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AZD6793

Phase 1

Inflammatory Diseases | Small molecule | Other |AstraZeneca PLC|Last Updated: Oct 29, 2025

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedCONTROLLEDBiomarker
Total Trials1
Total Enrollment93
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05662033A Study to Investigate the Safety, Tolerability, and Pharmacokinetics (PK) of Oral AZD6793 in Healthy and Chronic Obstructive Pulmonary Disease Participants, to Assess the Relative Oral Bioavailability Between Two Formulations, and the Food Effect on the PK of AZD6793 Compared to Fasting State.PHASE1 COMPLETED 93 — — Dec 5, 2022Oct 29, 2024Oct 29, 20252 United Kingdom
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Study Endpoints
Primary Endpoints
Part 1 (SAD): Number of participants with adverse events
From screening up to Follow up visit (Day 6±1)

Safety and tolerability of AZD6793 following oral administration of SAD in healthy participants.

Part 2 (MAD): Number of participants with adverse events
From screening up to Follow up visit (Day 14±1)

Safety and tolerability of AZD6793 following oral administration of MAD in healthy participants.

Part 1 (SAD): Number of participants with abnormal findings in vital signs (supine Blood Pressure (BP), pulse, respiratory rate, peripheral oxygen saturation (SpO2) and oral body temperature)
From screening, Treatment Day 1 to Day 4 up to Follow up visit (Day 6±1)

Safety and tolerability of AZD6793 following oral administration of SAD in healthy participants.

Part 2 (MAD): Number of participants with abnormal findings in vital signs (supine Blood Pressure (BP), pulse, respiratory rate, peripheral oxygen saturation (SpO2) and oral body temperature)
From screening, Treatment Day -1 to Day 10 up to Follow up visit (Day 14±1)

Safety and tolerability of AZD6793 following oral administration of MAD in healthy participants.

Part 1 (SAD): Number of participants with abnormal findings in 12 Lead electrocardiogram (ECG)
From screening, Treatment Day -1 to Day 4 up to Follow up visit (Day 6±1)

Safety and tolerability of AZD6793 following oral administration of SAD in healthy participants.

Part 2 (MAD): Number of participants with abnormal findings in 12 Lead electrocardiogram (ECG)
From screening, Treatment Day -1 to Day 10 up to Follow up visit (Day 14±1)

Safety and tolerability of AZD6793 following oral administration of MAD in healthy participants.

Part 1 (SAD): Number of participants with abnormal findings in 12 Lead Digital electrocardiogram (dECG)
Day 1 to Day 3

Safety and tolerability of AZD6793 following oral administration of SAD in healthy participants.

Part 2 (MAD): Number of participants with abnormal findings in 12 Lead Digital electrocardiogram (dECG)
Day 1 to Day 3, Day 5, Day 8 to Day 10

Safety and tolerability of AZD6793 following oral administration of MAD in healthy participants.

Part 1 (SAD): Number of participants with abnormal findings in Telemetry
Day -1 to Day 3

Safety and tolerability of AZD6793 following oral administration of SAD in healthy participants.

Part 2 (MAD): Number of participants with abnormal findings in Telemetry
Day -1 to Day 2 and Day 8 to Day 10

Safety and tolerability of AZD6793 following oral administration of MAD in healthy participants.

Part 1 (SAD): Number of participants with abnormal findings in Physical examinations
From screening, Treatment Day -1 to 4 and follow up visit

Safety and tolerability of AZD6793 following oral administration of SAD in healthy participants.

Part 2 (MAD): Number of participants with abnormal findings in Physical examinations
From screening, Treatment Day -1 to 10 and follow up visit

Safety and tolerability of AZD6793 following oral administration of MAD in healthy participants.

Part 1 (SAD): Number of participants with abnormal findings in Laboratory assessments (haematology, serum clinical chemistry, and urinalysis)
From screening, Treatment Day -1, Day 2, Day 4 and Follow up visit (Day 6±1)

Safety and tolerability of AZD6793 following oral administration of SAD in healthy participants.

Part 2 (MAD): Number of participants with abnormal findings in Laboratory assessments (haematology, serum clinical chemistry, and urinalysis)
From screening, Treatment Day -1 to Day 10 up to Follow up visit (Day 14±1)

Safety and tolerability of AZD6793 following oral administration of MAD in healthy participants.

