Phase I Clinical Trial to Evaluate the Safety and Tolerability of Oral SN-1 Extract Formulation in Healthy Thai Volunteers

Abstract

Abstract

The human immunodeficiency virus (HIV) is one of the greatest current worldwide health threats.With the difficulties faced from the adverse effects of drugs used to treat HIV and the emergenceof drug resistance, a new drug or medicinal herb is urgently needed. Previous study by the Departmentof Medical Science, Ministry of Public Health, Thailand, has demonstrated that the SN-1 extracts ofthe Thai medicinal herb “Khailung” (Phyllanthus sp) is a potent inhibitor of the enzyme HIV-1 reversetranscriptase in vitro. We conducted a study comparing an oral formulation of a 500 mg/day dose ofSN-1 extract given for 14 days, and an oral formulation of SN-1 extract 1,000 mg/day for 14 days, todetermine safety and tolerability. The study population consisted of 16 healthy Thai volunteersresiding in Bangkok. Routine laboratory and physical examinations were performed every day duringdrug administration, and weekly during follow-up for 28 days after final drug administration, toobserve any adverse effects. The results showed no finding of clinically significant abnormalities orchanges from the baseline for routine laboratory, vital signs and body weights compared on anyfollow-up day. In addition, no clinical adverse reactions or drug-related effects were observed duringthe study. We conclude that the oral formulation of SN-1 extract was well-tolerated. The clinicalpharmacology of the SN-1 extract should be further studied to explore the potential for using thisdrug to treat HIV-1.

Keywords: HIV, SN-1, Khailung, Phyllanthus sp, HIV-1 reverse transcriptase