A Safety Study of AZD4041 in Healthy Participants

Inclusion Criteria

• Provision of signed and dated written informed consent form prior to any study specific procedures
• Stated willingness to comply with all study procedures and availability for the duration of the study
• Healthy adult male or female participants. Female participants must be of non-childbearing potential (postmenopausal and/or surgically sterile)
• If female, meets one of the following criteria:
• Physiological postmenopausal status, defined as the following:
• absence of menses for at least 12 months following cessation of all exogenous hormonal treatments (without an alternative medical condition) at Screening and prior to the first study drug administration; and
• follicle stimulating hormone (FSH) levels ≥ 40 mIU/mL at Screening; and
• must have a negative pregnancy test result at screening and check-in. and/or
• Surgical sterile, defined as those who have had:

hysterectomy, bilateral oophorectomy and/or bilateral salpingectomy, or bilateral tubal ligation. Women who are surgically sterile must provide documentation of the procedure by an operative report, ultrasound, or other verifiable documentation; and must have a negative pregnancy test result at screening and check-in.

If postmenopausal and has an FSH of 21 units/week or > 3 units/day for men; > 14 units/week or > 2 units/day for women; intake of excessive alcohol, acute or chronic)

• History of any significant psychiatric disorder according to the criteria of the Diagnostic and Statistical manual of Mental Disorders, 5th Edition (DSM-5, American Psychiatric Association 2013) which, in the opinion of the Investigator, could be detrimental to participant safety or could compromise study data interpretation.
• History of substance use disorder, other than nicotine or caffeine (as per DSM-5 criteria)
• Use of any prescription drugs, including hormone replacement therapy in the 28 days prior to the first study drug administration, that in the opinion of an Investigator would put into question the status of the participant as healthy
• Use of St. John's wort in the 28 days prior to the first study drug administration
• Positive test result for alcohol and/or drugs of abuse at Screening or prior to the first study drug administration
• Any clinically significant illness, medical/surgical procedure or trauma within the 28 days prior to the first study drug administration
• Any abnormal or clinically significant findings in laboratory test results at Screening that would, in the opinion of an Investigator, increase the participant's risk of participation, jeopardize complete participation in the study, or compromise interpretation of study data
• Positive screening results to human immunodeficiency virus (HIV) antigen/antibody (Ag/Ab) combo, hepatitis B surface antigen, or hepatitis C virus tests
• Showing suicidal tendency as per the C-SSRS questionnaire administered at Screening
• Any abnormal vital signs, after 10 minutes supine rest, as defined in the list below, at the Screening Visit/or Day -2 Out of range tests may be repeated once for each visit at the discretion of an Investigator.
• Systolic blood pressure (BP) 140 mmHg
• Diastolic BP 90 mmHg
• Heart Rate 85 beats per minute (bpm)
• Any clinically important abnormalities in rhythm, conduction, or morphology of the resting ECG and any clinically important abnormalities in the 12-lead ECG which, in an Investigator's opinion, may interfere with the interpretation of QTc interval changes, including abnormal ST-T-wave morphology, particularly in the protocol-defined primary lead or left ventricular hypertrophy at Screening or prior to the first study drug administration
• Prolonged QT interval corrected for HR using Fridericia's formula (QTcF) > 440 ms at Screening or prior to the first study drug administration
• Shortened QTcF 110 ms but 220 ms), persistent or intermittent second (Wenckebach block while asleep is not exclusive), or third degree atrioventricular (AV) block, or AV diss