New drug AZD8965 put to the test in healthy volunteers
NCT ID NCT06502379
First seen Jun 27, 2026 ยท Last updated Jun 27, 2026
Summary
This early-stage study tested a new drug called AZD8965 in 147 healthy adults, including Japanese and Chinese participants. The main goal was to check if the drug is safe and how the body processes it, both with and without food. No treatment was given for any disease, so this study helps researchers understand the drug before testing it in patients.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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147 people
The number who actually took part.
- Started
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Aug 2024
- Finished
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Nov 2025
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 55 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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) 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: 1. 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. 2. Documentation of irreversible surgical sterilization by hysterectomy, bilateral oophorectomy, or bilateral salpingectomy. Tubal ligation is not acceptable. * 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: 1. Born in Japan 2. Have 2 Japanese biological parents and 4 Japanese grandparents. 3. 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: 1. Born in mainland China, Hong Kong, Macau, or Taiwan 2. Have 2 Chinese biological parents and 4 Chinese grandparents as confirmed by the interview. 3. Did not live outside China for more than 10 years at the time of Screening. Exclusion Criteria: * 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). * 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Research Site
Glendale, California, 91206, United States
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Other studies related to the condition(s) this trial covers.
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