Evaluation of Intravenous Ascorbic Acid

Phase 1 Completed 34 enrolled University of Kansas Medical Center Thomas Jefferson University · collab

Non-randomizedSingle-groupOpen-labelTreatment

Summary

This Phase I study will be conducted in 2 parts to examine safety and pharmacokinetics of escalating doses of intravenous ascorbic acid (AA) first in healthy volunteers followed by evaluation in oncology subjects. The study will be conducted in the Program in Integrative Medicine Infusion Clinic at the University of Kansas Medical Center in conjunction with the Program in Integrative Medicine, Kansas Cancer Research Institute, Department of Pharmacy, Department of Medical Oncology, the Division of Surgical Oncology,and with consultants from the NIH, and FDA.

Timeline

Start: 2011-05
Primary completion: 2015-10
Completion: 2015-10

Publications

Chen P, Reed G, Jiang J, Wang Y, Sunega J, Dong R, Ma Y, Esparham A, Ferrell R, Levine M, Drisko J, Chen Q. Pharmacokinetic Evaluation of Intravenous Vitamin C: A Classic Pharmacokinetic Study. Clin Pharmacokinet. 2022 Sep;61(9):1237-1249. doi: 10.1007/s40262-022-01142-1. Epub 2022 Jun 25.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Vitamin C	Other / unclassified	1 g	Intravenous
Subject	Vitamin C	Other / unclassified	5 g	Intravenous
Subject	Vitamin C	Other / unclassified	10 g	Intravenous
Subject	Vitamin C	Other / unclassified	25 g	Intravenous
Subject	Vitamin C	Other / unclassified	50 g	Intravenous
Subject	Vitamin C	Other / unclassified	75 g	Intravenous
Subject	Vitamin C	Other / unclassified	100 g	Intravenous

Indications

No indication recorded.