Phosphagenics announced that it has begun a Phase I clinical trial of its transdermal insulin delivery product, TPM-02/Insulin. The drug is being developed as a new way of administering insulin to diabetics, and this trial follows on from the successful preclinical trials that were reported in May.
The primary objective of this study is to assess the safety and tolerability of delivering insulin through the skin. Blood glucose and insulin levels will be measured as secondary outcomes. In the proposed study, 20 healthy male volunteers ages 18 to 45 will be randomly assigned to receive either TPM-02/Insulin or a placebo gel, applied in a single dose directly to the skin. Patients will then be monitored for a period of 48 hours.
The trial, which is being conducted in Australia in accordance with International Conference on Harmonisation standards, is expected to be completed by the end of July.