The purpose of the Phase I/II clinical trial is to evaluate the safety and tolerance of Triolex when administered orally for 28 days at three different dose levels.
The study will also evaluate the pharmacokinetics and metabolism profiles of methotrexate and Triolex when used in combination, and assess any potential anti-inflammatory activity of Triolex.
Richard Hollis, chairman and CEO of Hollis-Eden, said: “Advancing Triolex into rheumatoid arthritis patients represents years of preclinical studies that produced consistently impressive results. We look forward to a possible renaissance in the use of smarter, safer steroid hormones to treat diseases of inflammation and autoimmunity as well as other conditions associated with aging.”