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Phase 1 PK Study of AERO-007, an Inhaled LABA+LAMA Combination for Nebulization Delivery in COPD Patients

NCT07802730 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2026-09-03

No results posted yet for this study

Summary

This is a phase 1, single-dose, 2-period crossover study in healthy volunteers to compare the systemic pharmacokinetic (PK) profile of inhaled AERO-002 versus inhaled active comparator product.

Conditions

  • COPD (Chronic Obstructive Pulmonary Disease)

Interventions

DRUG

AERO-002 (60 mcg)

Single dose, administered via inhalation using a standard jet nebulizer

DRUG

Glycopyrrolate (18 mcg)

Single dose, administered via inhalation using pMDI

Sponsors & Collaborators

  • Medicines Evaluation Unit Ltd

    collaborator INDUSTRY

  • AeroRx Therapeutics Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-09-30
Primary Completion
2026-12-31
Completion
2026-12-31
FDA Drug
Yes

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 NCT07802730 on ClinicalTrials.gov