Healthy ParticipantsPhase 1NCT06502379
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
A Phase 1 study testing AZD8965 in people with Healthy Participants, run by AstraZeneca at 1 site in United States.
Trial summary
The purpose of this study is to assess the safety, tolerability, and pharmacokinetics (PK) of AZD8965 via single and multiple ascending doses in healthy participants (including Japanese and Chinese participants), and to assess the effect of food on the safety, tolerability, and PK of orally administered AZD8965. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants
- What is being tested?
- AZD8965
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 147 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Aug 2024to 15 Nov 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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) to the Clinical Unit.
- All females of childbearing potential must not be lactating and if heterosexually active must agree to use an approved method of highly effective contraception with low user dependency and their non-sterilized male partners must use a condom, to avoid pregnancy from the time of first administration of study intervention until 20 days after the last dose of study intervention. Females must not use hormonal contraceptives or hormone replacement therapy during the study.
- Females of non-childbearing potential must be confirmed at the Screening Visit by fulfilling one of the following criteria:
- Postmenopausal defined as amenorrhea for at least 12 months following cessation of all exogenous hormonal treatments and without an alternative medical cause and the follicle stimulating hormone (FSH) level is in the postmenopausal range.
- Documentation of irreversible surgical sterilization by hysterectomy, bilateral oophorectomy, or bilateral salpingectomy. Tubal ligation is not acceptable.
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- Sexually active fertile male participants with partners of childbearing potential must adhere to the specified contraception methods from the time of first administration of study intervention administration until 20 days after the last dose of study intervention.
- Have a body mass index (BMI) between 18 and 30 kilogram (kg)/square meter (m2) inclusive and weigh at least 45 kg.
- Part 3A and Part 3B (Japanese Participants)
- Healthy Japanese participants are eligible based on meeting all of the following:
- Born in Japan
- Have 2 Japanese biological parents and 4 Japanese grandparents.
- Did not live outside Japan for more than 10 years at the time of Screening. Part 3A and Part 3B (Chinese Participants)
- Healthy Chinese participants. Participants of Chinese ancestry are eligible based on meeting all of the following:
- Born in mainland China, Hong Kong, Macau, or Taiwan
- Have 2 Chinese biological parents and 4 Chinese grandparents as confirmed by the interview.
- Did not live outside China for more than 10 years at the time of Screening.
Who cannot join
- History of any clinically important disease or disorder which may either put the participant at risk or influence the results or the participant's ability to participate in the study.
- Chronic or ongoing gastrointestinal, respiratory, hepatic, renal disease, pancreatic disease, diabetes mellitus, or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs.
- Chronic or ongoing neurological disorder, any clinically important past or ongoing psychiatric disorder which may confound assessment of the potential neurologic effects of this product.
- Participants with a history of hypertension or cardiovascular disease.
- Any clinically important illness, medical/surgical procedure, or trauma within 4 weeks of the first administration of study intervention.
- Participant with chronic infections (e.g., urinary tract infection) or who are at increased risk of infection (e.g., surgery, trauma, severe dental disease, or significant infection).
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- Participants with a known or suspected defect in the function of the urea cycle, or with family history of a urea cycle disorder in one or more biological relative.
- Any abnormal laboratory values and vital signs.
- Ongoing acquired or inherited immunodeficiency disorders, including but not limited to human immunodeficiency virus (HIV) or common variable immunodeficiency, or the participant is taking immune replacement therapy.
- History of severe allergy/hypersensitivity or ongoing clinically important allergy/hypersensitivity, or history of hypersensitivity to drugs with a similar chemical structure or class to AZD8965.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I Randomized, Single-blind, Placebo-controlled Study to Assess the Safety, Tolerability, and Pharmacokinetics of AZD8965 Following Single and Multiple Ascending Dose Administration to 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
The purpose of this study is to assess the safety, tolerability, and pharmacokinetics (PK) of AZD8965 via single and multiple ascending doses in healthy participants (including Japanese and Chinese participants), and to assess the effect of food on the safety, tolerability, and PK of orally administered AZD8965.
