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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04769869 | A Clinical Trial in Healthy Volunteers and Patients With Mild Asthma to Investigate a New Medicine (AZD4604) for the Treatment of Asthma | PHASE1 | COMPLETED | 110 | — | — | Jul 8, 2022 | Jan 24, 2023 | Mar 20, 2023 | 3 | United Kingdom |
Safety and tolerability of AZD4604 following inhaled administration of single ascending doses to healthy volunteers.
Safety and tolerability of AZD4604 following inhaled administration of multiple ascending doses to healthy volunteers.
Cmax of AZD4604 following IV and PO administration of a single dose to healthy volunteers.
tmax of AZD4604 following IV and PO administration of a single dose to healthy volunteers.
λz of AZD4604 following IV and PO administration of a single dose to healthy volunteers.
t1/2λz of AZD4604 following IV and PO administration of a single dose to healthy volunteers.
AUC (0 - 12) of AZD4604 following IV and PO administration of a single dose to healthy volunteers.
AUC (0 - 24) of AZD4604 following IV and PO administration of a single dose to healthy volunteers.
AUClast of AZD4604 following IV and PO administration of a single dose to healthy volunteers.
AUClast of AZD4604 following PO administration of a single dose to healthy volunteers.
CL of AZD4604 following IV administration of a single dose to healthy volunteers.
Vz/F of AZD4604 following PO administration of a single dose to healthy volunteers.
Vz of AZD4604 following IV administration of a single dose to healthy volunteers.
AUClast/D of AZD4604 following IV and PO administration of a single dose to healthy volunteers.
AUCinf of AZD4604 following IV and PO administration of a single dose to healthy volunteers.
AUCinf/D of AZD4604 following IV and PO administration of a single dose to healthy volunteers.
Cmax/D of AZD4604 following IV and PO administration of a single dose to healthy volunteers.
tlast of AZD4604 following IV and PO administration of a single dose to healthy volunteers.
Safety and tolerability of AZD4604 following inhaled administration of multiple ascending doses to patients.
| Arm | Type | Description |
|---|---|---|
| Part 1a (SAD): AZD4604 for inhalation via DPI (Dose 1) | EXPERIMENTAL | Healthy volunteers will receive a single inhaled dose of AZD4604 Dose 1 administered with a DPI. |
| Part 1a (SAD): AZD4604 for inhalation via DPI (Dose 2) | EXPERIMENTAL | Healthy volunteers will receive a single inhaled dose of AZD4604 Dose 2 administered with a DPI. |
| Part 1a (SAD): AZD4604 for inhalation via DPI(Dose 3) | EXPERIMENTAL | Healthy volunteers will receive a single inhaled dose of AZD4604 Dose 3 administered with a DPI. |
| Part 1a (SAD): AZD4604 for inhalation via DPI (Dose 4) | EXPERIMENTAL | Healthy volunteers will receive a single inhaled dose of AZD4604 Dose 4 administered with a DPI. |
| Part 1a (SAD): AZD4604 for inhalation via DPI (Dose 5) | EXPERIMENTAL | Healthy volunteers will receive a single inhaled dose of AZD4604 Dose 5 administered with a DPI. |
| Part 1a (SAD): AZD4604 for inhalation via DPI (Dose 6) | EXPERIMENTAL | Healthy volunteers will receive a single inhaled dose of AZD4604 Dose 6 administered with a DPI. |
| Part 1a (SAD): AZD4604 for inhalation via DPI (Dose 7) | EXPERIMENTAL | Healthy volunteers will receive a single inhaled dose of AZD4604 Dose 7 administered with a DPI. |
| Part 1a (SAD): AZD4604 for inhalation via DPI | EXPERIMENTAL | An additional cohort of healthy volunteers will receive a single inhaled dose of AZD4604 administered with a DPI. |
| Part 1a (SAD): Placebo for AZD4604 for inhalation via DPI | PLACEBO_COMPARATOR | Healthy volunteers will receive placebo administered with a DPI. |
| Part 1b: AZD4604 for intravenous administration | EXPERIMENTAL | Healthy volunteers will receive a single IV dose of AZD4604 administered as a 20 minute infusion. |
| Part 1b: AZD4604 for oral administration | EXPERIMENTAL | Healthy volunteers will receive a single PO dose of AZD4604. |
| Part 2 (MAD): AZD4604 for inhalation via DPI (Dose 8) | EXPERIMENTAL | Healthy volunteers will receive multiple inhaled dose of AZD4604 administered with a DPI. |
| Part 2 (MAD): AZD4604 for inhalation via DPI (Dose 9) | EXPERIMENTAL | Healthy volunteers will receive multiple inhaled dose of AZD4604 administered with a DPI. |
| Part 2 (MAD): AZD4604 for inhalation via DPI (Dose 10) | EXPERIMENTAL | Healthy volunteers will receive multiple inhaled dose of AZD4604 administered with a DPI. |
| Part 2 (MAD): Placebo for AZD4604 for inhalation via DPI | PLACEBO_COMPARATOR | Healthy volunteers will receive placebo administered with a DPI. |
| Part 3 (MAD): AZD4604 for inhalation via DPI (Dose 9) | EXPERIMENTAL | Patients will receive multiple inhaled dose of AZD4604 administered with a DPI. |
| Part 3 (MAD): AZD4604 for inhalation via DPI (Dose 10) | EXPERIMENTAL | Patients will receive multiple inhaled dose of AZD4604 administered with a DPI. |
| Part 3 (MAD): Placebo for AZD4604 for inhalation via DPI | PLACEBO_COMPARATOR | Patients will receive placebo administered with a DPI. |
| Part 3 (PoM): AZD4604 for inhalation via DPI (Dose 9 or Dose 10) | EXPERIMENTAL | Patients will receive multiple inhaled dose of AZD4604 administered with a DPI. |
| Name | Type | Description |
|---|---|---|
| AZD4604 for inhalation via DPI | DRUG | Healthy volunteers will receive AZD4604 administered with a DPI. The dose is expected to be administered between 10 to 45 minutes, depending upon dose. The dose will be administered after an overnight fast of at least 10 hours. Healthy volunteers will be allowed to drink water to prevent dehydration until 1 hour before dosing. |
| Placebo for AZD4604 for inhalation via DPI | DRUG | Part 1a: An additional cohort of healthy volunteers will receive a placebo administered with a DPI. Part 2: Healthy volunteers will receive placebo administered with a DPI. They will receive BID doses on Day 1 to Day 6, and a single dose will be administered on Day 7. Part 3: Patients will receive placebo administered with a DPI. They will receive BID doses on Day 1 to Day 9, and a single dose will be administered on Day 10. |
| AZD4604 for IV administration | DRUG | Healthy volunteers will receive a single IV dose of AZD4604 administered over 20 minutes. The dose will be administered after an overnight fast of at least 10 hours. Healthy volunteers will be allowed to drink water to prevent dehydration until 1 hour before dosing. |
| AZD4604 for oral administration | DRUG | Healthy volunteers will receive a single PO dose of AZD4604. The dose will be administered after an overnight fast of at least 10 hours. Healthy volunteers will be allowed to drink water to prevent dehydration until 1 hour before dosing. |
Inclusion criteria: All Study Parts: * Provision of signed and dated, written informed consent prior to any study specific procedures. * Female subjects must have a negative pregnancy test at the Screening Visit and on admission to the Study Center or prior to randomization for Part 3 (Day -1 or D...