Phase 1/Phase 2a Study of AERO-007 Inhalation Solution, a Nebulized LABA/LAMA Combination for Maintenance Treatment of COPD

NCT06841640 | Completed Phase 1

• 1 other identifier: AERO-007-01
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

This is a phase 1/phase 2a, single dose, crossover study conducted in two parts. Part 1: Phase 1, open-label, 4-period crossover study in 8 healthy subjects to determine the optimal dose of AERO-001 and AERO-002, the active components of AERO-007 combo bronchodilator, using the systemic pharmacokinetic (PK) profile. Part 2: Phase 2a, randomized, double-blind, placebo-controlled, 3-period crossover study in 16 subjects with COPD to determine the safety, tolerability, PK, and bronchodilator profile of AERO-007 inhalation solution administered via oral inhalation using a general-purpose nebulizer.

Conditions

COPD

Keywords

LABA; LAMA; LABA/LAMA; Inhalation; Nebulization; COPD; HVs; Single-dose; Crossover; Randomized; Placebo-controlled; Bronchodilation; FEV1; Indacaterol; Glycopyrrolate

Outcome Measures

Primary Outcomes (5)

• Pharmacokinetics - AUC

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

  Day 1

• Pharmacokinetics - Cmax

  Cmax (Maximum plasma concentration)

  Day 1

• Bronchodilation - FEV1

  Change from baseline in actual FEV1 over 12 hours

  Day 1

• Bronchodilation - FEV1 AUC

  FEV1 AUC (0-12 hours)

  Day 1

• Bronchodilation - Peak FEV1

  Peak FEV1 (0-4 hours)

  Day 1

Secondary Outcomes (1)

• Adverse events

  From the first dose to the end of study

Study Arms (7)

AERO-001 low dose

EXPERIMENTAL

Drug: AERO-001

AERO-001 high dose

EXPERIMENTAL

Drug: AERO-001

AERO-002 low dose

EXPERIMENTAL

Drug: AERO-002

AERO-002 high dose

EXPERIMENTAL

Drug: AERO-002

AERO-007 low dose

EXPERIMENTAL

Drug: AERO-007

AERO-007 high dose

EXPERIMENTAL

Drug: AERO-007

Placebo

EXPERIMENTAL

Drug: AERO-007

Interventions

AERO-001 DRUG

Open-label

Also known as: Part 1

AERO-001 high dose; AERO-001 low dose

AERO-002 DRUG

Open-label

Also known as: Part 1

AERO-002 high dose; AERO-002 low dose

AERO-007 DRUG

Double-blind

Also known as: Part 2

AERO-007 high dose; AERO-007 low dose; Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female aged 18 to 55 years
• FEV1 \> 80% of predicted normal (using the Global Lung Function Initiative GLI 2012 reference values)
• Body mass index \> 18 and \< 32 kg/m2
• Female subjects of childbearing potential must not be pregnant, breast feeding or lactating and use, with their partner, a male condom plus an approved method of highly effective birth control method
• Female subjects of childbearing potential must have a negative serum or urine pregnancy test at the Screening Visit
• Male subjects who are sexually active with a 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
• 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
• 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
• Positive serum hepatitis B surface antigen (HbsAg), hepatitis C virus antibodies (HCV Ab) or human immunodeficiency virus (HIV) 1 and/or 2 antibodies
• Chronic viral infection or immunodeficiency condition
• History of any drug and/or alcohol abuse in the past 2 years
• Current or previous use of tobacco, nicotine products or e-cigarettes within 6 months
• Smoking history of \> 5 pack years
• 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
• Donation of 450 mL of blood within 8 weeks
• Known hypersensitivity to any ingredients in the formulation for AERO-001, AERO-002, and AERO-007
• Participation in another investigational drug study within 30 days, 5 half-lives or twice the duration of the biological effect
• Cohort 2 (Subjects with COPD)

Sponsors & Collaborators

• AeroRx Therapeutics Inc.: lead

Study Sites (1)

Medicines Evaluation Unit Ltd

Manchester, United Kingdom

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Respiratory Aspiration

Condition Hierarchy (Ancestors)

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

Study Officials

• Dave Singh, MD

  Medicines Evaluation Unit Ltd

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Two cohort study. Cohort 1 is open-label, four-way crossover in 8 healthy subjects; Cohort 2 is double-blind, three-way crossover in 16 COPD patients.

Study Record Dates

• First Submitted: February 14, 2025
• First Posted: February 24, 2025
• Study Start: January 15, 2025
• Primary Completion: May 20, 2025
• Study Completion: June 7, 2025
• Last Updated: August 1, 2025

Record last verified: 2025-07

Locations

GB (1)