A 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 Participants
← catalyst calendarSponsored by AstraZeneca (industry) · AZN — their whole pipeline →.
Phase
Phase 1
Status
Completed
Study type
Interventional
Design
Randomized · Double · Treatment
Enrollment
147actual
Sites
1
Country
United States
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2024-08-02 | actual | When the study began enrolling |
| Primary completion | 2025-06-01 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2025-11-15 | actual | The whole study's end, after follow-up |
| First posted | 2024-07-16 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2025-12-11 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Healthy Participants
Interventions
- Drug: AZD8965
- Other: Placebo
Primary outcomes
what the primary-completion date above is the date OFParts 1 and 3A: Number of participants with adverse events (AEs) and serious adverse events (SAEs)
measured SAEs: From Screening (Day -28) to 5 weeks; AEs: From Day 1 to 5 weeks
Parts 2 and 3B: Number of participants with AEs and SAEs
measured SAEs: From Screening (Day -28) to 8 weeks; AEs: From Day 1 to 8 weeks.
Part 4: Maximum observed drug concentration (Cmax)
measured From Day 1 (pre-dose) to Day 7 (72-hour post dose)
Part 4: Area under concentration-time curve from time 0 to infinity (AUCinf)
measured From Day 1 (pre-dose) to Day 7 (72-hour post dose)
Part 4: Area under concentration-curve from time 0 to the last quantifiable concentration (AUClast)
measured From Day 1 (pre-dose) to Day 7 (72-hour post dose)
Part 4: Time to reach maximum observed concentration (tmax)
measured From Day 1 (pre-dose) to Day 7 (72-hour post dose)
Part 4: Partial area under the concentration-time curve from time t1 to time t2 [AUC(t1-t2)]
measured From Day 1 (pre-dose) to Day 7 (72-hour post dose)
Part 4: Terminal elimination half-life (t½λz)
measured From Day 1 (pre-dose) to Day 7 (72-hour post dose)
Part 4: Mean Residence Time (MRTinf)
measured From Day 1 (pre-dose) to Day 7 (72-hour post dose)
Part 4: Apparent total body clearance (CL/F)
measured From Day 1 (pre-dose) to Day 7 (72-hour post dose)
Part 4: Apparent volume of distribution based on the terminal (Vz/F)
measured From Day 1 (pre-dose) to Day 7 (72-hour post dose)
Part 4: Accumulation ratio for AUC (Rac AUC)
measured From Day 1 (pre-dose) to Day 7 (72-hour post dose)
Part 4: Accumulation ratio for Cmax (Rac Cmax)
measured From Day 1 (pre-dose) to Day 7 (72-hour post dose)
Part 4: Individual and cumulative amount of unchanged drug excreted into urine from time t1 to time t2 [Ae(t1-t2)]
measured From Day 1 (pre-dose) to Day 5
Part 4: Individual and cumulative percentage of dose excreted unchanged in urine from time t1 to time t2 [fe(t1-t2)]
measured From Day 1 (pre-dose) to Day 5
Part 4: Relative bioavailability calculated as test AUC/reference AUC (Frel AUC)
measured From Day 1 (pre-dose) to Day 7 (72-hour post dose)
Part 4: Relative bioavailability calculated as test Cmax/reference Cmax (Frel Cmax)
measured From Day 1 (pre-dose) to Day 7 (72-hour post dose)
Part 4: Renal clearance (CLR)
measured From Day 1 (pre-dose) to Day 5
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