COPDPhase 1/2NCT06841640
Phase 1/Phase 2a Study of AERO-007 Inhalation Solution, a Nebulized LABA/LAMA Combination for Maintenance Treatment of COPD
A Phase 1/2 study testing AERO-001, AERO-002 and AERO-007 in people with COPD, run by AeroRx Therapeutics Inc. at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- COPD
- What is being tested?
- AERO-001, AERO-002 and AERO-007
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 15 Jan 2025to 7 Jun 2025
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- 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
- Male or female aged 40 to 75 years
- Clinical diagnosis of COPD according to the Global Initiative for Chronic Obstructive Lung Disease [GOLD] Report, 2024 for at least 12 months
- Post-bronchodilator spirometry (within 30 minutes following 4 puffs of salbutamol) demonstrating the following:
- FEV1 > 40 and < 80% of predicted normal (using the Global Lung Function Initiative GLI 2012 reference values)
- FEV1/FVC ratio < 0.70
- ≥ 150 mL increase from pre-bronchodilator FEV1
- Ability to change current COPD therapy and discontinue long-acting bronchodilators for the duration of the study and short-acting bronchodilators for 8 hours prior to dosing at each treatment visit
- Current or former-smokers with at least 10 pack-year smoking history (eg, at least 1 pack/day for 10 years, 10 packs/day for 1 year)
- Ability to perform reproducible spirometry according to the American Thoracic Society (ATS)/European Respiratory Society (ERS) guidelines
- 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
- Willing and able to provide written informed consent
Who cannot join
- 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
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- 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)
- Female subjects who are pregnant, breast-feeding or lactating
- Current evidence or recent history of significant comorbidities; including cardiovascular disease (such as myocardial infarction, cardiac failure, uncontrolled hypertension, or life-threatening arrhythmias), uncontrolled diabetes, neurologic, psychiatric, hepatic, renal, immunological, or haematological conditions within the last 6 months
- Positive serum HbsAg, HCV Ab or HIV 1 and/or 2 antibodies
- Lower respiratory tract infection within 6 weeks
- Recent history of hospitalization due to an exacerbation of airway disease or acute worsening of COPD requiring antibiotic or corticosteroid treatment within 6 months
- Other respiratory disorders: Current diagnosis of predominant asthma, lung cancer, bronchiectasis, interstitial lung disease, tuberculosis, pulmonary hypertension, or other non-specific pulmonary diseases
- Prior lung volume reduction surgery or history of chest/lung irradiation
- Daily oxygen therapy for > 12 hours per day
- Body mass index >35 kg/m2
- Current or recent history of medical conditions that are contraindicated for use of an inhaled LAMA (such as urinary retention or bladder neck obstruction type symptoms, prostatic hypertrophy, or narrow-angle glaucoma) within the last 6 months
- Current or recent history (previous 12 months) of excessive use or abuse of alcohol (males >21 units per week and females >14 units per week)
- Current evidence or history (within the past 2 years) of abusing legal drugs or use of illegal drugs or substances
- Donation of 450 mL of blood within 8 weeks
- Major surgery (requiring general anaesthesia) within 6 weeks
- History of malignancy of any organ system, except for localized skin cancers, within 5 years
- 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, whichever is longer
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Two-part, Single-dose, Dose-finding Study to Assess the Safety, Tolerability, Pharmacokinetics and Bronchodilator Effects of AERO-007 Inhalation Solution Using a General Purpose Nebulizer in Healthy Volunteers and Subjects With COPD
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.
Read the detailed description
According to the Global Initiative for Chronic Obstructive Lung Disease [GOLD] guidelines, combination of a long-acting beta-agonist (LABA) bronchodilator and a long-acting muscarinic antagonist (LAMA) bronchodilator is the preferred choice for initial pharmacotherapy for COPD patients with high symptom severity, frequently experiencing breathlessness and patients with high exacerbation risk.
Although there are currently multiple LABA+LAMA combination bronchodilators available in an inhaler (MDI, DPI, and SMI), a significant number of COPD patients, generally high risk and older patients, do not receive optimal benefit from inhalers. Nebulized delivery provides an effective alternative for these patients. Currently there are no approved LABA+LAMA combinations available for nebulization delivery.
AERO-007 is a propriety inhalation solution formulation of fixed-dose combination of LABA+LAMA (indacaterol, AERO-001 and glycopyrrolate, AERO-002) under development for delivery using a general purpose nebulizer.
This study consists of two parts. In Part 1 (Phase 1), 8 healthy subjects will be randomized to receive single doses of 4 study treatments in an open-label, crossover design (low and high doses of AERO-001 and AERO-002). In Part 2 (Phase 2a), 16 subjects with clinically stable COPD will be randomized to receive single doses of 3 study treatments in a double-blind, crossover design (low and high doses of AERO-007 and placebo) administered by random sequence.
