AsthmaPhase 1NCT06795906
A Safety, Pharmacokinetic, and Pharmacodynamic Study of Once Daily Inhaled AZD8630 in Adults With Asthma
A Phase 1 study testing AZD8630 and Saphira device in people with Asthma, run by AstraZeneca at 3 sites in Germany.
Trial summary
This is a randomised, placebo-controlled, double-blinded, sponsor-unblinded study to assess the safety, pharmacokinetic (PK), and pharmacodynamic (PD) effect of AZD8630 in adult participants with asthma on medium-to-high dose inhaled corticosteroids (ICS) and long-acting beta-agonists (LABA). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Asthma
- What is being tested?
- AZD8630 and Saphira device
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 3 sitesGermany
- Study dates
- 28 Jan 2025to 27 Jun 2025
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1 Participants who have documented physician-diagnosis of asthma for at least 12 months, as evidenced by any of the following:
- Post-bronchodilator (BD) reversibility of FEV1 ≥ 12% and ≥ 200 milliliters (mL) within 5 years prior to Visit 1, at Visit 1 or
- Peak expiratory flow (PEF) average daily variability > 10% over a 2-week period within 5 years prior to Visit 1, or
- Variability of FEV1 > 12% and 200 mL between any 2 clinical visits within 5 years prior to Visit 1, or
- Positive bronchial challenge test within 5 years prior to Visit 1. A positive test is defined as a fall in FEV1 from pre-challenge of ≥ 20% with standard doses of methacholine or ≥ 5% with standardised hyperventilation, hypertonic saline, or mannitol challenge, or
- Positive exercise challenge test within 5 years prior to Visit 1. A positive test is defined as a fall in FEV1 of > 10% and > 200 mL from pre-challenge, or
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- Significant increase in lung function after 4 weeks of Inhaled Corticosteroids (ICS) anti-inflammatory treatment within 5 years prior to Visit 1, defined as an increase in FEV1 > 12% and 200 mL (or PEF by > 20%).
- 3 Treated with medium or high dose ICS (as per GINA 2023) in combination with long-acting beta-agonists (LABA) (GINA step 4 or 5 therapy); the dose of ICS must be stable for at least 30 days prior to Visit 1. The ICS can be contained within an ICS-LABA fixed-dose combination product.
- Treatment with additional asthma controller therapies (eg, long-acting muscarinic-agonists) at a stable dose ≥ 30 days prior to Visit 1 is allowed.
- 4 Asthma Control Questionnaire-6 (ACQ-6) score in the range 0.75-3 at both screening and randomisation.
- 5 Pre-bronchodilator FEV1 ≥ 40%. 6 FeNO ≥ 30 parts per billion (ppb) at both screening and randomisation. 7 At least 70% compliance with usual asthma background medication during the screening period (14 days prior to randomisation) based on the daily asthma ePROs. At least 70% compliance with electronically recorded participant reported outcomes (ePRO) device completion during the screening period (14 days prior to randomisation). This is defined as completing the ePRO any 10 mornings and 10 evenings in the last 14 days prior to randomisation.
- 8 Minimum 70% compliance with PEF measurements during the screening period (14 days prior to randomisation). This is defined as performing PEF for any 10 mornings and any 10 evenings in the last 14 days prior to randomisation.
- 9 Body mass index (BMI) within the range 18 to 35 kilograms per meter (kg/m2) inclusive and weight at least 45 kg at the time of signing the informed consent.
Who cannot join
- Life-threatening asthma defined as a history of significant asthma episode(s) involving intubation, respiratory arrest, hypoxic seizures, or asthma-related syncopal episode(s).
- Completed treatment for respiratory infection and/or asthma exacerbation with systemic corticosteroids and/or antibiotics in the 4 weeks prior to Visit 1 or during the screening period.
- Clinically important pulmonary disease other than asthma; including but not limited to participants with co-existent chronic obstructive pulmonary disease (COPD).
- Any disorder, including, but not limited to, cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, haematological, psychiatric, or major physical impairment that is not stable in the opinion of the investigator and could:
- Affect the safety of the participant throughout the study.
- Influence the findings of the study or the interpretation.
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- Impede the participant's ability to complete the entire study.
- Participants who, in the opinion of the investigator, have evidence of active tuberculosis (TB) or are currently on treatment for active or latent TB. Investigation for active or latent TB with interferon gamma release assay (IGRA) and/or chest X-ray should only be considered if deemed clinically indicated by the Principal Investigator.
- Medical history of or treatment for hepatitis B or hepatitis C, except for cured hepatitis C, as defined by:
- Positive test for hepatitis B surface antigen (HBsAg).
- Positive test for anti- hepatitis B core antibody (HBc Ab): Participants who test positive for anti-HBc Ab but negative for HBsAg may be enrolled if their hepatitis B virus (HBV) DNA test result is negative.
