AsthmaPhase 1APkITANCT07065331
A Study of Inhaled AZD8630 in Adolescents With Asthma
A Phase 1 study testing AZD8630 and Dry powder inhaler in people with Asthma, run by AstraZeneca at 9 sites in United States.
Trial summary
The purpose of this study is to evaluate the pharmacokinetic (PK) profile, safety, tolerability, and immunogenicity of single inhaled dose of AZD8630 administered in adolescent participants with asthma as well as the safety and performance of the dry powder inhaler. Read more about this study
- Who is it for?
- Ages 12 to 17 years
- Conditions the study is for
- Asthma
- What is being tested?
- AZD8630 and Dry powder inhaler
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 9 sitesUnited States
- Study dates
- 11 Jun 2025to 19 Sep 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 12 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Physician prescribed daily use of asthma medication.
- Pre-bronchodilator Forced expiratory volume in one second (FEV1) ≥ 50% of the predicted normal value.
- Asthma control questionnaire-5 (ACQ-5) < 1.5 at Screening and Study Day 1.
Who cannot join
- History of any clinically important disease or disorder.
- History of any chronic respiratory disorders (except asthma).
- Acute exacerbation of asthma within 4 weeks of Screening.
- Life -threatening asthma.
- Completed treatment for respiratory infection with antibiotics within 4 weeks of Screening.
- History of acquired or inherited immunodeficiency disorders.
- Oral immunotherapy, including stable maintenance dose allergen-specific oral immunotherapy.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
Research Site
Bakersfield, California, 93301
Research Site
Boerne, Texas, 78006
Research Site
Lafayette, Louisiana, 70508
Research Site
Miami Lakes, Florida, 33014
Research Site
Oklahoma City, Oklahoma, 73120
Research Site
Raleigh, North Carolina, 27607
Research Site
Salt Lake City, Utah, 84107
Research Site
Spartanburg, South Carolina, 29303
Research Site
Toledo, Ohio, 43617
About this study
Official title: A Phase I, Open-label, Single-dose Study to Evaluate the Pharmacokinetics of Inhaled AZD8630 in Adolescents With Asthma
The purpose of this study is to evaluate the pharmacokinetic (PK) profile, safety, tolerability, and immunogenicity of single inhaled dose of AZD8630 administered in adolescent participants with asthma as well as the safety and performance of the dry powder inhaler.
Read the detailed description
This is a Phase 1, open label, single dose study that will be conducted in adolescent participants with asthma where the participants will receive AZD8630 administered via dry powder inhaler.
The study will be comprised of:
- A screening period.
- A treatment period.
- A post treatment period.
- A final Follow-up visit.
- Conditions
- Asthma
- Being tested
- AZD8630, Dry powder inhaler
- Keywords
- Dry powder inhaler, Anti-Thymic stromal lymphopoietin
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD8630Drug
Single inhaled dose of AZD8630 via dry powder inhaler.
Dry powder inhalerDevice
Single inhaled dose of AZD8630 via dry powder inhaler.
| Study group | Role | What they receive |
|---|---|---|
| AZD8630 | Experimental | Participants will receive single inhaled dose of AZD8630 on Day 1 via dry powder inhaler. Receives: Drug: AZD8630; Device: Dry powder inhaler |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the serum concentration-time curve from time zero to 24 hours (AUC0-24)
The AUC0-24 of AZD8630 after administered as single inhaled dose in adolescent participants with asthma will be evaluated.
Measured: Up to Day 9
Maximum observed drug concentration (Cmax)
The Cmax of AZD8630 after administered as single inhaled dose in adolescent participants with asthma will be evaluated.
Measured: Up to Day 9
Time to reach peak or maximum observed concentration (Tmax)
The Tmax of AZD8630 after administered as single inhaled dose in adolescent participants with asthma will be evaluated.
Measured: Up to Day 9
Secondary outcomes (5)
Number of participants with adverse events (AEs)
The safety and the tolerability of AZD8630 in adolescent participants with asthma will be evaluated.
Measured: From screening until Follow-up (Day 9)
Incidences of anti-drug antibodies (ADA) of AZD8630
The immunogenicity of AZD8630 in adolescent participants with asthma will be evaluated.
