Closely-held Zucara Therapeutics dosed the first subject in its Phase 1 trial of ZT-01, a once-daily somatostatin inhibitor designed to prevent insulin-induced hypoglycemia.
The first, single ascending dose portion of the study will enroll 40 healthy volunteers who will receive one of five escalating doses of ZT-01. The second, multiple ascending dose portion of the study will enroll 24 subjects with Type 1 diabetes (T1D) who will receive multiple escalating doses of ZT-01.
The study will help define ZT-01’s safety profile and establish doses to be used in an additional planned Phase 1 study to show the effect on glucagon during hypoglycemia in T1D patients.
“Insulin-induced hypoglycemia is an underrecognized condition that causes fear and anxiety among diabetes patients and their loved ones,” Michael Midmer, Zucara’s CEO, said in a statement.
“We are thrilled to enter the clinic with ZT-01 and look forward to gathering safety and pharmacodynamics data on this promising candidate, which we believe has the potential to improve disease management for the millions of patients who are at risk for dangerous hypoglycemic episodes,” he added.
