Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
AZD8630 · 4 trials · 1 indication
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...
AZD8630 is an investigational small molecule being developed for the treatment of asthma. It is administered via inhalation and is being studied in adults and adolescents with asthma, including those with uncontrolled asthma at risk of exacerbations.
AZD8630 is being developed by AstraZeneca PLC, a biopharmaceutical company listed on the stock exchange under the ticker symbol AZN. The company is conducting clinical trials to evaluate the safety, tolerability, and efficacy of this investigational drug in patients with asthma.
AZD8630 is currently in Phase 2 clinical development for asthma. A Phase 2 dose range-finding study has been completed, and the drug remains investigational, meaning it has not yet been approved by regulatory authorities. Earlier Phase 1 studies have also been completed.
AZD8630 has been studied in four completed clinical trials. These include NCT05110976, a Phase 1 study in healthy subjects and asthma patients; NCT06529419, a Phase 2 dose range-finding study in adults with uncontrolled asthma; NCT06795906, a Phase 1 safety and pharmacokinetic study; and NCT07065331, a Phase 1 study in adolescents with asthma.
AZD8630 is the sole name provided for this investigational drug. No alternative names have been reported in the clinical trial information. It is a distinct small molecule being developed by AstraZeneca for asthma.