Healthy ParticipantsPhase 1NCT07290283
A Study to Investigate Safety, Tolerability, and Pharmacokinetics of AZD3974 in Healthy Participants
A Phase 1 study testing AZD3974 in people with Healthy Participants, run by AstraZeneca at 2 sites in United States.
Trial summary
The purpose of this study is to assess the safety and tolerability of AZD3974 and characterize the pharmacokinetics (PK) of AZD3974 following oral administration to healthy participants, including participants of Japanese and Chinese descent. 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?
- AZD3974
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 176 participants
- Where
- 2 sitesUnited States
- Study dates
- 10 Dec 2025to 8 Dec 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 (of non-childbearing potential) participants with suitable veins for cannulation or repeated venipuncture at the Screening Visit.
- All females must have a negative pregnancy test. Females of non-childbearing potential must be confirmed via post-menopausal status or documentation of irreversible surgical sterilization at the Screening Visit.
- Sexually active fertile male participants with partners of childbearing potential must adhere to the contraception methods.
- Have a body mass index between 18 and 32 kg/m2 inclusive and weigh at least 50 kg at Screening.
- For healthy Japanese cohorts (Part A2 and Part B2): healthy male and female participants are to be Japanese (eg, natives of Japan or Japan Americans), defined as having both parents and 4 grandparents who are Japanese. This includes second and third generation participants of Japanese descent whose parents or grandparents are living in a country other than Japan.
- For healthy Chinese cohort (Part A3): healthy male and female Chinese participants for whom both parents and 4 grandparents are Chinese. This includes second and third generation participants of Chinese descent whose parents or grandparents are living in a country other than China.
Who cannot join
- History of any clinically important disease or disorder which, may either put the participant at risk because of participation in the study, or influence the results or the participant's ability to participate in the study.
- History or presence of gastrointestinal, hepatic, or renal disease or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs.
- Any clinically important illness, medical/surgical procedure, or trauma within 4 weeks of the first administration of study intervention.
- Any abnormal laboratory values, vital signs, or any clinically important abnormalities in clinical chemistry, hematology, or urinalysis results.
- Any positive result on Screening for serum hepatitis B and C viruses and human immunodeficiency virus.
- Any clinically important abnormalities in rhythm, conduction, or morphology of the resting 12 lead electrocardiography at Screening and/or admission to the Clinical Unit .
Show all 10Show fewer
- Known or suspected history of alcohol or drug abuse or excessive intake of alcohol.
- Positive screen for drugs of abuse, or alcohol, or cotinine.
- History of severe allergy/hypersensitivity or ongoing clinically important allergy/hypersensitivity.
- Participants who have previously received AZD3974.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
AstraZeneca Clinical Study Information Center contact
United States2 sites, 2 recruiting
- Recruiting
Research Site
Baltimore, Maryland, 21225
- Recruiting
Research Site
Glendale, California, 91206
About this study
Official title: A Phase I, Randomized, Single-blind, Placebo-controlled Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD3974 After Single and Multiple Ascending Dosing to Healthy Participants
The purpose of this study is to assess the safety and tolerability of AZD3974 and characterize the pharmacokinetics (PK) of AZD3974 following oral administration to healthy participants, including participants of Japanese and Chinese descent.
Read the detailed description
This is a first in human, randomized, single-blind, placebo-controlled study. It consists of two parts.
Part A (single ascending dose - SAD): This study part will enroll six cohorts (plus two optional additional cohorts) of healthy participants (Part A1), three cohorts (plus one optional additional cohort) of healthy Japanese participants (Part A2) and one cohort (plus one optional additional cohort) of healthy Chinese participants (Part A3). Cohort 3 of Part A1 will be extended to evaluate the effect of food intake on the PK of AZD3974. In Part A (all cohorts), participants will receive a single dose of AZD3974 or placebo.
Part B (Multiple Ascending Dose - MAD): This study part will consist of four cohorts (plus two optional additional cohorts) of healthy participants (Part B1) and one cohort (plus one optional additional cohort) of healthy Japanese participants (Part B2). In all Part B cohorts, participants will receive multiple doses of AZD3974 or placebo.
Both Part A and Part B will comprise of:
- A Screening Period of maximum 28 days
- A Dosing session during which participants will receive the study intervention at study specific time points.
- Follow-up Period of 7 days post last-dose.
- Conditions
- Healthy Participants
- Being tested
- AZD3974, Placebo
- Keywords
- Single ascending dose, Multiple ascending dose, Pharmacokinetics, Impact of food, First-in-human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD3974Drug
AZD3974 will be administered as an oral solution.
