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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AZD8630 | Experimental | Participants will receive single inhaled dose of AZD8630 on Day 1 via dry powder inhaler. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AZD8630 | Drug | Single inhaled dose of AZD8630 via dry powder inhaler. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | Up to Day 9 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with adverse events (AEs) | The safety and the tolerability of AZD8630 in adolescent participants with asthma will be evaluated. | From screening until Follow-up (Day 9) |
| Incidences of anti-drug antibodies (ADA) of AZD8630 |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Bakersfield | California | 93301 | United States | ||
| Research Site |
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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AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please refer to our disclosure commitment at:
https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secureresearchenvironmentVivli.org. A Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
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| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| ID | Term |
|---|---|
| D058995 | Dry Powder Inhalers |
| ID | Term |
|---|---|
| D009330 | Nebulizers and Vaporizers |
| D004864 | Equipment and Supplies |
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| Dry powder inhaler |
| Device |
Single inhaled dose of AZD8630 via dry powder inhaler. |
|
The immunogenicity of AZD8630 in adolescent participants with asthma will be evaluated.
| 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. | 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. | 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. | Day 1 |
| Miami Lakes |
| Florida |
| 33014 |
| United States |
| Research Site | Lafayette | Louisiana | 70508 | United States |
| Research Site | Raleigh | North Carolina | 27607 | United States |
| Research Site | Toledo | Ohio | 43617 | United States |
| Research Site | Oklahoma City | Oklahoma | 73120 | United States |
| Research Site | Spartanburg | South Carolina | 29303 | United States |
| Research Site | Boerne | Texas | 78006 | United States |
| Research Site | Salt Lake City | Utah | 84107 | United States |
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |