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AZD4144 for Infusion

Phase 1

Healthy Participants | Small molecule | Other |AstraZeneca PLC|Last Updated: Jun 22, 2026

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment16

FDA Designations

No designations recorded

Clinical trial landscape

AZD4144 for Infusion · 1 trial · 1 indication

Phase 1 1
NCT07518459A Study of Absorption, Distribution, Metabolism and Excretion (ADME) of [14C]AZD4144Healthy Participants
COMPLETED16 Analytics
PHASE1COMPLETED
A Study of Absorption, Distribution, Metabolism and Excretion (ADME) of [14C]AZD4144
Healthy ParticipantsUnlock trial analytics

Study Endpoints

Primary Endpoints

Amount of AZD4144 excreted (Ae)
Urine and faecal samples collected from pre-dose until up to 216 hours post-dose

Mass balance recovery, rates and routes of elimination of total radioactivity of \[14C\]AZD4144 in urine, faecal and all excreta

Amount of AZD4144 excreted expressed as a percentage of the radioactive dose administered (Fe)
Urine and faecal samples collected from pre-dose until up to 216 hours post-dose

Mass balance recovery, rates and routes of elimination of total radioactivity of \[14C\]AZD4144 in urine, faeces and all excreta

Cumulative amount of AZD4144 excreted (CumAe)
Urine and faecal samples collected from pre-dose until up to 216 hours post-dose

Mass balance recovery, rates and routes of elimination of total radioactivity of \[14C\]AZD4144 in urine, faecal and all excreta

Cumulative amount of AZD4144 excreted expressed as a percentage of the radioactive dose administered (CumFe)
Urine and faecal samples collected from pre-dose until up to 216 hours post-dose

Mass balance recovery, rates and routes of elimination of total radioactivity of \[14C\]AZD4144 in urine, faecal and all excreta

Area under the curve (AUC) of circulating plasma total radioactivity (TR) accounting for 10% or more of the dose
Plasma, urine and faecal samples from pre-dose until up to 216 hours post-dose

Identification of the chemical structure of each metabolite accounting for more than 10% by AUC of circulating total radioactivity

80% or more of the radioactivity recovered in excreta
Plasma, urine and faecal samples from pre-dose until up to 216 hours post-dose

Identification of greater than 80% of the radioactivity recovered in the urine and/or faeces

Secondary Endpoints

Time of maximum observed concentration (tmax) for AZD4144 and total radioactivity
Plasma, urine and whole blood samples collected from pre-dose until up to 168 hours post-dose
Maximum observed concentration (Cmax) for AZD4144 and total radioactivity
Plasma, urine and whole blood samples collected from pre-dose until up to 168 hours post-dose
Area under the curve from time 0 to the time of last measurable concentration (AUC0-t) for AZD4144 and total radioactivity
Plasma, urine and whole blood samples collected from pre-dose until up to 168 hours post-dose
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Regimen AEXPERIMENTALParticipants in Cohort 1 will receive a single intravenous injection of \[14C\]AZD4144 Solution for Infusion
Regimen BEXPERIMENTALParticipants in Cohort 2 will receive a single oral dose of \[14C\]AZD4144 Oral Solution

Interventions

NameTypeDescription
[14C]AZD4144 Solution for InfusionDRUGIntravenous, fasted
[14C]AZD4144 Oral SolutionDRUGOral, fasted
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Eligibility Criteria

Age Range30 Years to 65 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy males aged 30 to 65 years inclusive * BMI of 18.0 to 32.0 kg/m2 inclusive * Regular bowel movements (i.e. average stool production of ≥1 and ≤3 stools per day) Exclusion Criteria: * History of any clinically important disease or disorder * History or presence of clin...

Countries:United Kingdom
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Recent Changes (Last 90 Days)

MEDIUMJul 23, 2026NCT07518459TRIAL_REMOVED: changed
MEDIUMJul 23, 2026NCT07518459TRIAL_REMOVED: changed
MEDIUMJul 23, 2026NCT07518459TRIAL_REMOVED: changed
HIGHJun 22, 2026NCT07518459Status: ACTIVE_NOT_RECRUITING → COMPLETED
HIGHJun 22, 2026NCT07518459Status: ACTIVE_NOT_RECRUITING → COMPLETED

Frequently asked questions about AZD4144 for Infusion

What is AZD4144 for Infusion used for?

AZD4144 for Infusion is an investigational small molecule being studied in healthy participants. It is currently in Phase 1 clinical development, with a completed trial evaluating its absorption, distribution, metabolism, and excretion. The drug is not approved and remains under investigation.

Who makes AZD4144 for Infusion?

AZD4144 for Infusion is being developed by AstraZeneca PLC, a biopharmaceutical company listed on the stock exchange under the ticker AZN. The company is conducting early-stage clinical research on this investigational small molecule.

What phase is AZD4144 for Infusion in?

AZD4144 for Infusion is in Phase 1 clinical development. One Phase 1 trial has been completed, involving 16 healthy participants in the United Kingdom. The drug is investigational and has not been approved for any use.

What clinical trials is AZD4144 for Infusion in?

AZD4144 for Infusion has one completed clinical trial, NCT07518459, titled "A Study of Absorption, Distribution, Metabolism and Excretion (ADME) of [14C]AZD4144." This Phase 1 study enrolled 16 healthy participants aged 30 years and older in the United Kingdom.

Is AZD4144 for Infusion FDA approved?

AZD4144 for Infusion is not FDA approved. It is an investigational drug currently in Phase 1 clinical development. A single Phase 1 trial has been completed, but the drug remains under study and has not been authorized for commercial use.