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Intermediate Expanded Access Protocol CNMAu8.EAP03

NCT04081714 · Status: TEMPORARILY_NOT_AVAILABLE · Type: EXPANDED_ACCESS

Last updated 2025-12-24

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • University of Texas, Southwestern Medical Center at Dallas

    collaborator OTHER

  • Clene Nanomedicine

    lead INDUSTRY

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04081714 on ClinicalTrials.gov