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AZD8965

Phase 1

Healthy Participants | Small molecule | Other |AstraZeneca PLC|Last Updated: Dec 11, 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
RandomizedDouble-BlindCONTROLLEDBiomarker
Total Trials1
Total Enrollment147
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06502379A Single and Multiple Ascending Dose Study to Investigate the Safety, Tolerability, and Pharmacokinetics of AZD8965 in Healthy Participants (Including Japanese and Chinese Participants) and an Open-label Cohort to Assess the Effect of Food on the Pharmacokinetics of AZD8965 in Healthy ParticipantsPHASE1 COMPLETED 147 — — Aug 2, 2024Nov 15, 2025Dec 11, 20251 United States
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Study Endpoints
Primary Endpoints
Parts 1 and 3A: Number of participants with adverse events (AEs) and serious adverse events (SAEs)
SAEs: From Screening (Day -28) to 5 weeks; AEs: From Day 1 to 5 weeks

To assess the safety and tolerability of AZD8965 following oral administration of single ascending doses to healthy participants.

Parts 2 and 3B: Number of participants with AEs and SAEs
SAEs: From Screening (Day -28) to 8 weeks; AEs: From Day 1 to 8 weeks.

To assess the safety and tolerability of AZD8965 following oral administration of multiple ascending doses to healthy participants.

Part 4: Maximum observed drug concentration (Cmax)
From Day 1 (pre-dose) to Day 7 (72-hour post dose)

To assess the effect of a high fat meal compared to fasting conditions on the PK of active drug and pro-drug following oral administration of AZD8965 in healthy participants.

Part 4: Area under concentration-time curve from time 0 to infinity (AUCinf)
From Day 1 (pre-dose) to Day 7 (72-hour post dose)

To assess the effect of a high fat meal compared to fasting conditions on the PK of active drug and pro-drug following oral administration of AZD8965 in healthy participants.

Part 4: Area under concentration-curve from time 0 to the last quantifiable concentration (AUClast)
From Day 1 (pre-dose) to Day 7 (72-hour post dose)

To assess the effect of a high fat meal compared to fasting conditions on the PK of active drug and pro-drug following oral administration of AZD8965 in healthy participants.

Part 4: Time to reach maximum observed concentration (tmax)
From Day 1 (pre-dose) to Day 7 (72-hour post dose)

To assess the effect of a high fat meal compared to fasting conditions on the PK of active drug and pro-drug following oral administration of AZD8965 in healthy participants.

Part 4: Partial area under the concentration-time curve from time t1 to time t2 [AUC(t1-t2)]
From Day 1 (pre-dose) to Day 7 (72-hour post dose)

To assess the effect of a high fat meal compared to fasting conditions on the PK of active drug and pro-drug following oral administration of AZD8965 in healthy participants.

Part 4: Terminal elimination half-life (t½λz)
From Day 1 (pre-dose) to Day 7 (72-hour post dose)

To assess the effect of a high fat meal compared to fasting conditions on the PK of active drug and pro-drug following oral administration of AZD8965 in healthy participants.

Part 4: Mean Residence Time (MRTinf)
From Day 1 (pre-dose) to Day 7 (72-hour post dose)

To assess the effect of a high fat meal compared to fasting conditions on the PK of active drug and pro-drug following oral administration of AZD8965 in healthy participants.

Part 4: Apparent total body clearance (CL/F)
From Day 1 (pre-dose) to Day 7 (72-hour post dose)

To assess the effect of a high fat meal compared to fasting conditions on the PK of active drug and pro-drug following oral administration of AZD8965 in healthy participants.

Part 4: Apparent volume of distribution based on the terminal (Vz/F)
From Day 1 (pre-dose) to Day 7 (72-hour post dose)

To assess the effect of a high fat meal compared to fasting conditions on the PK of active drug and pro-drug following oral administration of AZD8965 in healthy participants.

Part 4: Accumulation ratio for AUC (Rac AUC)
From Day 1 (pre-dose) to Day 7 (72-hour post dose)

To assess the effect of a high fat meal compared to fasting conditions on the PK of active drug and pro-drug following oral administration of AZD8965 in healthy participants.

Part 4: Accumulation ratio for Cmax (Rac Cmax)
From Day 1 (pre-dose) to Day 7 (72-hour post dose)

To assess the effect of a high fat meal compared to fasting conditions on the PK of active drug and pro-drug following oral administration of AZD8965 in healthy participants.

Part 4: Individual and cumulative amount of unchanged drug excreted into urine from time t1 to time t2 [Ae(t1-t2)]
From Day 1 (pre-dose) to Day 5

To assess the effect of a high fat meal compared to fasting conditions on the PK of active drug and pro-drug following oral administration of AZD8965 in healthy participants.

Part 4: Individual and cumulative percentage of dose excreted unchanged in urine from time t1 to time t2 [fe(t1-t2)]
From Day 1 (pre-dose) to Day 5

To assess the effect of a high fat meal compared to fasting conditions on the PK of active drug and pro-drug following oral administration of AZD8965 in healthy participants.

Part 4: Relative bioavailability calculated as test AUC/reference AUC (Frel AUC)
From Day 1 (pre-dose) to Day 7 (72-hour post dose)

To assess the effect of a high fat meal compared to fasting conditions on the PK of active drug and pro-drug following oral administration of AZD8965 in healthy participants.