- Positive test for anti-hepatitis C antibody: Participants who test positive for anti-hepatitis C antibody may be enrolled if their hepatitis C viral ribonucleic acid (RNA) test result is negative in the absence of cirrhosis.
- Participants with known human immunodeficiency virus (HIV) or with a positive HIV test at screening.
- Any other clinically relevant abnormal findings in laboratory testing including haematology and clinical chemistry, on vital signs, electrocardiogram (ECG), or physical examination between consent and randomisation, that in the opinion of the investigator or medical monitor, might compromise the safety of the participant in the study or interfere with evaluation of the study intervention. Abnormal findings include, but are not limited to:
- Alanine aminotransferase/transaminase (ALT) or aspartate aminotransferase/transaminase AST > 2 × upper limit of normal (ULN).
- Total bilirubin (TBL) > 1.5 × ULN (unless due to Gilbert's disease).
- Evidence of chronic liver disease.
- Congenital long QT syndrome or prolonged QT corrected for heart rate by Fridericia (QTcF) > 470 ms or history of QT prolongation associated with other medications that required discontinuation of that medication.
- Current untreated or uncontrolled arrhythmia (eg, multifocal premature ventricular contractions, bigeminy, trigeminy, ventricular tachycardia). Note: Participants with clinically significant sinus nodal disease/bradycardia or Type 2 second- or third-degree atrioventricular (AV) block can be included if treated with pacemaker.
- Participants with recent (within 3 months of Visit 1) myocardial infarction, unstable angina pectoris, stroke, percutaneous coronary intervention and coronary artery bypass grafting (within 6 months of Visit 1).
- Current smokers, former smokers with > 10 pack-years history, or former smokers who stopped smoking < 6 months before Visit 1 (including all forms of tobacco, e-cigarettes (vaping), and other recreational drugs including marijuana).
- History of current or previous alcohol or drug misuse in the 12 months prior to screening. The use of oral cannabis is permitted.
- Current diagnosis of cancer or unresectable cancer that has not been in complete remission for at least 5 years prior to Visit 1. Note: Squamous cell and basal cell carcinomas of the skin and cervical carcinoma-in-situ that have been treated and considered cured at the time of enrolment are not exclusionary.
- History of documented immune complex disease (Type III hypersensitivity reactions) to monoclonal antibody (mAb) administration.
- History of hypersensitivity or anaphylaxis to any components of AZD8630 formulation.
- History of anaphylaxis or ongoing clinically important serious allergy, as judged by the investigator, or history of anaphylaxis that required the use of epinephrine/adrenaline or hospitalisation.
- A helminth parasitic infection diagnosed within 24 weeks of screening that has not been treated or has not responded to standard of care therapy.
- Use of the following medicines within the specified time before screening:
- Treatment with marketed or investigational biologics for asthma or immunological disease within 4 months or a minimum of 5 half-lives, whichever is longer, prior to the screening visit.
- Systemic steroids within 4 weeks prior to the screening visit. Note: Intranasal steroid use is permitted, provided that there has been a stable treatment regimen for 4 weeks.
- Live, attenuated, or mRNA vaccine in the 4 weeks prior to screening visit.
- Any systemic immunosuppressive therapy within 3 months of screening visit until the end of the follow-up period.
- Use of allergen immunotherapy within 3 months of screening visit, except for stable maintenance dose allergen-specific immunotherapy started 4 weeks prior to screening visit.
- Bronchial thermoplasty in the last 12 months prior to screening visit.
- Receipt of immunoglobulin or blood products within 4 weeks prior to screening visit.
- Participation in another clinical study with a study intervention administered within 5 half-lives or in accordance with local regulations (whichever is longer) prior to screening.
Trial locations and contacts
3 sites in 1 country.
Germany3 sites
Research Site
Ahrensburg, 22926
Research Site
Berlin, 10119
Research Site
Mainz, 55128
About this study
Official title: A Study to Assess the Safety, Pharmacokinetics, and Pharmacodynamics of AZD8630, Administered Once Daily Via Inhalation, for 2 Weeks, in Adults With Asthma on Medium-to-high Dose Inhaled Corticosteroids and Long-acting Beta-agonists
This is a randomised, placebo-controlled, double-blinded, sponsor-unblinded study to assess the safety, pharmacokinetic (PK), and pharmacodynamic (PD) effect of AZD8630 in adult participants with asthma on medium-to-high dose inhaled corticosteroids (ICS) and long-acting beta-agonists (LABA).
Read the detailed description
The purpose of this study is to assess the safety, PK, and PD of AZD8630 compared to placebo in participants with asthma and elevated fractional exhaled nitric oxide (FeNO) on a combination of medium-to-high dose ICS and LABA medications.
The study will comprise of:
- A Screening/Enrollment Period of up to 14 to 28 days before dosing.
