Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03993171 | 31P-MRS Imaging to Assess the Effects of CNM-Au8 on Impaired Neuronal Redox State in Multiple Sclerosis. | PHASE2 | COMPLETED | 33 | — | — | Dec 19, 2019 | Jul 31, 2025 | Dec 19, 2025 | 1 | United States |
Mean change in average NAD+/NADH measured brain Redox Ratio by treatment cohort from Baseline to Week 12.
| Arm | Type | Description |
|---|---|---|
| 7.5mg CNM-Au8 | EXPERIMENTAL | 7.5mg suspension of clean-surfaced, faceted, gold nanocrystals in 120ml of sodium bicarbonate buffered water |
| 15mg CNM-Au8 | EXPERIMENTAL | 15mg suspension of clean-surfaced, faceted, gold nanocrystals in 120ml of sodium bicarbonate buffered water |
| 30mg CNM-Au8 | EXPERIMENTAL | 30mg suspension of clean-surfaced, faceted, gold nanocrystals in 120ml of sodium bicarbonate buffered water |
| 60mg CNM-Au8 | EXPERIMENTAL | 60mg suspension of clean-surfaced, faceted, gold nanocrystals in 120ml of sodium bicarbonate buffered water |
| Name | Type | Description |
|---|---|---|
| gold nanocrystals | DRUG | 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. |
Patients enrolled in Cohort 1 must meet the following Inclusion Criteria: 1. At least 18 years of age and up to 55 years (inclusive) of age at Screening. 2. Clinical diagnosis of Relapsing Multiple Sclerosis (RMS) (meeting McDonald criteria, 2017). 3. Diagnosis of MS no longer than 15 years prior t...