A Phase 1b Study of PUR1800 in Patients With COPD

Chronic Obstructive Pulmonary Disease (COPD) Clinical Trial

Official title: A Phase 1b 3-way Crossover Study to Assess the Safety, Tolerability and Pharmacokinetics of Repeated Once Daily Doses of PUR1800 in Adult Patients With Stable Chronic Obstructive Pulmonary Disease

Status Completed

Clinical Trial 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).

Clinical Trial Description

The study design is as follows

Informed Consent: Before any study specific procedures are conducted or study requirements are expected of a patient, the patient must review and sign an IEC-approved informed consent form.

Screening: Subjects will be screened for eligibility to participate in the study within 28 days before randomisation (i.e. TP1, Day 1).

Treatment Periods:

Period 1: On Day 1 all subjects who are eligible for entry into the study will be randomised to 1 of 3 treatment sequences and receive either placebo or the lowest nominal dose of PUR1800 (PUR1800 250 μg) for 14 consecutive days.

Period 2: Following a washout period of at least 28 days after the completion of Period 1 dosing, subjects will receive a treatment other than what the subject received during Period 1 for 14 consecutive days.

Period 3: Following a washout period of at least 28 days after the completion of Period 2 dosing, subjects will receive the treatment that the subject had not received during Periods 1 or 2 (either placebo or PUR1800, 500 μg) for 14 consecutive days.

End of Study (EOS): Subjects will return to the study site 28 days after the last dose of the last TP (or in the event of early withdrawal after the last dose received, if possible) for an EOS visit. Unscheduled visits are permitted at the discretion of the investigator. ;

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease (COPD)
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

• NCT number: NCT04759807
• Study type: Interventional
• Source: Pulmatrix Inc.
• Status: Completed
• Phase: Phase 1
• Start date: January 4, 2021
• Completion date: December 2, 2021