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AZD6234 Formulation 1

Phase 1

Healthy Participants | Small molecule | Other |AstraZeneca PLC|Last Updated: May 18, 2026

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 Enrollment21
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07220954A Study to Assess the Relative Bioavailability of Different Subcutaneous Formulations ofAZD6234PHASE1 RECRUITING 21Nov 11, 2025Apr 1, 2027May 18, 20261 United Kingdom
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Study Endpoints
Primary Endpoints
Maximum observed plasma concentration (Cmax)
Plasma sample collection from pre- dose to 30 days post final dose

Assess relative bioavailability (rBA) by comparing the pharmacokinetics (PK) of different AZD6234 SC formulations

Area under the concentration-time curve from time 0 to the time of the last measurable concentration (AUC0-t)
Plasma sample collection from pre- dose to 30 days post final dose

Assess relative bioavailability (rBA) by comparing the pharmacokinetics (PK) of different AZD6234 SC formulations

Area under the concentration-time curve from time 0 extrapolated to infinity (AUC0-inf)
Plasma sample collection from pre- dose to 30 days post final dose

Assess relative bioavailability (rBA) by comparing the pharmacokinetics (PK) of different AZD6234 SC formulations

Secondary Endpoints
Number of subjects with adverse events (AEs)/serious AEs (SAEs), and change from baseline for vital signs, electrocardiograms (ECGs), and laboratory safety tests
Through study duration, approximately 19 weeks
Time of maximum observed plasma concentration (tmax)
Plasma sample collection from pre- dose to 30 days post final dose
Terminal elimination half-life (t1/2)
Plasma sample collection from pre- dose to 30 days post final dose
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Sequence ABCDEXPERIMENTALParticipants will receive a single SC injection of AZD6234 in each of four study periods, Treatment A in Period 1, Treatment B in Period 2, Treatment C in Period 3 and Treatment D in Period 4 (Where A is AZD6234 Formulation 1, B is AZD6234 Formulation 2 (low concentration), C is AZD6234 Formulation 2 (high concentration) and D is AZD6234 Formulation 3)
Sequence BCADEXPERIMENTALParticipants will receive a single SC injection of AZD6234 in each of four study periods, Treatment B in Period 1, Treatment C in Period 2, Treatment A in Period 3 and Treatment D in Period 4 (Where A is AZD6234 Formulation 1, B is AZD6234 Formulation 2 (low concentration), C is AZD6234 Formulation 2 (high concentration) and D is AZD6234 Formulation 3)
Sequence CABDEXPERIMENTALParticipants will receive a single SC injection of AZD6234 in each of four study periods, Treatment C in Period 1, Treatment A in Period 2, Treatment B in Period 3 and Treatment D in Period 4 (Where A is AZD6234 Formulation 1, B is AZD6234 Formulation 2 (low concentration), C is AZD6234 Formulation 2 (high concentration) and D is AZD6234 Formulation 3)
Interventions
NameTypeDescription
AZD6234 Formulation 1DRUGAZD6234 Formulation 1 will be administered as a single SC injection
AZD6234 Formulation 2 (low concentration)DRUGAZD6234 Formulation 2 (low concentration) will be administered as a single SC injection
AZD6234 Formulation 2 (high concentration)DRUGAZD6234 Formulation 2 (high concentration) will be administered as a single SC injection
AZD6234 Formulation 3DRUGAZD6234 Formulation 3 will be administered as a single SC injection
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Eligibility Criteria
Age Range18 Years — 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy males or non-pregnant, non-lactating females aged 18 to 55 years inclusive * BMI of 25.0 to 35.0 kg/m2 inclusive and weight ≥50 kg Exclusion Criteria: * History of any clinically important disease or disorder * History or presence of clinically significant cardiovasc...

Countries:United Kingdom
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Recent Changes (Last 90 Days)
MEDIUMMay 26, 2026NCT07220954Status: NOT_YET_RECRUITING → RECRUITING
LOWMay 24, 2026NCT07220954studyFirstPostDate: changed