Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
AZD4604 for via DPI · 1 trial · 1 indication
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...
AZD4604 is an investigational small molecule being developed for the treatment of asthma. It is administered via dry powder inhalation (DPI). The drug is currently in Phase 1 clinical development and is not yet approved for use.
AZD4604 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 drug's safety and efficacy in patients with asthma.
AZD4604 is in Phase 1 clinical development. A Phase 1 trial has been completed, which involved healthy volunteers and patients with mild asthma. The drug is still investigational and has not received regulatory approval.
AZD4604 has one completed clinical trial registered under NCT04769869. This Phase 1 study enrolled 110 participants, including healthy volunteers and patients with mild asthma, and was conducted in the United Kingdom. The trial was placebo-controlled and randomized.
AZD4604 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development for the treatment of asthma. The drug has not yet completed the clinical trials and regulatory review process required for approval.