- A Treatment Period/End of Treatment Visit. On Day 1, participants will be randomised to AZD8630 or corresponding placebo. Study intervention will be self-administered once daily up to Day 14. Participants will return to the study site for clinical and safety assessments on Day 7 and clinical and safety assessments and PK sampling on Day 14.
- A Follow-up Visit 1 week after last dose.
- Conditions
- Asthma
- Being tested
- AZD8630, Placebo, Saphira device
- Keywords
- Inhaled corticosteroids, Long-acting beta-agonists
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD8630Drug
AZD8630 will be administered via dry powder inhalation (DPI).
PlaceboOther
Placebo will be administered via DPI.
Saphira deviceDevice
AZD8630 or placebo will be administered to participants via Saphira device.
| Study group | Role | What they receive |
|---|---|---|
| AZD8630 Dose A | Experimental | Participants will self-administer AZD8630 Dose A daily from Day 1 up to Day 14. Receives: Drug: AZD8630; Device: Saphira device |
| Placebo | Placebo comparator | Participants will self-administer corresponding placebo daily from Day 1 up to Day 14. Receives: Other: Placebo; Device: Saphira device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of adverse events (AEs) and serious adverse events (SAEs)
To assess the safety and tolerability of AZD8630 Dose A daily (QD) in participants with asthma on medium-to-high dose ICS and LABA.
Measured: From Screening (Day -28) to Follow up (Day 21)
Number of adverse events leading to discontinuation (DAEs)
To assess the safety and tolerability of AZD8630 Dose A QD in participants with asthma on medium-to-high dose ICS and LABA.
Measured: From Day 1 to Day 14
Area under the plasma concentration curve from zero to the last quantifiable concentration (AUClast)
To assess the PK of AZD8630 Dose A QD in participants with asthma on medium-to-high dose ICS and LABA.
Measured: Day 1, Day 14 and Follow up (Day 21)
Maximum observed plasma (peak) drug concentration (Cmax)
To assess the PK of AZD8630 Dose A QD in participants with asthma on medium-to-high dose ICS and LABA.
Measured: Day 1, Day 14 and Follow up (Day 21)
Secondary outcomes (5)
Change from baseline in fractional exhaled nitric oxide (FeNO) at Weeks 1 and 2
To evaluate the PD of AZD8630 Dose A QD in participants with asthma on medium-to-high dose ICS and LABA.
Measured: From Screening (Day -28) to Follow up (Day 21)
Incidence of anti-drug antibodies (ADAs) in serum
To characterise the immunogenicity of AZD8630 Dose A QD in participants with asthma on medium-to-high dose ICS and LABA.
Measured: Day 1, Day 14 and Follow up (Day 21)
Incidence of AEs and SAEs associated with the Saphira device
To assess the safety and performance of the Saphira device.
Measured: Day 1 to Day 14
Incidence of Saphira device deficiencies (DDs)
To assess the safety and performance of the Saphira device.
Measured: Day 1 to Day 14
Incidence of participant confirmation of dose administration following inhalation
To assess the safety and performance of the Saphira device.
Measured: Day 1 to Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2025
- Study start28 Jan 2025
- Primary completion27 Jun 2025
- Study completion27 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Parexel
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06795906
- Sponsor's protocol ID
- D6830C00004
- Status last verified
- Sep 2025
- First submitted
- 22 Jan 2025
- Last updated
- 3 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Assess the Safety, Pharmacokinetics, and Pharmacodynamics of AZD8630, Administered Once Daily Via Inhalation, for 2 Weeks, in Adults With Asthma on Medium-to-high Dose Inhaled Corticosteroids and Long-acting Beta-agonists
- ClinicalTrials.gov ID
- NCT06795906
- Acronym / sponsor ID
- D6830C00004
- Conditions
- Asthma
- Keywords
- Inhaled corticosteroids, Long-acting beta-agonists
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Collaborators
- Parexel
- Study start
- 28 Jan 2025 (actual)
- Primary completion
- 27 Jun 2025 (actual)
- Study completion
- 27 Jun 2025 (actual)
- First posted
- 28 Jan 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 randomised, placebo-controlled, double-blinded, sponsor-unblinded study to assess the safety, pharmacokinetic (PK), and pharmacodynamic (PD) effect of AZD8630 in adult participants with asthma on medium-to-high dose inhaled corticosteroids (ICS) and long-acting beta-agonists (LABA).
Detailed description
The purpose of this study is to assess the safety, PK, and PD of AZD8630 compared to placebo in participants with asthma and elevated fractional exhaled nitric oxide (FeNO) on a combination of medium-to-high dose ICS and LABA medications.
The study will comprise of:
- A Screening/Enrollment Period of up to 14 to 28 days before dosing.
