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Evaluation of Ascorbate-Meglumine Therapeutic for SRS

NCT06433791 · Status: ENROLLING_BY_INVITATION · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2024-09-19

No results posted yet for this study

Summary

Phase 1, Single-Center, Dose-Escalating, Open-Label, Safety Clinical Trial of Parenteral Ascorbate-Meglumine as a Novel Magnetic Resonance Imaging (MRI)-guided Adjunctive Therapeutic for Stereotactic Radiosurgery (SRS)

Conditions

  • Safety

Interventions

DRUG

Ascorbate-Meglumine

Ascorbate, meglumine and sodium salt made by combining 375 mM sodium ascorbate,125 mM ascorbic acid and 125 mM meglumine in sterile water for injection

Sponsors & Collaborators

  • Duke Clinical Research Institute

    collaborator OTHER

  • LadeRx LLC

    lead INDUSTRY

Principal Investigators

  • John Kirkpatrick, MD · Duke Health

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-09-09
Primary Completion
2025-05-17
Completion
2025-09-09
FDA Drug
Yes

Countries

  • United States

Study Locations

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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 NCT06433791 on ClinicalTrials.gov