PlaceboOther
Placebo will be administered as an oral solution.
| Study group | Role | What they receive |
|---|---|---|
| Part A1 (SAD) Cohort 1: AZD3974 (Dose 1) | Experimental | Healthy participants will receive a single dose of AZD3974 - Dose 1 Receives: Drug: AZD3974 |
| Part A1 (SAD) Cohort 2: AZD3974 (Dose 2) | Experimental | Healthy participants will receive a single dose of AZD3974 - Dose 2 Receives: Drug: AZD3974 |
| Part A1 (SAD) Cohort 3: AZD3974 (Dose 3) (Food Effect Cohort) | Experimental | Healthy participants will receive two single doses of AZD3974 - Dose 3 Receives: Drug: AZD3974 |
| Part A1 (SAD) Cohort 4: AZD3974 (Dose 4) | Experimental | Healthy participants will receive a single dose of AZD3974 - Dose 4 Receives: Drug: AZD3974 |
| Part A1 (SAD) Cohort 5: AZD3974 (Dose 5) | Experimental | Healthy participants will receive a single dose of AZD3974 - Dose 5 Receives: Drug: AZD3974 |
| Part A1 (SAD) Cohort 6: AZD3974 (Dose 6) | Experimental | Healthy participants will receive a single dose of AZD3974 - Dose 6 Receives: Drug: AZD3974 |
| Part A1 (SAD) optional additional Cohort 7: AZD3974 | Experimental | Healthy participants will receive a single dose of AZD3974 Receives: Drug: AZD3974 |
| Part A1 (SAD) optional additional Cohort 8: AZD3974 | Experimental | Healthy participants will receive a single dose of AZD3974 Receives: Drug: AZD3974 |
| Part A1 (SAD) Cohort: Placebo | Placebo comparator | Healthy participants will receive a single dose of matching placebo to AZD3974 Receives: Other: Placebo |
| Part A1 (SAD) Cohort 3: Placebo (Food Effect Cohort) | Placebo comparator | Healthy participants will receive two single doses of matching placebo to AZD3974 Receives: Other: Placebo |
| Part A2 (SAD) Japanese Cohort 1: AZD3974 | Experimental | Healthy Japanese participants will receive a single dose of AZD3974 Receives: Drug: AZD3974 |
| Part A2 (SAD) Japanese Cohort 2: AZD3974 | Experimental | Healthy Japanese participants will receive a single dose of AZD3974 Receives: Drug: AZD3974 |
| Part A2 (SAD) Japanese Cohort 3: AZD3974 | Experimental | Healthy Japanese participants will receive a single dose of AZD3974 Receives: Drug: AZD3974 |
| Part A2 (SAD) optional additional Japanese Cohort 4: AZD3974 | Experimental | Healthy Japanese participants will receive a single dose of AZD3974 Receives: Drug: AZD3974 |
| Part A2 (SAD) Japanese Cohort: Placebo | Placebo comparator | Healthy Japanese participants will receive a single dose of matching placebo to AZD3974 Receives: Other: Placebo |
| Part A3 (SAD) Chinese Cohort 1: AZD3974 | Experimental | Healthy Chinese participants will receive a single dose of AZD3974 Receives: Drug: AZD3974 |
| Part A3 (SAD) optional additional Chinese Cohort 2: AZD3974 | Experimental | Healthy Chinese participants will receive a single dose of AZD3974 Receives: Drug: AZD3974 |
| Part A3 (SAD) Chinese Cohort: Placebo | Placebo comparator | Healthy Chinese participants will receive a single dose of matching placebo to AZD3974 Receives: Other: Placebo |
| Part B1 (MAD) Cohort 1: AZD3974 | Experimental | Healthy participants will receive multiple doses of AZD3974 Receives: Drug: AZD3974 |
| Part B1 (MAD) Cohort 2: AZD3974 | Experimental | Healthy participants will receive multiple doses of AZD3974 Receives: Drug: AZD3974 |
| Part B1 (MAD) Cohort 3: AZD3974 | Experimental | Healthy participants will receive multiple doses of AZD3974 Receives: Drug: AZD3974 |
| Part B1 (MAD) Cohort 4: AZD3974 | Experimental | Healthy participants will receive multiple doses of AZD3974 Receives: Drug: AZD3974 |
| Part B1 (MAD) optional additional Cohort 5: AZD3974 | Experimental | Healthy participants will receive multiple doses of AZD3974 Receives: Drug: AZD3974 |
| Part B1 (MAD) optional additional Cohort 6: AZD3974 | Experimental | Healthy participants will receive multiple doses of AZD3974 Receives: Drug: AZD3974 |
| Part Bl (MAD) Cohort: Placebo | Placebo comparator | Healthy participants will receive multiple doses of matching placebo to AZD3974 Receives: Other: Placebo |
| Part B2 (MAD) Japanese Cohort 1: AZD3974 | Experimental | Healthy Japanese participants will receive multiple doses of AZD397 Receives: Drug: AZD3974 |
| Part B2 (MAD) optional additional Japanese Cohort 2: AZD3974 | Experimental | Healthy Japanese participants will receive multiple doses of matching placebo to AZD3974 Receives: Drug: AZD3974 |
| Part B2 (MAD) Japanese Cohort: Placebo | Placebo comparator | Healthy Japanese participants will receive multiple doses of matching placebo to AZD3974 Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with adverse events (AEs) and serious adverse events (SAEs)
To assess the safety and tolerability of AZD3974 following oral administration of single and multiple ascending doses in healthy participants, including Chinese and Japanese participants
Measured: Part A: Upto Day 7; Part A1 Cohort 3: Upto Day 10; Part B: Upto Day 14
Secondary outcomes (41)
Part A and Part B: Plasma concentrations of AZD3974
To characterize the plasma concentrations of AZD3974 following single and multiple ascending doses in healthy participants, including Chinese and Japanese participants.