Read the detailed description
This is a first in human single and multiple ascending dose study. The study consists of 4 parts: Part 1 (single ascending dose [SAD]), Part 2 (multiple ascending dose [MAD]), Part 3A (Japanese and Chinese SAD), Part 3B (Japanese and Chinese combined SAD and MAD), and Part 4 (Food Effect).
Each study part includes a 28-day screening period and a residential period during which participants will be resident at the Clinical Unit from the day before study intervention administration (Day -1) until at least 48-72 hours after the study intervention administration.
- Conditions
- Healthy Participants
- Being tested
- AZD8965, Placebo
- Keywords
- Idiopathic Pulmonary Fibrosis, Lung disease, Pharmacokinetics, Food Effect
- Medical subject headings
- Idiopathic Pulmonary Fibrosis, Lung Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD8965Drug
AZD8965 will be administered orally.
PlaceboOther
Placebo will be administered orally.
| Study group | Role | What they receive |
|---|---|---|
| Part 1: SAD Cohort 1 - AZD8965 (Dose 1) | Experimental | Participants will receive a single dose of AZD8965 (Dose 1) or matching placebo to AZD8965 on Day 1. Receives: Drug: AZD8965; Other: Placebo |
| Part 1: SAD Cohort 2 - AZD8965 (Dose 2) | Experimental | Participants will receive a single dose of AZD8965 (Dose 2) or matching placebo to AZD8965 on Day 1. Receives: Drug: AZD8965; Other: Placebo |
| Part 1: SAD Cohort 3 - AZD8965 (Dose 3) | Experimental | Participants will receive a single dose of AZD8965 (Dose 3) or matching placebo to AZD8965 on Day 1. Receives: Drug: AZD8965; Other: Placebo |
| Part 1: SAD Cohort 4 - AZD8965 (Dose 4) | Experimental | Participants will receive a single dose of AZD8965 (Dose 4) or matching placebo to AZD8965 on Day 1. Receives: Drug: AZD8965; Other: Placebo |
| Part 1: SAD Cohort 5 - AZD8965 (Dose 5) | Experimental | Participants will receive a single dose of AZD8965 (Dose 5) or matching placebo to AZD8965 on Day 1. Receives: Drug: AZD8965; Other: Placebo |
| Part 2: MAD Cohort 1 - AZD8965 (Dose 1) | Experimental | Participants will receive multiple doses of AZD8965 (Dose 1) or matching placebo to AZD8965 from Day 1 to Day 8. Receives: Drug: AZD8965; Other: Placebo |
| Part 2: MAD Cohort 2 - AZD8965 (Dose 2) | Experimental | Participants will receive multiple doses of AZD8965 (Dose 2) or matching placebo to AZD8965 from Day 1 to Day 8. Receives: Drug: AZD8965; Other: Placebo |
| Part 2: MAD Cohort 3 - AZD8965 (Dose 3) | Experimental | Participants will receive multiple doses of AZD8965 (Dose 3) or matching placebo to AZD8965 from Day 1 to Day 8. Receives: Drug: AZD8965; Other: Placebo |
| Part 3A: SAD Cohort 1 (Japanese) - AZD8965 (Dose 1) | Experimental | Japanese participants will receive a single dose of AZD8965 (Dose 1) or matching placebo to AZD8965 on Day 1. Receives: Drug: AZD8965; Other: Placebo |
| Part 3A: SAD Cohort 2 (Japanese) - AZD8965 (Dose 2) | Experimental | Japanese participants will receive a single dose of AZD8965 (Dose 2) or matching placebo to AZD8965 on Day 1. Receives: Drug: AZD8965; Other: Placebo |
| Part 3A: SAD Cohort 3 (Chinese) - AZD8965 (Dose 1) | Experimental | Chinese participants will receive a single dose of AZD8965 (Dose 1) or matching placebo to AZD8965 on Day 1. Receives: Drug: AZD8965; Other: Placebo |
| Part 3B: Single and multiple ascending dose (SMAD) Cohort 1 (Japanese) - AZD8965 (Dose 1) | Experimental | Japanese 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. Receives: Drug: AZD8965; Other: Placebo |
| Part 3B: SMAD Cohort 2 (Chinese) - AZD8965 (Dose 1) | Experimental | Chinese 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. Receives: Drug: AZD8965; Other: Placebo |
| Part 4: Food Effect Cohort - AZD8965 | Experimental | Participants 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)]. Receives: Drug: AZD8965 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Parts 1 and 3A: Number of participants with adverse events (AEs) and serious adverse events (SAEs)
To assess the safety and tolerability of AZD8965 following oral administration of single ascending doses to healthy participants.
