COPD (Chronic Obstructive Pulmonary Disease)Phase 1NCT07802730
Phase 1 PK Study of AERO-007, an Inhaled LABA+LAMA Combination for Nebulization Delivery in COPD Patients
A Phase 1 study testing AERO-002 (60 mcg) and Glycopyrrolate (18 mcg) in people with COPD (Chronic Obstructive Pulmonary Disease), run by AeroRx Therapeutics Inc. at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- COPD (Chronic Obstructive Pulmonary Disease)
- What is being tested?
- AERO-002 (60 mcg) and Glycopyrrolate (18 mcg)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 21 Sep 2026to 9 Oct 2026
- Phase
- Phase 1
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
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- 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
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 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
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- 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
- History or high risk of noncompliance with study visits and procedures or unsuitable for entry into the study, at the discretion of the Investigator
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Pharmacokinetics of Glycopyrrolate (AERO-002) in AERO-007 Combination Product Versus Active Comparator Inhalation Glycopyrrolate Product in Healthy Volunteers
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.
Read the detailed description
AERO-007 is a propriety inhalation solution formulation of fixed-dose combination of LABA+LAMA (indacaterol and glycopyrrolate) for delivery using a general-purpose nebulizer device.
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 handheld inhalers, 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 where disease management is sub optimal. To date there are no approved LABA+LAMA combinations available by nebulization.
In this phase 1 study, 24 healthy volunteers will be randomized to receive single doses of two study treatments (AERO-002 and active comparator) in a crossover design administered by random sequence. Study assessments will be performed pre- and post-dose for 24 hours. Treatment visits will be separated by a washout period of 7 days.
- Being tested
- AERO-002 (60 mcg), Glycopyrrolate (18 mcg)
- Keywords
- COPD, Inhalation, Nebulization, Pharmacokinetics, Drug delivery, Healthy subjects, LABA, LAMA, LABA+LAMA combination, Phase 1, Glycopyrrolate, Indacaterol, Randomized, Crossover, Open-label
- 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-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
| Study group | Role | What they receive |
|---|---|---|
| AERO-002 | Experimental | Not described Receives: Drug: AERO-002 (60 mcg) |
| Glycopyrrolate pMDI | Active comparator | Not described Receives: Drug: Glycopyrrolate (18 mcg) |
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: 0 to 24 hours post-dose
Pharmacokinetics - Cmax
Cmax (maximum plasma concentration)
Measured: 0 to 24 hours post-dose
Secondary outcomes (1)
Adverse events
Treatment-emergent AEs
Measured: From the first dose to the end of the study visit at Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2026
- Study start21 Sep 2026
- Primary completion9 Oct 2026
- Study completion9 Oct 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPD (Chronic Obstructive Pulmonary Disease)Studies 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- AeroRx Therapeutics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Medicines Evaluation Unit Ltd
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07802730
- Sponsor's protocol ID
- AERO-007-03
- Status last verified
- Oct 2026
- First submitted
- 29 Aug 2026
- Last updated
- 15 Oct 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Pharmacokinetics of Glycopyrrolate (AERO-002) in AERO-007 Combination Product Versus Active Comparator Inhalation Glycopyrrolate Product in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT07802730
- Acronym / sponsor ID
- AERO-007-03
- Keywords
- COPD, Inhalation, Nebulization, Pharmacokinetics, Drug delivery, Healthy subjects, LABA, LAMA
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- AeroRx Therapeutics Inc.Industry (pharma, biotech, devices)
- Collaborators
- Medicines Evaluation Unit Ltd
- Study start
- 21 Sep 2026 (actual)
- Primary completion
- 9 Oct 2026 (actual)
- Study completion
- 9 Oct 2026 (actual)
- First posted
- 3 Sep 2026 (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, 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.
Detailed description
AERO-007 is a propriety inhalation solution formulation of fixed-dose combination of LABA+LAMA (indacaterol and glycopyrrolate) for delivery using a general-purpose nebulizer device.
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 handheld inhalers, 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 where disease management is sub optimal. To date there are no approved LABA+LAMA combinations available by nebulization.
In this phase 1 study, 24 healthy volunteers will be randomized to receive single doses of two study treatments (AERO-002 and active comparator) in a crossover design administered by random sequence. Study assessments will be performed pre- and post-dose for 24 hours. Treatment visits will be separated by a washout period of 7 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AERO-002 | Experimental | Drug: AERO-002 (60 mcg) |
| Glycopyrrolate pMDI | Active comparator | Drug: Glycopyrrolate (18 mcg) |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (16 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 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
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-002 (60 mcg)Single dose, administered via inhalation using a standard jet nebulizer | Drug | AERO-002 |
| Glycopyrrolate (18 mcg)Single dose, administered via inhalation using pMDI | Drug | Glycopyrrolate pMDI |
Primary outcome
Pharmacokinetics - AUC
Time frame: 0 to 24 hours post-dose
AUC0-t (area under the plasma concentration from time 0 to the last collection time)
Pharmacokinetics - Cmax
Time frame: 0 to 24 hours post-dose
Cmax (maximum plasma concentration)
1 secondary outcome
Adverse events
Time frame: From the first dose to the end of the study visit at Day 7
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 15 Oct 2026.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AERO-002 (60 mcg) and Glycopyrrolate (18 mcg) in people with COPD (Chronic Obstructive Pulmonary Disease), 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 10 inclusion and 16 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 15 Oct 2026. 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 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.
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: 0 to 24 hours post-dose). The study lists 2 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 15 Oct 2026.