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

ConditionCOPD (Chronic Obstructive Pulmonary Disease)
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-55
SponsorAeroRx Therapeutics Inc.

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Male or female aged 18 to 55 years, inclusive, at the time of informed consent

Forced expiratory volume in 1 second (FEV1) > 80% of predicted normal at the Screening Visit (using the Global Lung Function Initiative [GLI] 2012 reference values)

Body mass index > 18 and < 32 kg/m2 at the Screening Visit

Able to abstain from alcohol for 24 hours prior to the Screening Visit, and prior to and after each dosing visit

Disqualifiers

Any condition or abnormality (including medical history, clinical laboratory, ECG, physical examination, or vital sign abnormalities), current or past, that, in the opinion of the Investigator or Medical Monitor, would compromise the safety of the participant, or would interfere with or complicate study procedures or assessments

Lower respiratory tract infection within 6 weeks prior to the Screening Visit

History of malignancy of any organ system, except for localized skin cancers, within 5 years prior to the Screening Visit

Major surgery (requiring general anaesthesia) within 6 weeks prior to the Screening Visit, or planned surgery through the end of the study

Trial design

Design model

Crossover

Treatments tested in this trial

  • AERO-002 (60 mcg)

    Drug

    Single dose, administered via inhalation using a standard jet nebulizer

  • Glycopyrrolate (18 mcg)

    Drug

    Single dose, administered via inhalation using pMDI

Treatment groups

24 Participants
are divided into 2 treatment groups
Group A: AERO-002Experimental treatment 1 intervention
Group B: Glycopyrrolate pMDIActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Pharmacokinetics - AUC

AUC0-t (area under the plasma concentration from time 0 to the last collection time)

Time frame
0 to 24 hours post-dose
2

Pharmacokinetics - Cmax

Cmax (maximum plasma concentration)

Time frame
0 to 24 hours post-dose

Secondary outcomes

1

Adverse events

Treatment-emergent AEs

Time frame
From the first dose to the end of the study visit at Day 7

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

AeroRx Therapeutics Inc.

Lead sponsor

Medicines Evaluation Unit Ltd

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: