Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
AZD0449 · 1 trial · 1 indication
Safety and tolerability of AZD0449 following inhaled administration of single ascending doses to healthy participants, inhaled nebulized administration of multiple ascending doses to healthy participants and patients with mild asthma, and repeated inhaled administration to patients with mild asthma using a DPI was assessed.
Cmax of AZD0449 following intravenous administration of a single dose to healthy participants was assessed.
AUCinf of AZD0449 following intravenous administration of a single dose to healthy participants was assessed.
AUClast of AZD0449 following intravenous administration of a single dose to healthy participants was assessed.
AUC (0-24) of AZD0449 following intravenous administration of a single dose to healthy participants was assessed.
tmax of AZD0449 following intravenous administration of a single dose to healthy participants was assessed.
t½λz of AZD0449 following intravenous administration of a single dose to healthy participants was assessed.
CL of AZD0449 following intravenous administration of a single dose of AZD0449 to healthy volunteers was assessed.
Vz of AZD0449 following intravenous administration of a single dose of AZD0449 to healthy volunteers was assessed.
λz of AZD0449 following intravenous administration of a single dose to healthy participants was assessed.
tlast of AZD0449 following intravenous administration of a single dose to healthy participants was assessed.
Cmax/D of AZD0449 following intravenous administration of a single dose to healthy participants was assessed.
| Arm | Type | Description |
|---|---|---|
| Part 1a (SAD) Cohort 1 | EXPERIMENTAL | 6 participants will receive inhaled dose 1 of AZD0449 nebulized suspension and 2 participants will receive inhaled placebo. |
| Part 1a (SAD) Cohort 2 | EXPERIMENTAL | 6 participants will receive inhaled dose 2 of AZD0449 nebulized suspension and 2 participants will receive inhaled placebo. |
| Part 1a (SAD) Cohort 3 | EXPERIMENTAL | 6 participants will receive inhaled dose 3 of AZD0449 nebulized suspension and 2 participants will receive inhaled placebo. |
| Part 1a (SAD) Cohort 4 | EXPERIMENTAL | 6 participants will receive inhaled dose 4 of AZD0449 nebulized suspension and 2 participants will receive inhaled placebo. |
| Part 1a (SAD) Cohort 5 | PLACEBO_COMPARATOR | 6 participants will receive inhaled dose 5 of AZD0449 nebulized suspension and 2 participants will receive inhaled placebo. |
| Part 1a (SAD) Cohort 6 | EXPERIMENTAL | 6 participants will receive inhaled dose 6 of AZD0449 nebulized suspension and 2 participants will receive inhaled placebo. |
| Part 1b (IV cohort 1) | EXPERIMENTAL | All 6 participants will receive single IV dose of AZD0449 solution. |
| Part 2a (MAD) Cohort 1 | EXPERIMENTAL | 6 participants will receive inhaled dose 7 of AZD0449 nebulized suspension and 3 participants will receive inhaled placebo. |
| Part 2a (MAD) Cohort 2 | EXPERIMENTAL | 6 participants will receive inhaled dose 8 of AZD0449 nebulized suspension and 3 participants will receive inhaled placebo. |
| Part 2b (MAD/healthy volunteers) Cohort 3 | EXPERIMENTAL | 18 healthy volunteers will receive inhaled dose 9 of AZD0449 nebulized suspension and 12 healthy volunteers will receive inhaled placebo. |
| Part 3a (DPI/PoM) | EXPERIMENTAL | 18 participants will receive inhaled dose 10 of AZD0449 DPI and 6 participants will receive inhaled placebo. |
| Part 1b (IV cohort 2) | EXPERIMENTAL | 6 healthy volunteers will receive single IV dose of AZD0449 solution. |
| Part 3b (DPI/healthy volunteers) | EXPERIMENTAL | Part 3b is optional. 8 healthy volunteers; 6 volunteers will receive AZD0449 DPI and 2 volunteers will recieve placebo. |
| Name | Type | Description |
|---|---|---|
| AZD0449 | DRUG | Participants will receive single inhaled AZD0449 nebulizer suspension and single IV dose of AZD0449 solution. |
| Placebo | DRUG | Participants will receive single dose of placebo for AZD0449 (nebulizer suspension). |
Inclusion criteria: Part 1a/b: 1. Provision of signed and dated, written informed consent before any study specific procedures (applicable for all parts). 2. Healthy male volunteers and healthy female volunteers (for Part 1a and Part 1b first IV cohort, female volunteers must be of non-childbearing...
AZD0449 is an investigational small molecule being developed for the treatment of asthma. It is administered via inhalation and is currently in Phase 1 clinical development. The drug has been studied in healthy volunteers and patients with mild asthma to evaluate its safety and anti-inflammatory effects.
AZD0449 is a small molecule designed to have anti-inflammatory effects in the lungs. It is administered by inhalation for the treatment of asthma. The specific molecular target of AZD0449 has not been disclosed in the available information.
AZD0449 is being developed by AstraZeneca PLC, a biopharmaceutical company listed on the stock exchange under the ticker symbol AZN. The drug is currently in Phase 1 clinical development for the treatment of asthma.
AZD0449 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. A Phase 1 study has been completed, evaluating the safety and anti-inflammatory effects of inhaled AZD0449 in healthy volunteers and patients with mild asthma.
AZD0449 has been studied in one clinical trial, identified as NCT03766399. This Phase 1 study, titled 'A Study in Healthy Volunteers and Patients With Mild Asthma to Investigate the Safety, Anti-inflammatory Effect of Inhaled AZD0449', has been completed. The trial enrolled 131 participants in Germany, New Zealand, and the United Kingdom.
AZD0449 is the primary name for this investigational drug. No alternative names have been associated with AZD0449 in the available information. It is a distinct small molecule being developed by AstraZeneca for the treatment of asthma.