study drug is being taken by humans. Prior to this study, no human studies have been conducted with ANAVEX3-71. Because of this, at the single dosing occasion, two participants will be dosed first (called “sentinel dosing”), followed by the remaining four participants. These four participants will be dosed a minimum of 24 hours later. The study physician will tell you which group you are in. This will also be determined at random.

Further information

The study is being conducted at CMAX Clinical Research in Adelaide, South Australia. If you'd like to learn more, let us know via e-mail to [email protected] research team will be in touch.

This study has been approved by the Bellberry Human Research Ethics Committee (reference number: HREC2020-03-251).

Study Address
Level 5, 18a North Terrace Adelaide
South Australia 5000
Full Name
Francesca Bell
Institute
CMAX Clinical Research
Phone Number
0481 733 652