A Phase 1b Study of PUR1800 in Patients With COPD

Summary

This is a randomised, placebo-controlled, double-blind 3-way crossover study in which PUR1800, or placebo is dosed daily for 14 consecutive days in adult subjects with stable COPD over three discrete TPs. Subjects will be randomised to one of the following 3 treatment sequences: Sequence Period 1 Period 2 Period 3 1. Placebo PUR1800 250 μg PUR1800 500 μg 2. PUR1800 250 μg Placebo PUR1800 500 μg 3. PUR1800 250 μg PUR1800 500 μg Placebo Since this is the first study in humans in which the iSPERSE formulation is being administered, the 3 treatment sequences are designed in order to ensure that the lower dose of PUR1800 (250 μg) is administered prior to the administration of the higher dose of PUR1800 (500 μg).

Timeline

Start

2021-01-04

Primary completion

2021-12-02

Completion

2021-12-02

Drugs

Indications