Measured: Part A: Day 1 to Day 2; Part B: Day 1 to Day 9
Part A1-Cohort 3: Plasma concentrations of AZD3974
To assess the impact of food (fed) on the single-dose plasma concentrations of AZD3974
Measured: Day 1 to Day 4
Part A and Part B: Urine concentrations of AZD3974
To characterize the urine concentration of AZD3974 following single and multiple ascending doses in healthy participants, including Chinese and Japanese participants.
Measured: Part A: Day 1; Part B: Day 1 and Day 7
Part A1-Cohort 3: Urine concentrations of AZD3974
To assess the impact of food (fed) on the single-dose urine concentrations of AZD3974
Measured: Day 1 and Day 3
Part A and Part B: Area under concentration-curve from time 0 to the last quantifiable concentration (AUClast)
To characterize the PK of AZD3974 following single and multiple ascending doses in healthy participants, including Chinese and Japanese participants
Measured: Part A: Day 1 to Day 2; Part B: Day 1 to Day 9
Part A1-Cohort 3: Area under concentration-curve from time 0 to the last quantifiable concentration (AUClast)
To assess the impact of food (fed) on the single-dose PK of AZD3974
Measured: Day 1 to Day 4
Part A: Area under concentration-time curve from time 0 to infinity (AUCinf)
To characterize the PK of AZD3974 following single ascending doses in healthy participants, including Chinese and Japanese participants
Measured: Day 1 to Day 2
Part A1-Cohort 3: Area under concentration-time curve from time 0 to infinity (AUCinf)
To assess the impact of food (fed) on the single-dose PK of AZD3974
Measured: Day 1 to Day 4
Part A and Part B: Maximum observed drug concentration (Cmax)
To characterize the PK of AZD3974 following single and multiple ascending doses in healthy participants, including Chinese and Japanese participants
Measured: Part A: Day 1 to Day 2; Part B: Day 1 to Day 9
Part A1-Cohort 3: Maximum observed drug concentration (Cmax)
To assess the impact of food (fed) on the single-dose PK of AZD3974
Measured: Day 1 to Day 4
Part A and Part B: Time to reach maximum observed concentration (tmax)
To characterize the PK of AZD3974 following single and multiple ascending doses in healthy participants, including Chinese and Japanese participants
Measured: Part A: Day 1 to Day 2; Part B: Day 1 to Day 9
Part A1-Cohort 3: Time to reach maximum observed concentration (tmax)
To assess the impact of food (fed) on the single-dose PK of AZD3974
Measured: Day 1 to Day 4
Part A and Part B: Terminal elimination half-life (t½λz)
To characterize the PK of AZD3974 following single and multiple ascending doses in healthy participants, including Chinese and Japanese participants
Measured: Part A: Day 1 to Day 2; Part B: Day 1 to Day 9
Part A1-Cohort 3: Terminal elimination half-life (t½λz)
To assess the impact of food (fed) on the single-dose PK of AZD3974
Measured: Day 1 to Day 4
Part A and Part B: Apparent total body clearance (CL/F)
To characterize the PK of AZD3974 following single and multiple ascending doses in healthy participants, including Chinese and Japanese participants
Measured: Part A: Day 1 to Day 2; Part B: Day 1 to Day 9
Part A1-Cohort 3: Apparent total body clearance (CL/F)
To assess the impact of food (fed) on the single-dose PK of AZD3974
Measured: Day 1 to Day 4
Part A and Part B: Apparent volume of distribution based on the terminal phase (Vz/F)
To characterize the PK of AZD3974 following single and multiple ascending doses in healthy participants, including Chinese and Japanese participants
Measured: Part A: Day 1 to Day 2; Part B: Day 1 to Day 9
Part A1-Cohort 3: Apparent volume of distribution based on the terminal phase (Vz/F)
To assess the impact of food (fed) on the single-dose PK of AZD3974
Measured: Day 1 to Day 4
Part A and Part B: Individual and cumulative amount of unchanged drug excreted into urine from time t0 to time tlast [Ae(0-last)]