- A Treatment Period/End of Treatment Visit. On Day 1, participants will be randomised to AZD8630 or corresponding placebo. Study intervention will be self-administered once daily up to Day 14. Participants will return to the study site for clinical and safety assessments on Day 7 and clinical and safety assessments and PK sampling on Day 14.
- A Follow-up Visit 1 week after last dose.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AZD8630 Dose A | Experimental | Drug: AZD8630, Device: Saphira deviceParticipants will self-administer AZD8630 Dose A daily from Day 1 up to Day 14. |
| Placebo | Placebo comparator | Other: Placebo, Device: Saphira deviceParticipants will self-administer corresponding placebo daily from Day 1 up to Day 14. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 1 Participants who have documented physician-diagnosis of asthma for at least 12 months, as evidenced by any of the following:
- Post-bronchodilator (BD) reversibility of FEV1 ≥ 12% and ≥ 200 milliliters (mL) within 5 years prior to Visit 1, at Visit 1 or
- Peak expiratory flow (PEF) average daily variability > 10% over a 2-week period within 5 years prior to Visit 1, or
- Variability of FEV1 > 12% and 200 mL between any 2 clinical visits within 5 years prior to Visit 1, or
- Positive bronchial challenge test within 5 years prior to Visit 1. A positive test is defined as a fall in FEV1 from pre-challenge of ≥ 20% with standard doses of methacholine or ≥ 5% with standardised hyperventilation, hypertonic saline, or mannitol challenge, or
Key exclusion criteria (36 listed)
- Life-threatening asthma defined as a history of significant asthma episode(s) involving intubation, respiratory arrest, hypoxic seizures, or asthma-related syncopal episode(s).
- Completed treatment for respiratory infection and/or asthma exacerbation with systemic corticosteroids and/or antibiotics in the 4 weeks prior to Visit 1 or during the screening period.
- Clinically important pulmonary disease other than asthma; including but not limited to participants with co-existent chronic obstructive pulmonary disease (COPD).
- Any disorder, including, but not limited to, cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, haematological, psychiatric, or major physical impairment that is not stable in the opinion of the investigator and could:
- Participants who, in the opinion of the investigator, have evidence of active tuberculosis (TB) or are currently on treatment for active or latent TB. Investigation for active or latent TB with interferon gamma release assay (IGRA) and/or chest X-ray should only be considered if deemed clinically indicated by the Principal Investigator.
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 |
|---|---|---|
| AZD8630AZD8630 will be administered via dry powder inhalation (DPI). | Drug | AZD8630 Dose A |
| PlaceboPlacebo will be administered via DPI. | Other | Placebo |
| Saphira deviceAZD8630 or placebo will be administered to participants via Saphira device. | Device | AZD8630 Dose A, Placebo |
Primary outcome
Number of adverse events (AEs) and serious adverse events (SAEs)
Time frame: From Screening (Day -28) to Follow up (Day 21)
To assess the safety and tolerability of AZD8630 Dose A daily (QD) in participants with asthma on medium-to-high dose ICS and LABA.
Number of adverse events leading to discontinuation (DAEs)
Time frame: From Day 1 to Day 14
To assess the safety and tolerability of AZD8630 Dose A QD in participants with asthma on medium-to-high dose ICS and LABA.
Area under the plasma concentration curve from zero to the last quantifiable concentration (AUClast)
Time frame: Day 1, Day 14 and Follow up (Day 21)
To assess the PK of AZD8630 Dose A QD in participants with asthma on medium-to-high dose ICS and LABA.
Maximum observed plasma (peak) drug concentration (Cmax)
Time frame: Day 1, Day 14 and Follow up (Day 21)
To assess the PK of AZD8630 Dose A QD in participants with asthma on medium-to-high dose ICS and LABA.
5 secondary outcomes
Change from baseline in fractional exhaled nitric oxide (FeNO) at Weeks 1 and 2
Time frame: From Screening (Day -28) to Follow up (Day 21)
Incidence of anti-drug antibodies (ADAs) in serum
Time frame: Day 1, Day 14 and Follow up (Day 21)
Incidence of AEs and SAEs associated with the Saphira device
Time frame: Day 1 to Day 14
Incidence of Saphira device deficiencies (DDs)
Time frame: Day 1 to Day 14
Incidence of participant confirmation of dose administration following inhalation
Time frame: Day 1 to Day 14
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 3 Oct 2025.
- Individual participant dataSharing planned: Yes. Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
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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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AZD8630 and Saphira device in people with Asthma, run by AstraZeneca at 3 sites in Germany.
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 13 inclusion and 36 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 3 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Germany. 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. Some participants in this study may receive a placebo. 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?
Number of adverse events (AEs) and serious adverse events (SAEs) (time frame: From Screening (Day -28) to Follow up (Day 21)). The study lists 4 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 3 Oct 2025.