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A Phase 1b Study of PUR1800 in Patients With COPD

NCT04759807 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2022-06-27

No results posted yet for this study

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).

Conditions

  • Chronic Obstructive Pulmonary Disease (COPD)

Interventions

DRUG

Placebo Comparator

The placebo designed for administration in the proposed clinical study consists of a dry powder composed of the same excipients as the active (sodium sulfate, mannitol and polysorbate 80), pre-metered into HPMC capsules at the same 5 mg powder fill weight as the active formulations. Subjects will receive 14 doses administered once daily in the morning.

DRUG

PUR1800 250 ug

The PUR1800 drug product intended for use in the proposed clinical study comprises bulk powder containing 5 wt% or 10 wt% RV1162 pre-metered into HPMC capsules for oral delivery via a passive DPI. The capsules contain 5 milligrams (mg) of the powder formulation, corresponding to a 250 μg nominal dose strength of RV1162. Subjects will receive 14 doses administered once daily in the morning.

DRUG

PUR1800 500 ug

The PUR1800 drug product intended for use in the proposed clinical study comprises bulk powder containing 5 wt% or 10 wt% RV1162 pre-metered into HPMC capsules for oral delivery via a passive DPI. The capsules contain 5 milligrams (mg) of the powder formulation, corresponding to a 500 μg nominal dose strength of RV1162. Subjects will receive 14 doses administered once daily in the morning.

Sponsors & Collaborators

  • Pulmatrix Inc.

    lead INDUSTRY

Principal Investigators

  • Dave Singh, Prof · The Medicines Evaluation Unit

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
40 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-04
Primary Completion
2021-12-02
Completion
2021-12-02

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04759807 on ClinicalTrials.gov