To characterize the PK of AZD3974 following single and multiple ascending doses in healthy participants, including Chinese and Japanese participants
Measured: Part A: Day 1; Part B: Day 1 and Day 7
Part A1-Cohort 3: Individual and cumulative amount of unchanged drug excreted into urine from time t0 to time tlast [Ae(0-last)]
To assess the impact of food (fed) on the single-dose PK of AZD3974
Measured: Day 1 and Day 3
Part A and Part B: Individual and cumulative percentage of dose excreted unchanged in urine from time t0 to tlast [fe(0-last)]
To characterize the PK of AZD3974 following single and multiple ascending doses in healthy participants, including Chinese and Japanese participants
Measured: Part A: Day 1; Part B: Day 1 and Day 7
Part A1-Cohort 3: Individual and cumulative percentage of dose excreted unchanged in urine from time t0 to tlast [fe(0-last)]
To assess the impact of food (fed) on the single-dose PK of AZD3974
Measured: Day 1 and Day 3
Part A and Part B: Renal clearance (CLR)
To characterize the PK of AZD3974 following single and multiple ascending doses in healthy participants, including Chinese and Japanese participants
Measured: Part A: Day 1; Part B: Day 1 and Day 7
Part A1-Cohort 3: Renal clearance (CLR)
To assess the impact of food (fed) on the single-dose PK of AZD3974
Measured: Day 1 and Day 3
Part A and Part B: Mean Residence Time (MRT)
To characterize the PK of AZD3974 following single and multiple ascending doses in healthy participants, including Chinese and Japanese participants.
Measured: Part A: Day 1 to Day 2; Part B: Day 1 to Day 9
Part A1-Cohort 3: Mean Residence Time (MRT)
To assess the impact of food (fed) on the single-dose PK of AZD3974
Measured: Day 1 to Day 4
Part A and Part B: Time delay between drug administration and the first observed concentration (tlag)
To characterize the PK of AZD3974 following single and multiple ascending doses in healthy participants, including Chinese and Japanese participants.
Measured: Part A: Day 1 to Day 2; Part B: Day 1 to Day 9
Part A1-Cohort 3: Time delay between drug administration and the first observed concentration (tlag)
To assess the impact of food (fed) on the single-dose PK of AZD3974
Measured: Day 1 to Day 4
Part A and Part B: Time of last quantifiable concentration (tlast)
To characterize the PK of AZD3974 following single and multiple ascending doses in healthy participants, including Chinese and Japanese participants.
Measured: Part A: Day 1 to Day 2; Part B: Day 1 to Day 9
Part A1-Cohort 3: Time of last quantifiable concentration (tlast)
To assess the impact of food (fed) on the single-dose PK of AZD3974
Measured: Day 1 to Day 4
Part A and Part B: Individual and cumulative amount of unchanged drug excreted into urine from time t1 to time t2 [Ae(t1 t2)]
To characterize the PK of AZD3974 following single and multiple ascending doses in healthy participants, including Chinese and Japanese participants.
Measured: Part A: Day 1; Part B: Day 1 and Day 7
Part A1-Cohort 3: Individual and cumulative amount of unchanged drug excreted into urine from time t1 to time t2 [Ae(t1 t2)]
To assess the impact of food (fed) on the single-dose PK of AZD3974
Measured: Day 1 and Day 3
Part A and Part B: Individual and cumulative percentage of dose excreted unchanged in urine from time t1 to time t2 - [fe(t1-t2)]
To characterize the PK of AZD3974 following single and multiple ascending doses in healthy participants, including Chinese and Japanese participants.
Measured: Part A: Day 1; Part B: Day 1 and Day 7
Part A1-Cohort 3: Individual and cumulative percentage of dose excreted unchanged in urine from time t1 to time t2 - [fe(t1-t2)]
To assess the impact of food (fed) on the single-dose PK of AZD3974
Measured: Day 1 and Day 3
Part A and Part B: Cumulative amount of unchanged drug excreted into urine (Aeinf)
To characterize the PK of AZD3974 following single and multiple ascending doses in healthy participants, including Chinese and Japanese participants.