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
To assess the safety and tolerability of AZD8965 following oral administration of multiple ascending doses to healthy participants.
Measured: SAEs: From Screening (Day -28) to 8 weeks; AEs: From Day 1 to 8 weeks.
Part 4: Maximum observed drug concentration (Cmax)
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.
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)
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.
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)
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.
Measured: From Day 1 (pre-dose) to Day 7 (72-hour post dose)
Part 4: Time to reach maximum observed concentration (tmax)
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.
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)]
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.
Measured: From Day 1 (pre-dose) to Day 7 (72-hour post dose)
Part 4: Terminal elimination half-life (t½λz)
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.
Measured: From Day 1 (pre-dose) to Day 7 (72-hour post dose)
Part 4: Mean Residence Time (MRTinf)
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.
Measured: From Day 1 (pre-dose) to Day 7 (72-hour post dose)
Part 4: Apparent total body clearance (CL/F)
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.
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)
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.
Measured: From Day 1 (pre-dose) to Day 7 (72-hour post dose)
Part 4: Accumulation ratio for AUC (Rac AUC)
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.
Measured: From Day 1 (pre-dose) to Day 7 (72-hour post dose)
Part 4: Accumulation ratio for Cmax (Rac Cmax)
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.
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)]
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.
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)]
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.
Measured: From Day 1 (pre-dose) to Day 5
Part 4: Relative bioavailability calculated as test AUC/reference AUC (Frel AUC)
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.
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)
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.
Measured: From Day 1 (pre-dose) to Day 7 (72-hour post dose)
Part 4: Renal clearance (CLR)
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.
Measured: From Day 1 (pre-dose) to Day 5
Secondary outcomes (17)
Parts 1, 2, 3A and 3B: Maximum observed drug concentration (Cmax)
To characterize the PK of active drug and pro-drug following oral administration of single and multiple ascending doses of AZD8965 in healthy participants.
Measured: 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)
To characterize the PK of active drug and pro-drug following oral administration of single and multiple ascending doses of AZD8965 in healthy participants.
Measured: 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)
To characterize the PK of active drug and pro-drug following oral administration of single and multiple ascending doses of AZD8965 in healthy participants.
Measured: 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: Time to reach maximum observed concentration (tmax)
To characterize the PK of active drug and pro-drug following oral administration of single and multiple ascending doses of AZD8965 in healthy participants.
Measured: 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: Partial area under the concentration-time curve from time t1 to time t2 [AUC(t1-t2)]
To characterize the PK of active drug and pro-drug following oral administration of single and multiple ascending doses of AZD8965 in healthy participants.
Measured: 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: Terminal elimination half-life (t½λz)
To characterize the PK of active drug and pro-drug following oral administration of single and multiple ascending doses of AZD8965 in healthy participants.
Measured: 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: Mean Residence Time (MRTinf)
To characterize the PK of active drug and pro-drug following oral administration of single and multiple ascending doses of AZD8965 in healthy participants.
Measured: 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: Apparent total body clearance (CL/F)
To characterize the PK of active drug and pro-drug following oral administration of single and multiple ascending doses of AZD8965 in healthy participants.
Measured: 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: Apparent volume of distribution based on the terminal (Vz/F)
To characterize the PK of active drug and pro-drug following oral administration of single and multiple ascending doses of AZD8965 in healthy participants.
