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AZD4144

Phase 2

Sepsis | Small molecule | Infectious Disease |AstraZeneca PLC|Last Updated: Jul 6, 2026

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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment124
FDA Designations
No designations recorded
Clinical trial landscape

AZD4144 · 7 trials · 8 indications

Phase 2 1Phase 1 6
NCT07215702A Study to Investigate the Efficacy, Safety, and Tolerability of AZD4144in Participants With Sepsis-associated Acute Kidney Injury.Sepsis
RECRUITING124 Analytics
PHASE2RECRUITING
A Study to Investigate the Efficacy, Safety, and Tolerability of AZD4144in Participants With Sepsis-associated Acute Kidney Injury.
Sepsis
NCT07215702124
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Study Endpoints
Primary Endpoints
Area Under the Curve (AUC) of 24-hour Creatinine Clearance (CrCl).
During the treatment period.

The total area under the curve for 24-hour creatinine clearance measured throughout the treatment period.

Area under concentration time curve from time 0 to infinity (AUCinf)
Period 1: Day 1 to Day 6; Period 3: Day 10 to Day 16

To assess the effect of itraconazole on the PK (AUCinf) of AZD4144

Area under concentration curve from time 0 to the last quantifiable concentration (AUClast)
Period 1: Day 1 to Day 6; Period 3: Day 10 to Day 16

To assess the effect of itraconazole on the PK (AUClast) of AZD4144

Maximum observed drug concentration (Cmax)
Period 1: Day 1 to Day 6; Period 3: Day 10 to Day 16

To assess the effect of itraconazole on the PK (Cmax) of AZD4144

Area under concentration-time curve from time 0 to infinity (AUCinf) of AZD4144
Days 1-4, Days 8-11 and Days 15-18

1. To determine the relative bioavailability and compare the plasma exposure of AZD4144 in tablet formulation versus oral solution. 2. To investigate the effect of a high-fat, high-calorie meal, in comparison to fasting conditions, on the PK of AZD4144 (dose 1 and dose 2) after a single oral tablet dose in healthy participants. 3. To assess the effect of the proton pump inhibitor omeprazole on the PK of AZD4144 (dose 2) after a single dose.

Area under concentration-curve from time 0 to the last quantifiable concentration (AUClast) of AZD4144
Days 1-4, Days 8-11 and Days 15-18

1. To determine the relative bioavailability and compare the plasma exposure of AZD4144 in tablet formulation versus oral solution. 2. To investigate the effect of a high-fat, high-calorie meal, in comparison to fasting conditions, on the PK of AZD4144 (dose 1 and dose 2) after a single oral tablet dose in healthy participants. 3. To assess the effect of the proton pump inhibitor omeprazole on the PK of AZD4144 (dose 2) after a single dose.

Maximum observed drug concentration (Cmax) of AZD4144
Days 1-4, Days 8-11 and Days 15-18

1. To determine the relative bioavailability and compare the plasma exposure of AZD4144 in tablet formulation versus oral solution. 2. To investigate the effect of a high-fat, high-calorie meal, in comparison to fasting conditions, on the PK of AZD4144 (dose 1 and dose 2) after a single oral tablet dose in healthy participants. 3. To assess the effect of the proton pump inhibitor omeprazole on the PK of AZD4144 (dose 2) after a single dose.

Number of Participants with Adverse Events (AEs)
From Screening (Day -28 to Day -2) to final follow-up (Day 56)

The safety and tolerability of AZD4144 compared with placebo will be assessed.

Relative change from baseline in systemic interleukin-6 (IL-6) levels
From baseline to 4 weeks

The effect of AZD4144 on circulating inflammatory biomarker IL-6 compared with placebo will be assessed.

Area under plasma concentration-time curve from 0 to infinity (AUCinf)
Day 1 to Day 4 and Day 10 to Day 13

The AUCinf of rosuvastatin when administered alone and in combination with AZD4144 in healthy participants will be evaluated.

Area under the plasma concentration-curve from 0 to the last quantifiable concentration (AUClast)
Day 1 to Day 4 and Day 10 to Day 13

The AUClast of rosuvastatin when administered alone and in combination with AZD4144 in healthy participants will be evaluated.