Measured: Part A: Day 1; Part B : Day 1 and Day 7
Part A1-Cohort 3: Cumulative amount of unchanged drug excreted into urine (Aeinf)
To assess the impact of food (fed) on the single-dose PK of AZD3974
Measured: Day 1 and Day 3
Part B: Area under concentration time curve in the dosing interval (AUCtau)
To characterize the PK of AZD3974 following multiple ascending doses in healthy participants, including Japanese participants
Measured: Day 1 to Day 9
Part B: Observed lowest concentration before the next dose is administered: (Ctrough)
To characterize the PK of AZD3974 following multiple ascending doses in healthy participants, including Japanese participants.
Measured: Day 1 to Day 9
Part B: Accumulation ratio for AUC calculated as steady State AUCτ/First Dose AUCτ (Rac AUC)
To characterize the PK of AZD3974 following multiple ascending doses in healthy participants, including Japanese participants
Measured: Day 1 to Day 9
Part B: Accumulation ratio for Cmax calculated as steady State Cmax/First Dose Cmax (Rac Cmax)
To characterize the PK of AZD3974 following multiple ascending doses in healthy participants, including Japanese participants.
Measured: Day 1 to Day 9
Part B: Temporal change parameter calculated as steady State AUCτ/First Dose AUCinf (TCP)
To characterize the PK of AZD3974 following multiple ascending doses in healthy participants, including Japanese participants.
Measured: Day 1 to Day 9
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2025
- Study start10 Dec 2025
- Primary completion8 Dec 2026 (estimated)
- Study completion8 Dec 2026 (estimated)
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
- Single blind
- Who is masked
- Participant
- Enrolment
- 176 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Parexel
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07290283
- Sponsor's protocol ID
- D7360C00001
- Status last verified
- Oct 2026
- First submitted
- 5 Dec 2025
- Last updated
- 13 Oct 2026
- 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 shared.
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. 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 AZD3974 After Single and Multiple Ascending Dosing to Healthy Participants
- ClinicalTrials.gov ID
- NCT07290283
- Acronym / sponsor ID
- D7360C00001
- Conditions
- Healthy Participants
- Keywords
- Single ascending dose, Multiple ascending dose, Pharmacokinetics, Impact of food, First-in-human
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 176 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Collaborators
- Parexel
- Study start
- 10 Dec 2025 (actual)
- Primary completion
- 8 Dec 2026 (estimated)
- Study completion
- 8 Dec 2026 (estimated)
- First posted
- 18 Dec 2025 (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 and tolerability of AZD3974 and characterize the pharmacokinetics (PK) of AZD3974 following oral administration to healthy participants, including participants of Japanese and Chinese descent.
Detailed description
This is a first in human, randomized, single-blind, placebo-controlled study. It consists of two parts.
Part A (single ascending dose - SAD): This study part will enroll six cohorts (plus two optional additional cohorts) of healthy participants (Part A1), three cohorts (plus one optional additional cohort) of healthy Japanese participants (Part A2) and one cohort (plus one optional additional cohort) of healthy Chinese participants (Part A3). Cohort 3 of Part A1 will be extended to evaluate the effect of food intake on the PK of AZD3974. In Part A (all cohorts), participants will receive a single dose of AZD3974 or placebo.
Part B (Multiple Ascending Dose - MAD): This study part will consist of four cohorts (plus two optional additional cohorts) of healthy participants (Part B1) and one cohort (plus one optional additional cohort) of healthy Japanese participants (Part B2). In all Part B cohorts, participants will receive multiple doses of AZD3974 or placebo.
Both Part A and Part B will comprise of:
- A Screening Period of maximum 28 days
- A Dosing session during which participants will receive the study intervention at study specific time points.