Measured: Day 1 and Day 9
Number of participants with AEs associated with dry powder inhaler
The safety and the performance of the dry powder inhaler device in adolescent participants with asthma will be evaluated.
Measured: Day 1
Number of participants with dry powder inhaler deficiencies
The safety and the performance of the dry powder inhaler in adolescent participants with asthma will be evaluated.
Measured: Day 1
Number of participants with dose administration confirmation
The safety and the performance of the dry powder inhaler in adolescent participants with asthma will be evaluated.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2025
- Study start11 Jun 2025
- Primary completion19 Sep 2025
- Study completion19 Sep 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07065331
- Sponsor's protocol ID
- D6830C00005
- Acronym
- APkITA
- Status last verified
- Oct 2025
- First submitted
- 11 Jun 2025
- Last updated
- 14 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- 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 requests 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 14 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Open-label, Single-dose Study to Evaluate the Pharmacokinetics of Inhaled AZD8630 in Adolescents With Asthma
- ClinicalTrials.gov ID
- NCT07065331
- Acronym / sponsor ID
- APkITA / D6830C00005
- Conditions
- Asthma
- Keywords
- Dry powder inhaler, Anti-Thymic stromal lymphopoietin
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 11 Jun 2025 (actual)
- Primary completion
- 19 Sep 2025 (actual)
- Study completion
- 19 Sep 2025 (actual)
- First posted
- 15 Jul 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.
The purpose of this study is to evaluate the pharmacokinetic (PK) profile, safety, tolerability, and immunogenicity of single inhaled dose of AZD8630 administered in adolescent participants with asthma as well as the safety and performance of the dry powder inhaler.
Detailed description
This is a Phase 1, open label, single dose study that will be conducted in adolescent participants with asthma where the participants will receive AZD8630 administered via dry powder inhaler.
The study will be comprised of:
- A screening period.
- A treatment period.
- A post treatment period.
- A final Follow-up visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AZD8630 | Experimental | Drug: AZD8630, Device: Dry powder inhalerParticipants will receive single inhaled dose of AZD8630 on Day 1 via dry powder inhaler. |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Physician prescribed daily use of asthma medication.
- Pre-bronchodilator Forced expiratory volume in one second (FEV1) ≥ 50% of the predicted normal value.
- Asthma control questionnaire-5 (ACQ-5) < 1.5 at Screening and Study Day 1.
Key exclusion criteria (7 listed)
- History of any clinically important disease or disorder.
- History of any chronic respiratory disorders (except asthma).
- Acute exacerbation of asthma within 4 weeks of Screening.
- Life -threatening asthma.
- Completed treatment for respiratory infection with antibiotics within 4 weeks of Screening.
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 |
|---|---|---|
| AZD8630Single inhaled dose of AZD8630 via dry powder inhaler. | Drug | AZD8630 |
| Dry powder inhalerSingle inhaled dose of AZD8630 via dry powder inhaler. | Device | AZD8630 |
Primary outcome
Area under the serum concentration-time curve from time zero to 24 hours (AUC0-24)
Time frame: Up to Day 9
The AUC0-24 of AZD8630 after administered as single inhaled dose in adolescent participants with asthma will be evaluated.
Maximum observed drug concentration (Cmax)
Time frame: Up to Day 9
The Cmax of AZD8630 after administered as single inhaled dose in adolescent participants with asthma will be evaluated.
Time to reach peak or maximum observed concentration (Tmax)
Time frame: Up to Day 9
The Tmax of AZD8630 after administered as single inhaled dose in adolescent participants with asthma will be evaluated.
5 secondary outcomes
Number of participants with adverse events (AEs)
Time frame: From screening until Follow-up (Day 9)
Incidences of anti-drug antibodies (ADA) of AZD8630
Time frame: Day 1 and Day 9
Number of participants with AEs associated with dry powder inhaler
Time frame: Day 1
Number of participants with dry powder inhaler deficiencies
Time frame: Day 1
Number of participants with dose administration confirmation
Time frame: Day 1
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 14 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 requests 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.
9 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 Dry powder inhaler in people with Asthma, run by AstraZeneca at 9 sites in United States.
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 3 inclusion and 7 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 14 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 9 sites in United States. 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?
Area under the serum concentration-time curve from time zero to 24 hours (AUC0-24) (time frame: Up to Day 9). The study lists 3 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 14 Oct 2025.