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

NCT07802730 | Not Yet Recruiting Phase 1 FDA Drug

• 1 other identifier: AERO-007-03
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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)

Keywords

COPD; Inhalation; Nebulization; Pharmacokinetics; Drug delivery; Healthy subjects; LABA; LAMA; LABA+LAMA combination; Phase 1; Glycopyrrolate; Indacaterol; Randomized; Crossover; Open-label

Outcome Measures

Primary Outcomes (2)

• Pharmacokinetics - AUC

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

  0 to 24 hours post-dose

• Pharmacokinetics - Cmax

  Cmax (maximum plasma concentration)

  0 to 24 hours post-dose

Secondary Outcomes (1)

• Adverse events

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

Study Arms (2)

AERO-002

EXPERIMENTAL

Drug: AERO-002 (60 mcg)

Glycopyrrolate pMDI

ACTIVE COMPARATOR

Drug: Glycopyrrolate (18 mcg)

Interventions

AERO-002 (60 mcg) DRUG

Single dose, administered via inhalation using a standard jet nebulizer

AERO-002

Glycopyrrolate (18 mcg) DRUG

Single dose, administered via inhalation using pMDI

Glycopyrrolate pMDI

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• Female participants of childbearing potential must not be pregnant, breast feeding, or lactating, and heterosexual female participants of childbearing potential must agree to use, with their partner, a male condom plus an approved method of highly effective birth control from the time of informed consent and for 30 days following the last administered dose
• Female participants of childbearing potential must have a negative serum or urine pregnancy test at the Screening Visit and a negative urine pregnancy test prior to dosing at each Treatment Visit
• Male participants who are sexually active with a female partner of childbearing potential must use, with their partner, a male condom plus an approved method of highly effective contraception from the time of informed consent and for 30 days following the last administered dose
• Participants must agree not to donate semen or ova/oocytes from the time of informed consent and for 30 days following the last administered dose
• Participants must be in good health as determined by medical history, physical examination, vital signs, 12-lead ECG, and clinical laboratory assessments at the time of screening, as judged by the Investigator
• Willing and able to provide written informed consent

You may not qualify if:

• 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
• Positive serum hepatitis B surface antigen (HbsAg), hepatitis C virus antibodies (HCV Ab) or human immunodeficiency virus (HIV) 1 and/or 2 antibodies at the Screening Visit
• Chronic viral infection or immunodeficiency condition
• History of any drug and/or alcohol abuse in the past 2 years prior to the Screening Visit
• Current or previous use of tobacco, nicotine products, or e-cigarettes within 6 months prior to the Screening Visit through the End of Study Visit
• Smoking history of \> 5 pack years
• Positive urine cotinine test at the Screening Visit or prior to dosing at each Treatment Visit
• Regular alcohol consumption in males \>21 units per week and females \>14 units per week
• Positive urine drugs of abuse test and/or alcohol breath test at the Screening Visit or prior to dosing at each Treatment Visit that cannot be accounted for by concomitant medication, in the opinion of the Investigator
• Donation of ≥ 450 mL of blood within 8 weeks of the Screening Visit
• History of intolerance or hypersensitivity to any of the ingredients in the formulation for AERO-002 or other aerosol medications
• Participation in another investigational drug study within 30 days of the last dose, 5 average terminal elimination half-lives (T1/2) or twice the duration of the biological effect, whichever is longer, prior to the Screening Visit

Sponsors & Collaborators

• AeroRx Therapeutics Inc.: lead
• Medicines Evaluation Unit Ltd: collaborator

Study Sites (1)

Medicines Evaluation Unit Ltd

Manchester, United Kingdom

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Respiratory Aspiration

Interventions

Glycopyrrolate

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Respiration Disorders

Intervention Hierarchy (Ancestors)

Quaternary Ammonium Compounds; Amines; Organic Chemicals; Onium Compounds; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Central Study Contacts

Ahmet Tutuncu, MD, PhD

CONTACT

+1-858-750-4717; Ahmet.Tutuncu@AeroRxTherapeutics.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2026
• First Posted: September 3, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: September 3, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)