- Follow-up Period of 7 days post last-dose.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (participant)
- Number of arms
- 28
| Arm | Type | Receives |
|---|---|---|
| Part A1 (SAD) Cohort 1: AZD3974 (Dose 1) | Experimental | Drug: AZD3974Healthy participants will receive a single dose of AZD3974 - Dose 1 |
| Part A1 (SAD) Cohort 2: AZD3974 (Dose 2) | Experimental | Drug: AZD3974Healthy participants will receive a single dose of AZD3974 - Dose 2 |
| Part A1 (SAD) Cohort 3: AZD3974 (Dose 3) (Food Effect Cohort) | Experimental | Drug: AZD3974Healthy participants will receive two single doses of AZD3974 - Dose 3 |
| Part A1 (SAD) Cohort 4: AZD3974 (Dose 4) | Experimental | Drug: AZD3974Healthy participants will receive a single dose of AZD3974 - Dose 4 |
| Part A1 (SAD) Cohort 5: AZD3974 (Dose 5) | Experimental | Drug: AZD3974Healthy participants will receive a single dose of AZD3974 - Dose 5 |
| Part A1 (SAD) Cohort 6: AZD3974 (Dose 6) | Experimental | Drug: AZD3974Healthy participants will receive a single dose of AZD3974 - Dose 6 |
| Part A1 (SAD) optional additional Cohort 7: AZD3974 | Experimental | Drug: AZD3974Healthy participants will receive a single dose of AZD3974 |
| Part A1 (SAD) optional additional Cohort 8: AZD3974 | Experimental | Drug: AZD3974Healthy participants will receive a single dose of AZD3974 |
| Part A1 (SAD) Cohort: Placebo | Placebo comparator | Other: PlaceboHealthy participants will receive a single dose of matching placebo to AZD3974 |
| Part A1 (SAD) Cohort 3: Placebo (Food Effect Cohort) | Placebo comparator | Other: PlaceboHealthy participants will receive two single doses of matching placebo to AZD3974 |
| Part A2 (SAD) Japanese Cohort 1: AZD3974 | Experimental | Drug: AZD3974Healthy Japanese participants will receive a single dose of AZD3974 |
| Part A2 (SAD) Japanese Cohort 2: AZD3974 | Experimental | Drug: AZD3974Healthy Japanese participants will receive a single dose of AZD3974 |
| Part A2 (SAD) Japanese Cohort 3: AZD3974 | Experimental | Drug: AZD3974Healthy Japanese participants will receive a single dose of AZD3974 |
| Part A2 (SAD) optional additional Japanese Cohort 4: AZD3974 | Experimental | Drug: AZD3974Healthy Japanese participants will receive a single dose of AZD3974 |
| Part A2 (SAD) Japanese Cohort: Placebo | Placebo comparator | Other: PlaceboHealthy Japanese participants will receive a single dose of matching placebo to AZD3974 |
| Part A3 (SAD) Chinese Cohort 1: AZD3974 | Experimental | Drug: AZD3974Healthy Chinese participants will receive a single dose of AZD3974 |
| Part A3 (SAD) optional additional Chinese Cohort 2: AZD3974 | Experimental | Drug: AZD3974Healthy Chinese participants will receive a single dose of AZD3974 |
| Part A3 (SAD) Chinese Cohort: Placebo | Placebo comparator | Other: PlaceboHealthy Chinese participants will receive a single dose of matching placebo to AZD3974 |
| Part B1 (MAD) Cohort 1: AZD3974 | Experimental | Drug: AZD3974Healthy participants will receive multiple doses of AZD3974 |
| Part B1 (MAD) Cohort 2: AZD3974 | Experimental | Drug: AZD3974Healthy participants will receive multiple doses of AZD3974 |
| Part B1 (MAD) Cohort 3: AZD3974 | Experimental | Drug: AZD3974Healthy participants will receive multiple doses of AZD3974 |
| Part B1 (MAD) Cohort 4: AZD3974 | Experimental | Drug: AZD3974Healthy participants will receive multiple doses of AZD3974 |
| Part B1 (MAD) optional additional Cohort 5: AZD3974 | Experimental | Drug: AZD3974Healthy participants will receive multiple doses of AZD3974 |
| Part B1 (MAD) optional additional Cohort 6: AZD3974 | Experimental | Drug: AZD3974Healthy participants will receive multiple doses of AZD3974 |
| Part Bl (MAD) Cohort: Placebo | Placebo comparator | Other: PlaceboHealthy participants will receive multiple doses of matching placebo to AZD3974 |
| Part B2 (MAD) Japanese Cohort 1: AZD3974 | Experimental | Drug: AZD3974Healthy Japanese participants will receive multiple doses of AZD397 |
| Part B2 (MAD) optional additional Japanese Cohort 2: AZD3974 | Experimental | Drug: AZD3974Healthy Japanese participants will receive multiple doses of matching placebo to AZD3974 |
| Part B2 (MAD) Japanese Cohort: Placebo | Placebo comparator | Other: PlaceboHealthy Japanese participants will receive multiple doses of matching placebo to AZD3974 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Healthy male and female (of non-childbearing potential) participants with suitable veins for cannulation or repeated venipuncture at the Screening Visit.
- All females must have a negative pregnancy test. Females of non-childbearing potential must be confirmed via post-menopausal status or documentation of irreversible surgical sterilization at the Screening Visit.
- Sexually active fertile male participants with partners of childbearing potential must adhere to the contraception methods.
- Have a body mass index between 18 and 32 kg/m2 inclusive and weigh at least 50 kg at Screening.
- For healthy Japanese cohorts (Part A2 and Part B2): healthy male and female participants are to be Japanese (eg, natives of Japan or Japan Americans), defined as having both parents and 4 grandparents who are Japanese. This includes second and third generation participants of Japanese descent whose parents or grandparents are living in a country other than Japan.
