NCT04081714

Intermediate Expanded Access Protocol CNMAu8.EAP03

Intermediate Expanded Access Protocol With CNM-Au8 for Multiple Sclerosis

• Status: Temporarily Not Available
• Phase: —
• Study type: Expanded Access
• Enrollment: —
• Sponsor: Clene Nanomedicine · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

Summary

This is a single-center intermediate expanded access program to provide access to the investigational product, CNM-Au8, up to 25 participants diagnosed with Multiple Sclerosis.

Detailed description

This is an intermediate expanded access program to provide access to the investigational product, CNM-Au8, for up to 25 participants. All participants will receive open label treatment with CNM-Au8 30 mg orally. The safety and efficacy of CNM-Au8 treatment in MS participants will be evaluated. Scheduled visits will occur at the baseline visit, week 6 visit, week 12, and then every 12-weeks thereafter at the participating clinic(s). Optional remote data collection via telemedicine and/or home healthcare visits are permitted commencing with the week 12 visit. Clinical safety laboratory monitoring including urinalysis, a chemistry panel (e.g., CMP) and a hematology panel (e.g., CBC) will be conducted at the screening/baseline visit and at each scheduled visit incorporating safety laboratory assessments. Participants who meet the inclusion criteria and none of the exclusionary criteria may be enrolled into the EAP. The program and participant visits will continue for a total of 96-weeks of treatment. Four weeks following treatment discontinuation, a safety follow-up visit will be conducted. Investigational product may be shipped by the site to participants who do not attend an in-clinic visit. The EAP may be discontinued at the Sponsor's sole discretion if: (i) there is insufficient funding to maintain the EAP, (ii) the Sponsor is unable to produce sufficient supply of the investigational product to meet clinical trial obligations, (iii) CNM-Au8 receives marketing authorization within the United States, or (iv) continued support of the EAP risks further clinical development of CNM-Au8.

Conditions

• Multiple Sclerosis

Interventions

Type	Name	Description
DRUG	CNM-Au8	CNM-Au8 is an aqueous suspension of clean surfaced faceted nanocrystals consisting of gold atoms self-organized into crystals of various geometrical shapes (hexagonal bi-pyramid, pentagonal bipyramid, tetrahedron, decahedron, planar spheroids). Highly pure elemental Au nanocrystals are suspended in USP purified deionized water buffered with 0.546 mg/mL (6.5 mM) sodium bicarbonate (NaHCO3) nominally concentrated to 0.5 mg/L (500 ppm). CNM-Au8 will be administered orally in volumes of 60 mL from single-dose HDPE containers. Participants will orally receive 30 mg of CNM-Au8 once daily.

Timeline

• First posted: 2019-09-09
• Last updated: 2025-12-24

Locations

1 site across 1 country: United States