Measured: 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: Individual and cumulative amount of unchanged drug excreted into urine from time t1 to time t2 [Ae(t1-t2)]
To characterize the PK of active drug and pro-drug following oral administration of single and multiple ascending doses of AZD8965 in healthy participants.
Measured: Parts 1 and 3A: Up to Day 2; Parts 2 and 3B: Days 1, 2, 8, 9
Parts 1, 2, 3A and 3B: Individual and cumulative percentage of dose excreted unchanged in urine from time t1 to time t2 [fe(t1-t2)]
To characterize the PK of active drug and pro-drug following oral administration of single and multiple ascending doses of AZD8965 in healthy participants.
Measured: Parts 1 and 3A: Up to Day 2; Parts 2 and 3B: Days 1, 2, 8, 9
Parts 1, 2, 3A and 3B: Renal clearance (CLR)
To characterize the PK of active drug and pro-drug following oral administration of single and multiple ascending doses of AZD8965 in healthy participants.
Measured: Parts 1 and 3A: Up to Day 2; Parts 2 and 3B: Days 1, 2, 8, 9
Parts 2 and 3B: Area under concentration-time curve in the dosing interval (AUCtau)
To characterize the PK of active drug and pro-drug following oral administration of multiple ascending doses of AZD8965 in healthy participants.
Measured: From Day 1 (pre-dose) to Day 10 (48-hour post dose)
Parts 2 and 3B: Accumulation ratio for AUC (Rac AUC)
To characterize the PK of active drug and pro-drug following oral administration of multiple ascending doses of AZD8965 in healthy participants.
Measured: From Day 1 (pre-dose) to Day 10 (48-hour post dose)
Parts 2 and 3B: Accumulation ratio for Cmax (Rac Cmax)
To characterize the PK of active drug and pro-drug following oral administration of multiple ascending doses of AZD8965 in healthy participants.
Measured: From Day 1 (pre-dose) to Day 10 (48-hour post dose)
Parts 2 and 3B: Temporal Change Parameter (TCP)
To characterize the PK of active drug and pro-drug following oral administration of multiple ascending doses of AZD8965 in healthy participants.
Measured: From Day 1 (pre-dose) to Day 10 (48-hour post dose)
Part 4: Number of participants with AEs and SAEs
To assess the safety and tolerability of AZD8965 under fasted and fed (after intake of a high fat meal) conditions in healthy participants.
Measured: SAEs: From Screening (Day -28) to 6 weeks; AEs: From Day 1 to 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2024
- Study start2 Aug 2024
- Primary completion1 Jun 2025
- Study completion15 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy ParticipantsStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 147 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06502379
- Sponsor's protocol ID
- D6960C00001
- Status last verified
- Nov 2025
- First submitted
- 9 Jul 2024
- Last updated
- 11 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. "Yes", indicates that AZ are accepting requests for IPD, but this does not mean all requests will be approved.
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Randomized, Single-blind, Placebo-controlled Study to Assess the Safety, Tolerability, and Pharmacokinetics of AZD8965 Following Single and Multiple Ascending Dose Administration to 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
- ClinicalTrials.gov ID
- NCT06502379
- Acronym / sponsor ID
- D6960C00001
- Conditions
- Healthy Participants
- Keywords
- Idiopathic Pulmonary Fibrosis, Lung disease, Pharmacokinetics, Food Effect
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 147 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 2 Aug 2024 (actual)
- Primary completion
- 1 Jun 2025 (actual)
- Study completion
- 15 Nov 2025 (actual)
- First posted
- 16 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess the safety, tolerability, and pharmacokinetics (PK) of AZD8965 via single and multiple ascending doses in healthy participants (including Japanese and Chinese participants), and to assess the effect of food on the safety, tolerability, and PK of orally administered AZD8965.
Detailed description
This is a first in human single and multiple ascending dose study. The study consists of 4 parts: Part 1 (single ascending dose [SAD]), Part 2 (multiple ascending dose [MAD]), Part 3A (Japanese and Chinese SAD), Part 3B (Japanese and Chinese combined SAD and MAD), and Part 4 (Food Effect).
