Lexington, Massachusetts-based Pulmatrix is evaluating PUR3100 in a Phase 1 trial using the patented iSperse technology. All subjects completed dosing of the novel orally inhaled formulation of dihydroergotamine (DHE). The company expects Phase 1 data in the fourth quarter of this year.
The trial features a double-dummy, double-blinded design. It assesses the safety, tolerability and pharmacokinetics of three dose groups of inhaled PUR3100 with intravenous (IV) placebo.
Pulmatrix is comparing its treatment to a single dose of IV DHE (DHE mesylate injection) with inhaled placebo. The evaluation includes 26 healthy subjects with at least six subjects in each of the four groups.