Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06529419 | A Dose Range-Finding Study to Assess the Efficacy and Safety of Multiple Dose Levels of AZD8630 in Adults With Uncontrolled Asthma at Risk of Exacerbations | PHASE2 | COMPLETED | 537 | — | — | Aug 30, 2024 | Feb 4, 2026 | Mar 2, 2026 | 196 | United States, Argentina +21 |
| NCT07065331 | A Study of Inhaled AZD8630 in Adolescents With Asthma | PHASE1 | COMPLETED | 10 | — | — | Jun 11, 2025 | Sep 19, 2025 | Oct 14, 2025 | 9 | United States |
| NCT06795906 | A Safety, Pharmacokinetic, and Pharmacodynamic Study of Once Daily Inhaled AZD8630 in Adults With Asthma | PHASE1 | COMPLETED | 24 | — | — | Jan 28, 2025 | Jun 27, 2025 | Oct 3, 2025 | 3 | Germany |
| NCT05110976 | A Study to Investigate the Safety, Tolerability and Effects of AZD8630 in Healthy Subjects and Subjects With Asthma on Inhaled Corticosteroids and Long-acting Beta-agonists | PHASE1 | COMPLETED | 170 | — | — | Dec 16, 2021 | Aug 2, 2023 | Aug 30, 2023 | 29 | United States, Germany +1 |
The CompEx Asthma is a composite endpoint for exacerbations that captures asthma-worsening episodes based on combination of diary events (worsening in daily PEF, asthma symptoms and rescue medication use) plus severe asthma exacerbation events. Diary events are defined by threshold and slope criteria using the following morning/evening diary variables: * PEF * Asthma symptom score (0 to 3) * Use of rescue medication
The AUC0-24 of AZD8630 after administered as single inhaled dose in adolescent participants with asthma will be evaluated.
The Cmax of AZD8630 after administered as single inhaled dose in adolescent participants with asthma will be evaluated.
The Tmax of AZD8630 after administered as single inhaled dose in adolescent participants with asthma will be evaluated.
To assess the safety and tolerability of AZD8630 Dose A daily (QD) in participants with asthma on medium-to-high dose ICS and LABA.
To assess the safety and tolerability of AZD8630 Dose A QD in participants with asthma on medium-to-high dose ICS and LABA.
To assess the PK of AZD8630 Dose A QD in participants with asthma on medium-to-high dose ICS and LABA.
To assess the PK of AZD8630 Dose A QD in participants with asthma on medium-to-high dose ICS and LABA.
Safety and tolerability of inhaled AZD8630 in healthy participants and participants with asthma will be assessed.
tmax of AZD8630 following IV administration of single dose of AZ8630 in healthy participants will be assessed
tlast of AZD8630 following IV administration of single dose of AZ8630 in healthy participants will be assessed
Cmax of AZD8630 following IV administration of single dose of AZ8630 in healthy participants will be assessed.
AUC(0-24) of AZD8630 following IV administration of single dose of AZ8630 in healthy participants will be assessed.
AUClast of AZD8630 following IV administration of single dose of AZ8630 in healthy participants will be assessed.
AUCinf of AZD8630 following IV administration of single dose of AZ8630 in healthy participants will be assessed.
λz of AZD8630 following IV administration of single dose of AZ8630 in healthy participants will be assessed.
t1/2λz) of AZD8630 following IV administration of single dose of AZ8630 in healthy participants will be assessed.
MRTinf of AZD8630 following IV administration of single dose of AZ8630 in healthy participants will be assessed.
CL of AZD8630 following IV administration of single dose of AZ8630 in healthy participants will be assessed.
Vss of AZD8630 following IV administration of single dose of AZ8630 in healthy participants will be assessed.
Vz of AZD8630 following IV administration of single dose of AZ8630 in healthy participants will be assessed.
Safety and tolerability of IV AZD8630 in healthy participants will be assessed.
| Arm | Type | Description |
|---|---|---|
| AZD8630 dose A | EXPERIMENTAL | Inhaled AZD8630 administered at a dose A |
| AZD8630 dose B | EXPERIMENTAL | Inhaled AZD8630 administered at a dose B |
| AZD8630 dose C | EXPERIMENTAL | Inhaled AZD8630 administered at a dose C |
| Placebo | PLACEBO_COMPARATOR | Inhaled placebo |
| AZD8630 | EXPERIMENTAL | Participants will receive single inhaled dose of AZD8630 on Day 1 via dry powder inhaler. |
| Part A1: SAD (AZD8630) | EXPERIMENTAL | Healthy participants will receive single inhaled doses 1 to 5 of AZD8630. |
| Part A1: IV (AZD8630) | EXPERIMENTAL | Healthy participants will receive a single IV dose of AZD8630. |
| Part A1: IV (Placebo) | PLACEBO_COMPARATOR | Healthy participants will receive single IV dose of Placebo. |
| Part A2: SAD (AZD8630) | EXPERIMENTAL | Healthy participants of Chinese and Japanese ethnicity will receive single inhaled dose 5 of AZD8630. |
| Part A3: MAD (AZD8630) | EXPERIMENTAL | Healthy participants will receive once daily inhaled doses 3, 4, and 5 of AZD8630. |
| Part A4: MAD (AZD8630) | EXPERIMENTAL | Healthy participants of Chinese and Japanese ethnicity will receive once daily inhaled dose 5 of AZD8630. |
| Part A: SAD (Placebo) | PLACEBO_COMPARATOR | Healthy participants and healthy participants of Chinese and Japanese ethnicity will receive single inhaled doses of placebo. |
| Part A: MAD (Placebo) | PLACEBO_COMPARATOR | Healthy participants and healthy participants of Chinese and Japanese ethnicity will receive once daily inhaled dose of placebo. |
| Part B (AZD8630) | EXPERIMENTAL | Participants with asthma will be randomized to one of 3 inhaled dose levels 3, 6, and 7 of AZD8630 once daily. |
| Part B (Placebo) | PLACEBO_COMPARATOR | Participants with asthma will receive once daily inhaled dose of placebo. |
| Name | Type | Description |
|---|---|---|
| AZD8630 | DRUG | The drug will be administered by inhalation |
| Placebo | DRUG | The placebo will be administered by inhalation |
| Inhaler | DEVICE | The drug/placebo will be administered by inhalation using the inhaler |
| Dry powder inhaler | DEVICE | Single inhaled dose of AZD8630 via dry powder inhaler. |
| Saphira device | DEVICE | AZD8630 or placebo will be administered to participants via Saphira device. |
Principal inclusion criteria (abbreviated): 1. Patient must be 18 to 80 years of age inclusive 2. Documented physician diagnosis of asthma for at least 12 months, with objective evidence of asthma (spirometric, bronchial challenge, exercise challenge or therapeutic response) within the last 5 years...