Each study part includes a 28-day screening period and a residential period during which participants will be resident at the Clinical Unit from the day before study intervention administration (Day -1) until at least 48-72 hours after the study intervention administration.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, care provider)
- Number of arms
- 14
| Arm | Type | Receives |
|---|---|---|
| Part 1: SAD Cohort 1 - AZD8965 (Dose 1) | Experimental | Drug: AZD8965, Other: PlaceboParticipants 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) | Experimental | Drug: AZD8965, Other: PlaceboParticipants 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) | Experimental | Drug: AZD8965, Other: PlaceboParticipants 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) | Experimental | Drug: AZD8965, Other: PlaceboParticipants 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) | Experimental | Drug: AZD8965, Other: PlaceboParticipants 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) | Experimental | Drug: AZD8965, Other: PlaceboParticipants 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) | Experimental | Drug: AZD8965, Other: PlaceboParticipants 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) | Experimental | Drug: AZD8965, Other: PlaceboParticipants 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) | Experimental | Drug: AZD8965, Other: PlaceboJapanese 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) | Experimental | Drug: AZD8965, Other: PlaceboJapanese 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) | Experimental | Drug: AZD8965, Other: PlaceboChinese 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) | Experimental | Drug: AZD8965, Other: PlaceboJapanese 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) | Experimental | Drug: AZD8965, Other: PlaceboChinese 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 - AZD8965 | Experimental | Drug: AZD8965Participants 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)]. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (17 listed)
- 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) to the Clinical Unit.
- All females of childbearing potential must not be lactating and if heterosexually active must agree to use an approved method of highly effective contraception with low user dependency and their non-sterilized male partners must use a condom, to avoid pregnancy from the time of first administration of study intervention until 20 days after the last dose of study intervention. Females must not use hormonal contraceptives or hormone replacement therapy during the study.
- Females of non-childbearing potential must be confirmed at the Screening Visit by fulfilling one of the following criteria:
- Sexually active fertile male participants with partners of childbearing potential must adhere to the specified contraception methods from the time of first administration of study intervention administration until 20 days after the last dose of study intervention.
Key exclusion criteria (10 listed)
- History of any clinically important disease or disorder which may either put the participant at risk or influence the results or the participant's ability to participate in the study.
- Chronic or ongoing gastrointestinal, respiratory, hepatic, renal disease, pancreatic disease, diabetes mellitus, or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs.
- Chronic or ongoing neurological disorder, any clinically important past or ongoing psychiatric disorder which may confound assessment of the potential neurologic effects of this product.
- Participants with a history of hypertension or cardiovascular disease.
- Any clinically important illness, medical/surgical procedure, or trauma within 4 weeks of the first administration of study intervention.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AZD8965AZD8965 will be administered orally. | Drug | Part 1: SAD Cohort 1 - AZD8965 (Dose 1), Part 1: SAD Cohort 2 - AZD8965 (Dose 2), Part 1: SAD Cohort 3 - AZD8965 (Dose 3), Part 1: SAD Cohort 4 - AZD8965 (Dose 4), Part 1: SAD Cohort 5 - AZD8965 (Dose 5), Part 2: MAD Cohort 1 - AZD8965 (Dose 1), Part 2: MAD Cohort 2 - AZD8965 (Dose 2), Part 2: MAD Cohort 3 - AZD8965 (Dose 3), Part 3A: SAD Cohort 1 (Japanese) - AZD8965 (Dose 1), Part 3A: SAD Cohort 2 (Japanese) - AZD8965 (Dose 2), Part 3A: SAD Cohort 3 (Chinese) - AZD8965 (Dose 1), Part 3B: SMAD Cohort 2 (Chinese) - AZD8965 (Dose 1), Part 3B: Single and multiple ascending dose (SMAD) Cohort 1 (Japanese) - AZD8965 (Dose 1), Part 4: Food Effect Cohort - AZD8965 |
