This study was cleared to begin following the successful completion of a phase Ia study that confirmed the bio-availability of NV-52 in oral form, and its safety when administered at an acute dose.
The clinical trial will be conducted at the Pacific Private Hospital in Queensland, Australia. In the study, 12 volunteers will be administered NV-52 in a repeat dose over seven days.
The aim of the study is to extend the safety data by looking at the use of the drug on a long-term basis, as well as testing the ability of the drug to change certain inflammatory markers in the serum. Novogen expects that completion of the study in human volunteers will enable the commencement of the phase II development program, in which patients with inflammatory bowel diseases will be treated with the drug to determine its utility in prolonging disease remission.
Formal toxicology testing has indicated that NV-52 is a completely non-toxic compound, causing no adverse effects in animals. NV-52 has also been demonstrated to have no genotoxic or mutagenic effects.