73
Participants
Start Date
November 23, 2018
Primary Completion Date
April 27, 2022
Study Completion Date
July 12, 2022
CNM-Au8
CNM-Au8 is a dark red/purple-colored liquid formulation consisting of a stable suspension of faceted clean surfaced elemental gold nanocrystals in buffered deionized water with a concentration of up to 0.5 mg/mL of gold. The formulation is buffered by sodium bicarbonate present at a concentration of 0.546 mg/mL. There are no other excipients. The drug product is formulated to be taken orally and will be provided in single dose HDPE containers. The study doses vary by the concentration of gold nanocrystals per milliliter in a volume of 60 mL.
Placebo
Placebo is liquid with identical color and taste
John Hunter Hospital, New Lambton Heights
Alfred Health, Melbourne
Princess Alexandria Hospital, Woolloongabba
Menzies Institute for Medical Research, Hobart
UT Southwestern Medical Center, Dallas
Sydney Brain Mind Centre, Sydney
University of British Columbia, Vancouver
Lead Sponsor
Clene Australia Pty Ltd.
INDUSTRY
Clene Nanomedicine
INDUSTRY