| PlaceboPlacebo will be administered orally. | Other | Part 1: SAD Cohort 1 - AZD8965 (Dose 1), Part 1: SAD Cohort 2 - AZD8965 (Dose 2), Part 1: SAD Cohort 3 - AZD8965 (Dose 3), Part 1: SAD Cohort 4 - AZD8965 (Dose 4), Part 1: SAD Cohort 5 - AZD8965 (Dose 5), Part 2: MAD Cohort 1 - AZD8965 (Dose 1), Part 2: MAD Cohort 2 - AZD8965 (Dose 2), Part 2: MAD Cohort 3 - AZD8965 (Dose 3), Part 3A: SAD Cohort 1 (Japanese) - AZD8965 (Dose 1), Part 3A: SAD Cohort 2 (Japanese) - AZD8965 (Dose 2), Part 3A: SAD Cohort 3 (Chinese) - AZD8965 (Dose 1), Part 3B: SMAD Cohort 2 (Chinese) - AZD8965 (Dose 1), Part 3B: Single and multiple ascending dose (SMAD) Cohort 1 (Japanese) - AZD8965 (Dose 1) |
Primary outcome
Parts 1 and 3A: Number of participants with adverse events (AEs) and serious adverse events (SAEs)
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)]
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)]
Time frame: 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)]
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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.
17 secondary outcomes
Parts 1, 2, 3A and 3B: Maximum observed drug concentration (Cmax)
Time frame: 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)
Time frame: 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)
Time frame: 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: Time to reach maximum observed concentration (tmax)
Time frame: 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: Partial area under the concentration-time curve from time t1 to time t2 [AUC(t1-t2)]
Time frame: 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: Terminal elimination half-life (t½λz)
Time frame: 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: Mean Residence Time (MRTinf)
Time frame: 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: Apparent total body clearance (CL/F)
Time frame: 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: Apparent volume of distribution based on the terminal (Vz/F)
Time frame: 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: Individual and cumulative amount of unchanged drug excreted into urine from time t1 to time t2 [Ae(t1-t2)]
Time frame: Parts 1 and 3A: Up to Day 2; Parts 2 and 3B: Days 1, 2, 8, 9
Parts 1, 2, 3A and 3B: Individual and cumulative percentage of dose excreted unchanged in urine from time t1 to time t2 [fe(t1-t2)]
Time frame: Parts 1 and 3A: Up to Day 2; Parts 2 and 3B: Days 1, 2, 8, 9
Parts 1, 2, 3A and 3B: Renal clearance (CLR)
Time frame: Parts 1 and 3A: Up to Day 2; Parts 2 and 3B: Days 1, 2, 8, 9
Parts 2 and 3B: Area under concentration-time curve in the dosing interval (AUCtau)
Time frame: From Day 1 (pre-dose) to Day 10 (48-hour post dose)
Parts 2 and 3B: Accumulation ratio for AUC (Rac AUC)
Time frame: From Day 1 (pre-dose) to Day 10 (48-hour post dose)
Parts 2 and 3B: Accumulation ratio for Cmax (Rac Cmax)
Time frame: From Day 1 (pre-dose) to Day 10 (48-hour post dose)
Parts 2 and 3B: Temporal Change Parameter (TCP)
Time frame: From Day 1 (pre-dose) to Day 10 (48-hour post dose)
Part 4: Number of participants with AEs and SAEs
Time frame: SAEs: From Screening (Day -28) to 6 weeks; AEs: From Day 1 to 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2025.
- Individual participant dataSharing planned: Yes. Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. "Yes", indicates that AZ are accepting requests for IPD, but this does not mean all requests will be approved.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AZD8965 in people with Healthy Participants, run by AstraZeneca at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Parts 1 and 3A: Number of participants with adverse events (AEs) and serious adverse events (SAEs) (time frame: SAEs: From Screening (Day -28) to 5 weeks; AEs: From Day 1 to 5 weeks). The study lists 18 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2025.