Therapeutic Nanocatalysis to Slow Disease Progression of Amyotrophic Lateral Sclerosis (ALS)

PHASE2CompletedINTERVENTIONAL
Enrollment

45

Participants

Timeline

Start Date

December 19, 2019

Primary Completion Date

July 13, 2021

Study Completion Date

July 13, 2021

Conditions
Amyotrophic Lateral Sclerosis
Interventions
DRUG

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 nominal concentration of 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 60 mL HDPE containers.

DRUG

Placebo

Placebo was liquid with identical color and taste

Trial Locations (2)

2050

University of Sydney Brain and Mind Centre, Sydney

2145

Westmead Hospital, Sydney

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Clene Australia Pty Ltd.

INDUSTRY

lead

Clene Nanomedicine

INDUSTRY