Part 3 (Bioavailability): Maximum observed plasma (peak) drug concentration [Cmax]
Day 1 to Day 3

Evaluating the relative oral bioavailability between the test formulation and the reference formulation after a single oral dose of AZD6793 in healthy participants.

Part 3 (Bioavailability): Area under plasma concentration-time curve from zero to infinity [AUCinf]
Day 1 to Day 3

Evaluating the relative oral bioavailability between the test formulation and the reference formulation after a single oral dose of AZD6793 in healthy participants.

Part 3 (Food effect): Cmax of AZD6793
Day 1 to Day 3

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.

Part 3 (Food effect): AUCinf of AZD6793
Day 1 to Day 3

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.

Part 4 (COPD): Number of participants with adverse events
From screening up to Follow up visit (Day 34±2)

Safety and tolerability of AZD6793 following oral administration repeated up to 28 days (at least 26 days) in COPD participants.

Part 4 (COPD): Number of participants with abnormal findings in vital signs (supine Blood Pressure (BP), pulse, respiratory rate, peripheral oxygen saturation (SpO2) and oral body temperature)
From screening up to Follow up visit (Day 34±2)

Safety and tolerability of AZD6793 following oral administration repeated up to 28 days (at least 26 days) in COPD participants.

Part 4 (COPD): Number of participants with abnormal findings in 12 Lead electrocardiogram (ECG)
From screening up to Follow up visit (Day 34±2)

Safety and tolerability of AZD6793 following oral administration repeated up to 28 days (at least 26 days) in COPD participants.

Part 4 (COPD): Number of participants with abnormal findings in Physical examinations
From screening, Treatment Day -1, 1, 14, 28 and follow up visit (34±2)

Safety and tolerability of AZD6793 following oral administration repeated up to 28 days (at least 26 days) in COPD participants.

Part 4 (COPD): Number of participants with abnormal findings in Laboratory assessments (haematology, clinical chemistry, coagulation tests, and urinalysis)
From screening up to Follow up visit (Day 34±2)

Safety and tolerability of AZD6793 following oral administration repeated up to 28 days (at least 26 days) in COPD participants.

Secondary Endpoints
Part 1 (SAD): Maximum observed plasma (peak) drug concentration (Cmax)
Day 1 to Day 3
Part 1 (SAD): Time to reach peak or maximum observed concentration or response following drug administration (tmax)
Day 1 to Day 3
Part 1 (SAD): Terminal rate constant, estimated by log linear least squares regression of the terminal part of the concentration time curve (λz)
Day 1 to Day 3
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Study Design & Arms
AllocationRANDOMIZED
MaskingSINGLE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Part 1 (SAD): Cohort 1EXPERIMENTAL6 Healthy participants will receive a single oral dose A of AZD6793 and 2 healthy participants will receive placebo
Part 1 (SAD): Cohort 2EXPERIMENTAL6 Healthy participants will receive a single oral dose B of AZD6793 and 2 healthy participants will receive placebo
Part 1 (SAD): Cohort 3EXPERIMENTAL6 Healthy participants will receive a single oral dose C of AZD6793 and 2 healthy participants will receive placebo
Part 1 (SAD): Cohort 4EXPERIMENTAL6 Healthy participants will receive a single oral dose D of AZD6793 and 2 healthy participants will receive placebo
Part 1 (SAD): Cohort 5EXPERIMENTAL6 Healthy participants will receive a single oral dose E of AZD6793 and 2 healthy participants will receive placebo
Part 2 (MAD): Cohort 1EXPERIMENTAL6 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 2EXPERIMENTAL6 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 3EXPERIMENTAL6 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 4EXPERIMENTAL6 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 1EXPERIMENTALParticipants 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 2EXPERIMENTALParticipants 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 3EXPERIMENTALParticipants 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 1EXPERIMENTAL10 participants with COPD will receive AZD6793 once daily and 5 participants with COPD will receive placebo
Interventions
NameTypeDescription
AZD6793DRUGAZD6793 will be administered orally
PlaceboDRUGPlacebo will be administered orally
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Eligibility Criteria
Age Range18 Years — 80 Years
SexALL
Healthy VolunteersYes
Study Sites2

Main Inclusion Criteria: Parts 1,2 and 3: * Healthy male or female participants aged 18 to 55 years with suitable veins for cannulation or repeated venepuncture * Females must have a negative pregnancy test must not be lactating and must be either (a) non-childbearing potential, confirmed by post-...

Countries:United Kingdom
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