Maximum plasma drug concentration (Cmax)
Day 1 to Day 4 and Day 10 to Day 13

The Cmax of rosuvastatin when administered alone and in combination with AZD4144 in healthy participants will be evaluated.

Number of participants with adverse events
From first dose (Day 1) until Follow-up (Day 56±1)

The safety and the tolerability of AZD4144 compared with placebo will be evaluated.

Relative change from baseline to 4 weeks in systemic Interleukin-6 (IL-6) levels
Day 1 to Day 28

The effect of AZD4144 on circulating inflammatory biomarker IL-6 compared with placebo will be evaluated.

Observed maximum plasma concentration (Cmax)
From Day 1 to Day 14

To assess the PK of a single oral dose of AZD4144 in participants with severe renal impairment and ESKD compared with healthy control participants.

Area under the plasma concentration-time curve from time zero extrapolated to infinity (AUCinf)
From Day 1 to Day 14

To assess the PK of a single oral dose of AZD4144 in participants with severe renal impairment and ESKD compared with healthy control participants.

Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUClast)
From Day 1 to Day 14

To assess the PK of a single oral dose of AZD4144 in participants with severe renal impairment and ESKD compared with healthy control participants.

Apparent total body clearance (CL/F)
From Day 1 to Day 14

To assess the PK of a single oral dose of AZD4144 in participants with severe renal impairment and ESKD compared with healthy control participants.

Non-renal clearance of drug from plasma (CLNR/F)
From Day 1 to Day 14

To assess the PK of a single oral dose of AZD4144 in participants with severe renal impairment and ESKD compared with healthy control participants.

Apparent volume of distribution based on the terminal phase (Vz/F)
From Day 1 to Day 14

To assess the PK of a single oral dose of AZD4144 in participants with severe renal impairment and ESKD compared with healthy control participants.

Terminal elimination half-life (t½λz)
From Day 1 to Day 14

To assess the PK of a single oral dose of AZD4144 in participants with severe renal impairment and ESKD compared with healthy control participants.

Renal clearance of drug from plasma (CLR)
From Day 1 to Day 4

To assess the PK of a single oral dose of AZD4144 in participants with severe renal impairment and ESKD compared with healthy control participants.

Amount excreted (Ae)
From Day 1 to Day 4

To assess the PK of a single oral dose of AZD4144 in participants with severe renal impairment and ESKD compared with healthy control participants.

Percentage of dose excreted unchanged in urine (fe)
From Day 1 to Day 4

To assess the PK of a single oral dose of AZD4144 in participants with severe renal impairment and ESKD compared with healthy control participants.

Number of Treatment Emergent Adverse Events (TEAEs)
From Day 1 to Follow-up (Day 14/28)

To evaluate the safety and tolerability of AZD4144 single dose in participants with severe renal impairment, ESKD, and their healthy controls.

