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Also known as AZD8965 low dose
AZD8965 · 1 trial · 1 indication
To assess the safety and tolerability of AZD8965 following oral administration of single ascending doses to healthy participants.
To assess the safety and tolerability of AZD8965 following oral administration of multiple ascending doses to healthy participants.
To assess the effect of a high fat meal compared to fasting conditions on the PK of active drug and pro-drug following oral administration of AZD8965 in healthy participants.
To assess the effect of a high fat meal compared to fasting conditions on the PK of active drug and pro-drug following oral administration of AZD8965 in healthy participants.
To assess the effect of a high fat meal compared to fasting conditions on the PK of active drug and pro-drug following oral administration of AZD8965 in healthy participants.
To assess the effect of a high fat meal compared to fasting conditions on the PK of active drug and pro-drug following oral administration of AZD8965 in healthy participants.
To assess the effect of a high fat meal compared to fasting conditions on the PK of active drug and pro-drug following oral administration of AZD8965 in healthy participants.
To assess the effect of a high fat meal compared to fasting conditions on the PK of active drug and pro-drug following oral administration of AZD8965 in healthy participants.
To assess the effect of a high fat meal compared to fasting conditions on the PK of active drug and pro-drug following oral administration of AZD8965 in healthy participants.
To assess the effect of a high fat meal compared to fasting conditions on the PK of active drug and pro-drug following oral administration of AZD8965 in healthy participants.
To assess the effect of a high fat meal compared to fasting conditions on the PK of active drug and pro-drug following oral administration of AZD8965 in healthy participants.
To assess the effect of a high fat meal compared to fasting conditions on the PK of active drug and pro-drug following oral administration of AZD8965 in healthy participants.
To assess the effect of a high fat meal compared to fasting conditions on the PK of active drug and pro-drug following oral administration of AZD8965 in healthy participants.
To assess the effect of a high fat meal compared to fasting conditions on the PK of active drug and pro-drug following oral administration of AZD8965 in healthy participants.
To assess the effect of a high fat meal compared to fasting conditions on the PK of active drug and pro-drug following oral administration of AZD8965 in healthy participants.
To assess the effect of a high fat meal compared to fasting conditions on the PK of active drug and pro-drug following oral administration of AZD8965 in healthy participants.
To assess the effect of a high fat meal compared to fasting conditions on the PK of active drug and pro-drug following oral administration of AZD8965 in healthy participants.
To assess the effect of a high fat meal compared to fasting conditions on the PK of active drug and pro-drug following oral administration of AZD8965 in healthy participants.
| Arm | Type | Description |
|---|---|---|
| Part 1: SAD Cohort 1 - AZD8965 (Dose 1) | EXPERIMENTAL | Participants will receive a single dose of AZD8965 (Dose 1) or matching placebo to AZD8965 on Day 1. |
| Part 1: SAD Cohort 2 - AZD8965 (Dose 2) | EXPERIMENTAL | Participants will receive a single dose of AZD8965 (Dose 2) or matching placebo to AZD8965 on Day 1. |
| Part 1: SAD Cohort 3 - AZD8965 (Dose 3) | EXPERIMENTAL | Participants will receive a single dose of AZD8965 (Dose 3) or matching placebo to AZD8965 on Day 1. |
| Part 1: SAD Cohort 4 - AZD8965 (Dose 4) | EXPERIMENTAL | Participants will receive a single dose of AZD8965 (Dose 4) or matching placebo to AZD8965 on Day 1. |
| Part 1: SAD Cohort 5 - AZD8965 (Dose 5) | EXPERIMENTAL | Participants will receive a single dose of AZD8965 (Dose 5) or matching placebo to AZD8965 on Day 1. |
| Part 2: MAD Cohort 1 - AZD8965 (Dose 1) | EXPERIMENTAL | Participants will receive multiple doses of AZD8965 (Dose 1) or matching placebo to AZD8965 from Day 1 to Day 8. |
| Part 2: MAD Cohort 2 - AZD8965 (Dose 2) | EXPERIMENTAL | Participants will receive multiple doses of AZD8965 (Dose 2) or matching placebo to AZD8965 from Day 1 to Day 8. |
| Part 2: MAD Cohort 3 - AZD8965 (Dose 3) | EXPERIMENTAL | Participants will receive multiple doses of AZD8965 (Dose 3) or matching placebo to AZD8965 from Day 1 to Day 8. |
| Part 3A: SAD Cohort 1 (Japanese) - AZD8965 (Dose 1) | EXPERIMENTAL | Japanese participants will receive a single dose of AZD8965 (Dose 1) or matching placebo to AZD8965 on Day 1. |
| Part 3A: SAD Cohort 2 (Japanese) - AZD8965 (Dose 2) | EXPERIMENTAL | Japanese participants will receive a single dose of AZD8965 (Dose 2) or matching placebo to AZD8965 on Day 1. |
| Part 3A: SAD Cohort 3 (Chinese) - AZD8965 (Dose 1) | EXPERIMENTAL | Chinese participants will receive a single dose of AZD8965 (Dose 1) or matching placebo to AZD8965 on Day 1. |
| Part 3B: Single and multiple ascending dose (SMAD) Cohort 1 (Japanese) - AZD8965 (Dose 1) | EXPERIMENTAL | Japanese participants will receive a single dose of AZD8965 (Dose 1) or matching placebo to AZD8965 on Day 1, followed by multiple doses of AZD8965 or matching placebo from Day 3 until Day 9. |
| Part 3B: SMAD Cohort 2 (Chinese) - AZD8965 (Dose 1) | EXPERIMENTAL | Chinese participants will receive a single dose of AZD8965 (Dose 1) or matching placebo to AZD8965 on Day 1, followed by multiple doses of AZD8965 or matching placebo from Day 3 until Day 9. |
| Part 4: Food Effect Cohort - AZD8965 | EXPERIMENTAL | Participants will receive 2 single dose treatments of AZD8965 \[following an overnight fast of at least 10 hours in a fasted state or a fed state (after a high fat meal)\]. |
| Name | Type | Description |
|---|---|---|
| AZD8965 | DRUG | AZD8965 will be administered orally. |
| Placebo | OTHER | Placebo will be administered orally. |
Inclusion Criteria: * Healthy male and female participants (including Japanese and Chinese participants) with suitable veins for cannulation or repeated venipuncture. * All females of childbearing potential must have a negative pregnancy test at the Screening Visit (serum) and on admission (urine) ...
AZD8965 is an investigational small molecule being developed for idiopathic pulmonary fibrosis (IPF) and is also studied in healthy participants. It is currently in Phase 1 clinical development, with a Phase 2b trial recruiting participants with IPF.
AZD8965 is being developed by AstraZeneca PLC, a biopharmaceutical company listed on the stock exchange under the ticker AZN.
AZD8965 is in Phase 1 clinical development. A Phase 1 study in healthy participants has been completed, and a Phase 2b trial in participants with idiopathic pulmonary fibrosis is currently recruiting.
AZD8965 has one completed Phase 1 trial (NCT06502379) in healthy participants, including Japanese and Chinese participants, and one recruiting Phase 2b trial (NCT07652658) in participants with IPF.
Yes, AZD8965 is also known as AZD8965 low dose. Both names refer to the same investigational drug being developed by AstraZeneca.
AZD8965 is not FDA approved. It is an investigational drug currently in clinical development, with a completed Phase 1 study and an ongoing Phase 2b trial in idiopathic pulmonary fibrosis.