A phase I trial assessing the safety, tolerability, pharmacokinetic and pharmacodynamic characteristics of single-dose Auron Misheil therapy in healthy male subjects

作者：Scheele J^*; Diergarten K; Drevs J; Niazi F R

来源：Journal of Clinical Pharmacy and Therapeutics, 2013, 38(1): 3-11.

DOI：10.1111/j.1365-2710.2009.01087.x

• Auron Misheil therapy
• cancer
• phase I

Background and objective: Auron Misheil therapy (AMT) is a combination of widely used pharmaceuticals and herbal components that has been used since the 1980s as a supportive therapy, mainly in end-stage cancer patients on a compassionate basis. This phase I study was conducted to assess the safety, tolerability, and pharmacokinetic (PK) and pharmacodynamic (PD) properties of AMT in a controlled trial environment. Methods: The study was conducted in a single rising dose, double-blind, placebo-controlled design. Three groups of eight healthy male volunteers received one of three doses of AMT (0.011, 0.033 or 0.066 mL AMT/kg body weight intramuscularly; n = 6 per group) or placebo (n = 2 per group). Results and discussion: Auron Misheil therapy was shown to be well tolerated, revealing no severe or serious adverse events. There were no unexpected PK or PD results for any of the three components of AMT. Conclusions: These data provide important PK, PD and safety data for AMT, and support further controlled clinical investigation in patients with different types of cancer as an option for supportive care.

• 出版日期2013-2