- Conditions
- COPD
- Being tested
- AERO-001, AERO-002, AERO-007
- Keywords
- LABA, LAMA, LABA/LAMA, Inhalation, Nebulization, COPD, HVs, Single-dose, Crossover, Randomized, Placebo-controlled, Bronchodilation, FEV1, Indacaterol, Glycopyrrolate
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AERO-001Drug
Also called Part 1
Open-label
AERO-002Drug
Also called Part 1
Open-label
AERO-007Drug
Also called Part 2
Double-blind
| Study group | Role | What they receive |
|---|---|---|
| AERO-001 low dose | Experimental | Not described Receives: Drug: AERO-001 |
| AERO-001 high dose | Experimental | Not described Receives: Drug: AERO-001 |
| AERO-002 low dose | Experimental | Not described Receives: Drug: AERO-002 |
| AERO-002 high dose | Experimental | Not described Receives: Drug: AERO-002 |
| AERO-007 low dose | Experimental | Not described Receives: Drug: AERO-007 |
| AERO-007 high dose | Experimental | Not described Receives: Drug: AERO-007 |
| Placebo | Experimental | Not described Receives: Drug: AERO-007 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics - AUC
AUC0-t (Area under the plasma concentration from time 0 to the last collection time)
Measured: Day 1
Pharmacokinetics - Cmax
Cmax (Maximum plasma concentration)
Measured: Day 1
Bronchodilation - FEV1
Change from baseline in actual FEV1 over 12 hours
Measured: Day 1
Bronchodilation - FEV1 AUC
FEV1 AUC (0-12 hours)
Measured: Day 1
Bronchodilation - Peak FEV1
Peak FEV1 (0-4 hours)
Measured: Day 1
Secondary outcomes (1)
Adverse events
Treatment-emergent AEs
Measured: From the first dose to the end of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2025
- Study start15 Jan 2025
- Primary completion20 May 2025
- Study completion7 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- AeroRx Therapeutics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dave Singh, MD, Principal investigator, Medicines Evaluation Unit Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06841640
- Sponsor's protocol ID
- AERO-007-01
- Status last verified
- Jul 2025
- First submitted
- 14 Feb 2025
- Last updated
- 1 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Two-part, Single-dose, Dose-finding Study to Assess the Safety, Tolerability, Pharmacokinetics and Bronchodilator Effects of AERO-007 Inhalation Solution Using a General Purpose Nebulizer in Healthy Volunteers and Subjects With COPD
- ClinicalTrials.gov ID
- NCT06841640
- Acronym / sponsor ID
- AERO-007-01
- Conditions
- COPD
- Keywords
- LABA, LAMA, LABA/LAMA, Inhalation, Nebulization, COPD, HVs, Single-dose
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- AeroRx Therapeutics Inc.Industry (pharma, biotech, devices)
- Study start
- 15 Jan 2025 (actual)
- Primary completion
- 20 May 2025 (actual)
- Study completion
- 7 Jun 2025 (actual)
- First posted
- 24 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
According to the Global Initiative for Chronic Obstructive Lung Disease [GOLD] guidelines, combination of a long-acting beta-agonist (LABA) bronchodilator and a long-acting muscarinic antagonist (LAMA) bronchodilator is the preferred choice for initial pharmacotherapy for COPD patients with high symptom severity, frequently experiencing breathlessness and patients with high exacerbation risk.
Although there are currently multiple LABA+LAMA combination bronchodilators available in an inhaler (MDI, DPI, and SMI), a significant number of COPD patients, generally high risk and older patients, do not receive optimal benefit from inhalers. Nebulized delivery provides an effective alternative for these patients. Currently there are no approved LABA+LAMA combinations available for nebulization delivery.
AERO-007 is a propriety inhalation solution formulation of fixed-dose combination of LABA+LAMA (indacaterol, AERO-001 and glycopyrrolate, AERO-002) under development for delivery using a general purpose nebulizer.
This study consists of two parts. In Part 1 (Phase 1), 8 healthy subjects will be randomized to receive single doses of 4 study treatments in an open-label, crossover design (low and high doses of AERO-001 and AERO-002). In Part 2 (Phase 2a), 16 subjects with clinically stable COPD will be randomized to receive single doses of 3 study treatments in a double-blind, crossover design (low and high doses of AERO-007 and placebo) administered by random sequence.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 7
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- 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
Key exclusion criteria (32 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AERO-001Also: Part 1Open-label | Drug | AERO-001 high dose, AERO-001 low dose |
| AERO-002Also: Part 1Open-label | Drug | AERO-002 high dose, AERO-002 low dose |
| AERO-007Also: Part 2Double-blind | Drug | AERO-007 high dose, AERO-007 low dose, Placebo |
Primary outcome
Pharmacokinetics - AUC
Time frame: Day 1
AUC0-t (Area under the plasma concentration from time 0 to the last collection time)
Pharmacokinetics - Cmax
Time frame: Day 1
Cmax (Maximum plasma concentration)
Bronchodilation - FEV1
Time frame: Day 1
Change from baseline in actual FEV1 over 12 hours
Bronchodilation - FEV1 AUC
Time frame: Day 1
FEV1 AUC (0-12 hours)
Bronchodilation - Peak FEV1
Time frame: Day 1
Peak FEV1 (0-4 hours)
1 secondary outcome
Adverse events
Time frame: From the first dose to the end of study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dave Singh, MD principal investigator
Medicines Evaluation Unit Ltd
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing AERO-001, AERO-002 and AERO-007 in people with COPD, run by AeroRx Therapeutics Inc. at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacokinetics - AUC (time frame: Day 1). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2025.