Key exclusion criteria (10 listed)
- History of any clinically important disease or disorder which, may either put the participant at risk because of participation in the study, or influence the results or the participant's ability to participate in the study.
- History or presence of gastrointestinal, hepatic, or renal disease or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs.
- Any clinically important illness, medical/surgical procedure, or trauma within 4 weeks of the first administration of study intervention.
- Any abnormal laboratory values, vital signs, or any clinically important abnormalities in clinical chemistry, hematology, or urinalysis results.
- Any positive result on Screening for serum hepatitis B and C viruses and human immunodeficiency virus.
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 |
|---|---|---|
| AZD3974AZD3974 will be administered as an oral solution. | Drug | Part A1 (SAD) Cohort 1: AZD3974 (Dose 1), Part A1 (SAD) Cohort 2: AZD3974 (Dose 2), Part A1 (SAD) Cohort 3: AZD3974 (Dose 3) (Food Effect Cohort), Part A1 (SAD) Cohort 4: AZD3974 (Dose 4), Part A1 (SAD) Cohort 5: AZD3974 (Dose 5), Part A1 (SAD) Cohort 6: AZD3974 (Dose 6), Part A1 (SAD) optional additional Cohort 7: AZD3974, Part A1 (SAD) optional additional Cohort 8: AZD3974, Part A2 (SAD) Japanese Cohort 1: AZD3974, Part A2 (SAD) Japanese Cohort 2: AZD3974, Part A2 (SAD) Japanese Cohort 3: AZD3974, Part A2 (SAD) optional additional Japanese Cohort 4: AZD3974, Part A3 (SAD) Chinese Cohort 1: AZD3974, Part A3 (SAD) optional additional Chinese Cohort 2: AZD3974, Part B1 (MAD) Cohort 1: AZD3974, Part B1 (MAD) Cohort 2: AZD3974, Part B1 (MAD) Cohort 3: AZD3974, Part B1 (MAD) Cohort 4: AZD3974, Part B1 (MAD) optional additional Cohort 5: AZD3974, Part B1 (MAD) optional additional Cohort 6: AZD3974, Part B2 (MAD) Japanese Cohort 1: AZD3974, Part B2 (MAD) optional additional Japanese Cohort 2: AZD3974 |
| PlaceboPlacebo will be administered as an oral solution. | Other | Part A1 (SAD) Cohort 3: Placebo (Food Effect Cohort), Part A1 (SAD) Cohort: Placebo, Part A2 (SAD) Japanese Cohort: Placebo, Part A3 (SAD) Chinese Cohort: Placebo, Part B2 (MAD) Japanese Cohort: Placebo, Part Bl (MAD) Cohort: Placebo |
Primary outcome
Number of participants with adverse events (AEs) and serious adverse events (SAEs)
Time frame: Part A: Upto Day 7; Part A1 Cohort 3: Upto Day 10; Part B: Upto Day 14
To assess the safety and tolerability of AZD3974 following oral administration of single and multiple ascending doses in healthy participants, including Chinese and Japanese participants
41 secondary outcomes
Part A and Part B: Plasma concentrations of AZD3974
Time frame: Part A: Day 1 to Day 2; Part B: Day 1 to Day 9
Part A1-Cohort 3: Plasma concentrations of AZD3974
Time frame: Day 1 to Day 4
Part A and Part B: Urine concentrations of AZD3974
Time frame: Part A: Day 1; Part B: Day 1 and Day 7
Part A1-Cohort 3: Urine concentrations of AZD3974
Time frame: Day 1 and Day 3
Part A and Part B: Area under concentration-curve from time 0 to the last quantifiable concentration (AUClast)
Time frame: Part A: Day 1 to Day 2; Part B: Day 1 to Day 9
Part A1-Cohort 3: Area under concentration-curve from time 0 to the last quantifiable concentration (AUClast)
Time frame: Day 1 to Day 4
Part A: Area under concentration-time curve from time 0 to infinity (AUCinf)
Time frame: Day 1 to Day 2
Part A1-Cohort 3: Area under concentration-time curve from time 0 to infinity (AUCinf)
Time frame: Day 1 to Day 4
Part A and Part B: Maximum observed drug concentration (Cmax)
Time frame: Part A: Day 1 to Day 2; Part B: Day 1 to Day 9
Part A1-Cohort 3: Maximum observed drug concentration (Cmax)
Time frame: Day 1 to Day 4
Part A and Part B: Time to reach maximum observed concentration (tmax)
Time frame: Part A: Day 1 to Day 2; Part B: Day 1 to Day 9
Part A1-Cohort 3: Time to reach maximum observed concentration (tmax)
Time frame: Day 1 to Day 4
Part A and Part B: Terminal elimination half-life (t½λz)
Time frame: Part A: Day 1 to Day 2; Part B: Day 1 to Day 9
Part A1-Cohort 3: Terminal elimination half-life (t½λz)
Time frame: Day 1 to Day 4
Part A and Part B: Apparent total body clearance (CL/F)