Part 4: Relative bioavailability calculated as test Cmax/reference Cmax (Frel Cmax)
From Day 1 (pre-dose) to Day 7 (72-hour post dose)

To assess the effect of a high fat meal compared to fasting conditions on the PK of active drug and pro-drug following oral administration of AZD8965 in healthy participants.

Part 4: Renal clearance (CLR)
From Day 1 (pre-dose) to Day 5

To assess the effect of a high fat meal compared to fasting conditions on the PK of active drug and pro-drug following oral administration of AZD8965 in healthy participants.

Secondary Endpoints
Parts 1, 2, 3A and 3B: Maximum observed drug concentration (Cmax)
Parts 1 and 3A: From Day 1 (pre-dose) to Day 4 (72-hour post dose); Parts 2 and 3B: From Day 1 (pre-dose) to Day 10 (48-hour post dose)
Parts 1, 2, 3A and 3B: Area under concentration-time curve from time 0 to infinity (AUCinf)
Parts 1 and 3A: From Day 1 (pre-dose) to Day 4 (72-hour post dose); Parts 2 and 3B: From Day 1 (pre-dose) to Day 10 (48-hour post dose)
Parts 1, 2, 3A and 3B: Area under concentration-curve from time 0 to the last quantifiable concentration (AUClast)
Parts 1 and 3A: From Day 1 (pre-dose) to Day 4 (72-hour post dose); Parts 2 and 3B: From Day 1 (pre-dose) to Day 10 (48-hour post dose)
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Part 1: SAD Cohort 1 - AZD8965 (Dose 1)EXPERIMENTALParticipants will receive a single dose of AZD8965 (Dose 1) or matching placebo to AZD8965 on Day 1.
Part 1: SAD Cohort 2 - AZD8965 (Dose 2)EXPERIMENTALParticipants will receive a single dose of AZD8965 (Dose 2) or matching placebo to AZD8965 on Day 1.
Part 1: SAD Cohort 3 - AZD8965 (Dose 3)EXPERIMENTALParticipants will receive a single dose of AZD8965 (Dose 3) or matching placebo to AZD8965 on Day 1.
Part 1: SAD Cohort 4 - AZD8965 (Dose 4)EXPERIMENTALParticipants will receive a single dose of AZD8965 (Dose 4) or matching placebo to AZD8965 on Day 1.
Part 1: SAD Cohort 5 - AZD8965 (Dose 5)EXPERIMENTALParticipants will receive a single dose of AZD8965 (Dose 5) or matching placebo to AZD8965 on Day 1.
Part 2: MAD Cohort 1 - AZD8965 (Dose 1)EXPERIMENTALParticipants will receive multiple doses of AZD8965 (Dose 1) or matching placebo to AZD8965 from Day 1 to Day 8.
Part 2: MAD Cohort 2 - AZD8965 (Dose 2)EXPERIMENTALParticipants will receive multiple doses of AZD8965 (Dose 2) or matching placebo to AZD8965 from Day 1 to Day 8.
Part 2: MAD Cohort 3 - AZD8965 (Dose 3)EXPERIMENTALParticipants will receive multiple doses of AZD8965 (Dose 3) or matching placebo to AZD8965 from Day 1 to Day 8.
Part 3A: SAD Cohort 1 (Japanese) - AZD8965 (Dose 1)EXPERIMENTALJapanese participants will receive a single dose of AZD8965 (Dose 1) or matching placebo to AZD8965 on Day 1.
Part 3A: SAD Cohort 2 (Japanese) - AZD8965 (Dose 2)EXPERIMENTALJapanese participants will receive a single dose of AZD8965 (Dose 2) or matching placebo to AZD8965 on Day 1.
Part 3A: SAD Cohort 3 (Chinese) - AZD8965 (Dose 1)EXPERIMENTALChinese participants will receive a single dose of AZD8965 (Dose 1) or matching placebo to AZD8965 on Day 1.
Part 3B: Single and multiple ascending dose (SMAD) Cohort 1 (Japanese) - AZD8965 (Dose 1)EXPERIMENTALJapanese participants will receive a single dose of AZD8965 (Dose 1) or matching placebo to AZD8965 on Day 1, followed by multiple doses of AZD8965 or matching placebo from Day 3 until Day 9.
Part 3B: SMAD Cohort 2 (Chinese) - AZD8965 (Dose 1)EXPERIMENTALChinese participants will receive a single dose of AZD8965 (Dose 1) or matching placebo to AZD8965 on Day 1, followed by multiple doses of AZD8965 or matching placebo from Day 3 until Day 9.
Part 4: Food Effect Cohort - AZD8965EXPERIMENTALParticipants will receive 2 single dose treatments of AZD8965 \[following an overnight fast of at least 10 hours in a fasted state or a fed state (after a high fat meal)\].
Interventions
NameTypeDescription
AZD8965DRUGAZD8965 will be administered orally.
PlaceboOTHERPlacebo will be administered orally.
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Eligibility Criteria
Age Range18 Years — 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy male and female participants (including Japanese and Chinese participants) with suitable veins for cannulation or repeated venipuncture. * All females of childbearing potential must have a negative pregnancy test at the Screening Visit (serum) and on admission (urine) ...

Countries:United States
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