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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03766399 | A Study in Healthy Volunteers and Patients With Mild Asthma to Investigate the Safety, Anti-inflammatory Effect of Inhaled AZD0449 | PHASE1 | COMPLETED | 131 | — | — | Nov 30, 2018 | Jun 24, 2021 | Aug 23, 2024 | 4 | Germany, New Zealand +1 |
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...