Time frame: Part A: Day 1 to Day 2; Part B: Day 1 to Day 9
Part A1-Cohort 3: Apparent total body clearance (CL/F)
Time frame: Day 1 to Day 4
Part A and Part B: Apparent volume of distribution based on the terminal phase (Vz/F)
Time frame: Part A: Day 1 to Day 2; Part B: Day 1 to Day 9
Part A1-Cohort 3: Apparent volume of distribution based on the terminal phase (Vz/F)
Time frame: Day 1 to Day 4
Part A and Part B: Individual and cumulative amount of unchanged drug excreted into urine from time t0 to time tlast [Ae(0-last)]
Time frame: Part A: Day 1; Part B: Day 1 and Day 7
Part A1-Cohort 3: Individual and cumulative amount of unchanged drug excreted into urine from time t0 to time tlast [Ae(0-last)]
Time frame: Day 1 and Day 3
Part A and Part B: Individual and cumulative percentage of dose excreted unchanged in urine from time t0 to tlast [fe(0-last)]
Time frame: Part A: Day 1; Part B: Day 1 and Day 7
Part A1-Cohort 3: Individual and cumulative percentage of dose excreted unchanged in urine from time t0 to tlast [fe(0-last)]
Time frame: Day 1 and Day 3
Part A and Part B: Renal clearance (CLR)
Time frame: Part A: Day 1; Part B: Day 1 and Day 7
Part A1-Cohort 3: Renal clearance (CLR)
Time frame: Day 1 and Day 3
Part A and Part B: Mean Residence Time (MRT)
Time frame: Part A: Day 1 to Day 2; Part B: Day 1 to Day 9
Part A1-Cohort 3: Mean Residence Time (MRT)
Time frame: Day 1 to Day 4
Part A and Part B: Time delay between drug administration and the first observed concentration (tlag)
Time frame: Part A: Day 1 to Day 2; Part B: Day 1 to Day 9
Part A1-Cohort 3: Time delay between drug administration and the first observed concentration (tlag)
Time frame: Day 1 to Day 4
Part A and Part B: Time of last quantifiable concentration (tlast)
Time frame: Part A: Day 1 to Day 2; Part B: Day 1 to Day 9
Part A1-Cohort 3: Time of last quantifiable concentration (tlast)
Time frame: Day 1 to Day 4
Part A and Part B: Individual and cumulative amount of unchanged drug excreted into urine from time t1 to time t2 [Ae(t1 t2)]
Time frame: Part A: Day 1; Part B: Day 1 and Day 7
Part A1-Cohort 3: Individual and cumulative amount of unchanged drug excreted into urine from time t1 to time t2 [Ae(t1 t2)]
Time frame: Day 1 and Day 3
Part A and Part B: Individual and cumulative percentage of dose excreted unchanged in urine from time t1 to time t2 - [fe(t1-t2)]
Time frame: Part A: Day 1; Part B: Day 1 and Day 7
Part A1-Cohort 3: Individual and cumulative percentage of dose excreted unchanged in urine from time t1 to time t2 - [fe(t1-t2)]
Time frame: Day 1 and Day 3
Part A and Part B: Cumulative amount of unchanged drug excreted into urine (Aeinf)
Time frame: Part A: Day 1; Part B : Day 1 and Day 7
Part A1-Cohort 3: Cumulative amount of unchanged drug excreted into urine (Aeinf)
Time frame: Day 1 and Day 3
Part B: Area under concentration time curve in the dosing interval (AUCtau)
Time frame: Day 1 to Day 9
Part B: Observed lowest concentration before the next dose is administered: (Ctrough)
Time frame: Day 1 to Day 9
Part B: Accumulation ratio for AUC calculated as steady State AUCτ/First Dose AUCτ (Rac AUC)
Time frame: Day 1 to Day 9
Part B: Accumulation ratio for Cmax calculated as steady State Cmax/First Dose Cmax (Rac Cmax)
Time frame: Day 1 to Day 9
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- 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 shared.
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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.
AstraZeneca Clinical Study Information Center contact
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AZD3974 in people with Healthy Participants, run by AstraZeneca at 2 sites 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 6 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: looking for participants now, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact AstraZeneca Clinical Study Information Center (1-877-240-9479, information.center@astrazeneca.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with adverse events (AEs) and serious adverse events (SAEs) (time frame: Part A: Upto Day 7; Part A1 Cohort 3: Upto Day 10; Part B: Upto Day 14). 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 13 Oct 2026.