On January 21, 2019, Shenox completed the administration of first MDD patient in the SHX-001 First in Human trial at the Maryland site in US. At this time, it was only two months since Shenox obtained the IND approval from FDA.
SHX-001 is a transdermal patch product for MDD with global intellectual property rights. This trial is a single blind, crossover design and multicenter clinical trial, including two dosage groups and a placebo. Harvard Medical School/Massachusetts General Hospital is the PI unit. The trial will evaluate the PK of SHX-001 and its efficacy and safety as antidepressant.
From FDA’s approval to the first patient’s dosing, it took Shenox only two months to efficiently complete all kinds of complicated paper work, including the application of local IRB, electronic database preparation, patients screening, distribution of clinical trial products, etc. This period also includes the Christmas and New Year Holidays in US.