Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
AZD6793 · 2 trials · 2 indications
The annualised moderate or severe COPD exacerbation rate (based on exacerbations reported by the investigator) up to 24 Weeks treatment period compared to placebo
Safety and tolerability of AZD6793 following oral administration of SAD in healthy participants.
Safety and tolerability of AZD6793 following oral administration of MAD in healthy participants.
Safety and tolerability of AZD6793 following oral administration of SAD in healthy participants.
Safety and tolerability of AZD6793 following oral administration of MAD in healthy participants.
Safety and tolerability of AZD6793 following oral administration of SAD in healthy participants.
Safety and tolerability of AZD6793 following oral administration of MAD in healthy participants.
Safety and tolerability of AZD6793 following oral administration of SAD in healthy participants.
Safety and tolerability of AZD6793 following oral administration of MAD in healthy participants.
Safety and tolerability of AZD6793 following oral administration of SAD in healthy participants.
Safety and tolerability of AZD6793 following oral administration of MAD in healthy participants.
Safety and tolerability of AZD6793 following oral administration of SAD in healthy participants.
Safety and tolerability of AZD6793 following oral administration of MAD in healthy participants.
Safety and tolerability of AZD6793 following oral administration of SAD in healthy participants.
Safety and tolerability of AZD6793 following oral administration of MAD in healthy participants.
Evaluating the relative oral bioavailability between the test formulation and the reference formulation after a single oral dose of AZD6793 in healthy participants.
Evaluating the relative oral bioavailability between the test formulation and the reference formulation after a single oral dose of AZD6793 in healthy participants.
Investigating the effect of a high fat high calorie (HFHC) meal compared to fasting conditions, on the PK of AZD6793 after a single oral dose in healthy participants.
Investigating the effect of a high fat high calorie (HFHC) meal compared to fasting conditions, on the PK of AZD6793 after a single oral dose in healthy participants.
Safety and tolerability of AZD6793 following oral administration repeated up to 28 days (at least 26 days) in COPD participants.
Safety and tolerability of AZD6793 following oral administration repeated up to 28 days (at least 26 days) in COPD participants.
Safety and tolerability of AZD6793 following oral administration repeated up to 28 days (at least 26 days) in COPD participants.
Safety and tolerability of AZD6793 following oral administration repeated up to 28 days (at least 26 days) in COPD participants.
Safety and tolerability of AZD6793 following oral administration repeated up to 28 days (at least 26 days) in COPD participants.
| Arm | Type | Description |
|---|---|---|
| Dose 1 of AZD6793 | EXPERIMENTAL | Approximately 290 participants will be randomized to receive Dose 1 of AZD6793 |
| Dose 2 of AZD6793 | EXPERIMENTAL | Approximately 290 participants will be randomized to receive Dose 2 of AZD6793 |
| Matching Placebo | PLACEBO_COMPARATOR | Approximately 290 participants will be randomized to receive Matching Placebo |
| Part 1 (SAD): Cohort 1 | EXPERIMENTAL | 6 Healthy participants will receive a single oral dose A of AZD6793 and 2 healthy participants will receive placebo |
| Part 1 (SAD): Cohort 2 | EXPERIMENTAL | 6 Healthy participants will receive a single oral dose B of AZD6793 and 2 healthy participants will receive placebo |
| Part 1 (SAD): Cohort 3 | EXPERIMENTAL | 6 Healthy participants will receive a single oral dose C of AZD6793 and 2 healthy participants will receive placebo |
| Part 1 (SAD): Cohort 4 | EXPERIMENTAL | 6 Healthy participants will receive a single oral dose D of AZD6793 and 2 healthy participants will receive placebo |
| Part 1 (SAD): Cohort 5 | EXPERIMENTAL | 6 Healthy participants will receive a single oral dose E of AZD6793 and 2 healthy participants will receive placebo |
| Part 2 (MAD): Cohort 1 | EXPERIMENTAL | 6 Healthy participants will receive dose W of AZD6793 and 2 healthy participants will receive placebo once daily on Day 1 and 8 and twice daily on Day 3 to Day 7 |
| Part 2 (MAD): Cohort 2 | EXPERIMENTAL | 6 Healthy participants will receive dose X of AZD6793 and 2 healthy participants will receive placebo once daily on Day 1 and 8 and twice daily on Day 3 to Day 7 |
| Part 2 (MAD): Cohort 3 | EXPERIMENTAL | 6 Healthy participants will receive dose Y of AZD6793 and 2 healthy participants will receive placebo once daily on Day 1 and 8 and twice daily on Day 3 to Day 7 |
| Part 2 (MAD) : Cohort 4 | EXPERIMENTAL | 6 Healthy participants will receive dose Z of AZD6793 and 2 healthy participants will receive placebo once daily on Day 1 and 8 and twice daily on Day 3 to Day 7 |
| Part 3: Treatment sequence 1 | EXPERIMENTAL | Participants will receive a single oral dose of test formulation AZD6793 in fasted state, test formulation AZD6793 in fed state following reference formulation AZD6793 in fasted state once on Day 1 of each treatment period. |
| Part 3: Treatment sequence 2 | EXPERIMENTAL | Participants will receive a single oral dose of test formulation AZD6793 in fed state, reference formulation AZD6793 in fasted state following test formulation AZD6793 in fasted state once on Day 1 of each treatment period. |
| Part 3: Treatment sequence 3 | EXPERIMENTAL | Participants will receive a single oral dose of reference formulation AZD6793 in fasted state, test formulation AZD6793 in fasted state following test formulation AZD6793 in fed state once on Day 1 of each treatment period. |
| Part 4 (COPD): Cohort 1 | EXPERIMENTAL | 10 participants with COPD will receive AZD6793 once daily and 5 participants with COPD will receive placebo |
| Name | Type | Description |
|---|---|---|
| AZD6793 | DRUG | Oral dosage |
| Placebo | OTHER | Oral dosage |
Inclusion Criteria: * Participant must be ≥40 years of age at the time of signing the informed consent. * Documented primary diagnosis of COPD for at least 12 months prior to enrolment. * Pre-BD FEV1/FVC \< 0.7 at Visit 1 and pre- and post-BD FEV1/FVC \< 0.7, and post-BD FEV1 ≥ 25% to \< 80% of pre...
AZD6793 is being developed for the treatment of chronic obstructive pulmonary disease (COPD) and other inflammatory diseases. It is an investigational small molecule that is currently in Phase 2 clinical development. AstraZeneca PLC is the developer.
AZD6793 is being developed by AstraZeneca PLC, a biopharmaceutical company listed on the Nasdaq under the ticker symbol AZN. AstraZeneca is responsible for the clinical development program of AZD6793.
AZD6793 is in Phase 2 clinical development. A Phase 2 trial in participants with moderate to very severe chronic obstructive pulmonary disease (COPD) is currently recruiting. A Phase 1 study in healthy volunteers and COPD participants has been completed.
AZD6793 has been studied in two clinical trials. The Phase 2 trial NCT07082738 is evaluating AZD6793 in participants with moderate to very severe COPD and is currently recruiting. The completed Phase 1 trial NCT05662033 assessed safety, tolerability, and pharmacokinetics in healthy volunteers and COPD participants.
No, AZD6793 is not approved by the FDA. It is an investigational drug that is still in clinical development, currently in Phase 2 testing for chronic obstructive pulmonary disease (COPD) and other inflammatory diseases.