Secondary Endpoints
Days alive and free of KRT.
Through study completion, an average of 30 days.
Days alive and free of modified KDIGO AKI Stage 2 or 3.
Through study completion, an average of 30 days
AUC: SCr
During the treatment period.
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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Arm 1 (AZD4144)EXPERIMENTALAZD4144 solution for IV infusion
Arm 2 (Placebo)PLACEBO_COMPARATORPlacebo concentrate for solution for infusion
Arm 1: Oral AZD4144EXPERIMENTALIn Period 1, participants will receive a single oral dose of AZD4144 on Day 1. In Period 2, participants will receive itraconazole alone, administered orally, with twice-daily dosing on Day 7 followed by once-daily dosing on Days 8 and 9. In Period 3, participants will receive a single oral dose of AZD4144 on Day 10 in combination with once-daily oral itraconazole till Day 15.
Arm 2: IV Infusion AZD4144EXPERIMENTALIn Period 1, participants will receive a single IV infusion of AZD4144 on Day 1. In Period 2, participants will receive itraconazole alone, administered orally, with twice-daily dosing on Day 7 followed by once-daily dosing on Days 8 and 9. In Period 3, participants will receive a single IV infusion of AZD4144 on Day 10 in combination with once-daily oral itraconazole till Day 15.
Arm 1: AZD4144EXPERIMENTALParticipants will receive single doses of AZD4144 dose 1 as tablet formulation (Treatments A and B) and as an oral solution formulation (Treatment C) under fasted (Treatments A and C) and fed (Treatment B) conditions.
Arm 2: AZD4144 + OmeprazoleEXPERIMENTALParticipants will receive single doses of AZD4144 dose 2 tablet formulation under fasted (Treatment D) and fed (Treatment E) conditions and co-administered with omeprazole (Treatment F).
AZD4144EXPERIMENTALParticipants will receive a single oral dose of AZD4144 under fasted conditions once daily for 28 days.
PlaceboPLACEBO_COMPARATORParticipants will receive a single oral dose of matching placebo to AZD4144 under fasted conditions once daily for 28 days.
Treatment sequence ABEXPERIMENTALParticipants will receive single dose of rosuvastatin under fasted condition (Treatment A), followed by a single dose of rosuvastatin with AZD4144 under fasted condition (Treatment B).
Treatment sequence BAEXPERIMENTALParticipants will receive a single dose of rosuvastatin with AZD4144 under fasted condition (Treatment B), followed by a single dose of rosuvastatin under fasted condition (Treatment A).
Cohort 1: AZD4144EXPERIMENTALParticipants with severe renal impairment will receive a single oral dose of AZD4144 on Day 1.
Cohort 2: AZD4144EXPERIMENTALHealthy participants with normal renal function will receive a single oral dose of AZD4144 on Day 1.
Cohort 3: AZD4144EXPERIMENTALParticipants with ESKD on intermittent haemodialysis will receive a single oral dose of AZD4144 on the first day of Treatment Period 1 and Treatment Period 2.
Cohort 4: AZD4144EXPERIMENTALParticipants with moderate renal impairment will receive a single oral dose of AZD4144 on Day 1.
Cohort 5: AZD4144EXPERIMENTALParticipants with mild renal impairment will receive a single oral dose of AZD4144 on Day 1.
Interventions
NameTypeDescription
AZD4144DRUGIntravenous solution of AZD4144 will be administered to randomised participants according to the treatment arm to which they have been assigned.
PlaceboDRUGIntravenous solution of Placebo will be administered to randomised participants according to the treatment arm to which they have been assigned.
ItraconazoleDRUGItraconazole will be administered orally.
OmeprazoleDRUGParticipants will receive omeprazole orally.
RosuvastatinDRUGOral tablet of rosuvastatin will be administered.
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Eligibility Criteria
Age Range18 Years to 80 Years
SexALL
Healthy VolunteersNo
Study Sites72

Inclusion Criteria Age ≥ 18 to ≤ 80 years at the time of signing the informed consent. Participants who are admitted to an ICU or an equivalent critical-care unit. Diagnosis of sepsis according to criteria defined by The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-...

Countries:United StatesArgentinaBelgiumCanadaCzechiaDenmarkFranceGermanyGreeceHungaryItalySpainTurkey (Türkiye)United KingdomBulgariaRomania
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Competitive Landscape -Sepsis 17 trials
CompanyTickerTrialsLead PhaseDrugs
AstraZeneca PLCAZN1PHASE2AZD4144
ImmunityBio IncIBRX1PHASE2Nogapendekin alfa inbakicept
Bluejay Diagnostics, Inc.BJDX2 - Undisclosed
CytoSorbents CorporationCTSO1 - Undisclosed
Danaher CorporationDHR3 - Undisclosed
Spectral AI, Inc. Class AMDAI1N/AUndisclosed
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Recent Changes (Last 90 Days)
LOWJul 6, 2026NCT07685600NEW_TRIAL: changed
LOWJul 6, 2026NCT07685600NEW_TRIAL: changed
LOWJun 23, 2026NCT07215702lastUpdatePostDate: changed
LOWJun 23, 2026NCT07215702lastUpdatePostDate: changed
LOWMay 26, 2026NCT07215702primaryCompletionDate: changed
LOWMay 24, 2026NCT07215702studyFirstPostDate: changed