A Study to Assess the Safety and Tolerability of Single Doses of AZD4076 in Healthy Male Subjects

This is a Phase 1, randomized, first-in-human (FIH) study to assess the safety, tolerability,
and pharmacokinetics (PK) of AZD4076 tetracosasodium following subcutaneous (SC)
administration in healthy male subjects at increasing single doses

Inclusion Criteria:

1. Provision of signed and dated, written informed consent prior to any study specific
procedures

2. Healthy male subjects aged 18 - 50 years with suitable veins for cannulation or
repeated venipuncture

3. Have a body mass index (BMI) between 18 and 30 kg/m2 inclusive and weigh at least 50
kg and no more than 100 kg inclusive

4. Provision of signed, written and dated informed consent for optional genetic research

Exclusion Criteria:

1. History or presence of any clinically significant disease or disorder which, in the
opinion of the Investigator, may either put the subject at risk because of
participation in the study, or influence the results or the subject's ability to
participate in the study

2. History or presence of hepatic or renal disease, or any other condition known to
interfere with distribution, metabolism, or excretion of drugs

3. History or presence of significant neurological or psychiatric disease/mental illness
(as judged by the investigator)

4. Suspicion of or known Gilbert's syndrome based on liver function tests

5. Any clinically significant illness, medical/surgical procedure, or trauma within 4
weeks of the administration of IMP

6. Any clinically significant abnormalities in clinical chemistry, hematology, or
urinalysis results, as judged by the investigator

7. Any positive result on screening for serum hepatitis B surface antigen (HBsAg),
hepatitis C antibody and human immunodeficiency virus (HIV)

8. Serum Creatinine greater than the ULN.

9. Platelet count outside the normal range.

10. AST, ALT, or GGT greater than the ULN.

11. Abnormal vital signs, after 10 minutes supine rest, defined as any of the following:

- Systolic BP (SBP) < 90mmHg or ≥ 140 mmHg

- Diastolic BP (DBP) < 50mmHg or ≥ 90 mmHg

- Pulse < 45 or > 85 beats per minute (bpm)

12. Any clinically significant abnormalities in rhythm, conduction or morphology of the
resting ECG and any clinically significant abnormalities in the 12-lead ECG, as
considered by the investigator that 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

13. Prolonged QTcF > 450 ms or shortened QTcF < 340 ms or family history of long QT
syndrome

14. PR(PQ) interval shortening < 120 ms (PR > 110 ms but < 120 ms is acceptable if there
is no evidence of ventricular pre-excitation)

15. PR (PQ) interval prolongation (> 240 ms) intermittent second (Wenckebach block while
asleep is not exclusive) or third degree AV block, or AV dissociation

16. Persistent or intermittent complete bundle branch block (BBB), incomplete bundle
branch block (IBBB), or intraventricular conduction delay (IVCD) with QRS > 110 ms.
Subjects with QRS > 110 ms but < 115 ms are acceptable if there is no evidence of, for
example, ventricular hypertrophy or pre-excitation

17. Known or suspected history of drug abuse, as judged by the investigator

18. Current smokers or those who have smoked or used nicotine products within the 3 months
prior to screening

19. History of alcohol abuse or excessive intake of alcohol, as judged by the investigator

20. Positive screen for drugs of abuse or cotinine (nicotine) at screening or admission to
the unit or positive screen for alcohol on admission to the unit prior to the
administration of IMP

21. History of severe allergy/hypersensitivity or ongoing clinically significant
allergy/hypersensitivity, as judged by the investigator or history of hypersensitivity
to drugs with a similar chemical structure or class to AZD4076 tetracosasodium

22. Excessive intake of caffeine containing drinks or food (e.g., coffee, tea), as judged
by the investigator

23. Use of drugs with enzyme inducing properties such as St John's Wort within 3 weeks
prior to the administration of IMP

24. Use of any prescribed or non-prescribed medication including antacids, analgesics
(other than paracetamol/acetaminophen), herbal remedies, megadose vitamins (intake of
20 to 600 times the recommended daily dose) and minerals during the two weeks prior to
the administration of IMP or longer if the medication has a long half-life

25. Plasma donation within one month of screening or any blood donation/blood loss > 500
mL during the 3 months prior to screening

26. Has received another new chemical entity (defined as a compound which has not been
approved for marketing) within 3 months of the administration of IMP in this study.
The period of exclusion begins three months after the final dose or one month after
the last visit whichever is the longest.

Note: Subjects consented and screened, but not randomized in this study or a previous
phase I study, are not excluded.

27. Vulnerable subjects, e.g., kept in detention, protected adults under guardianship,
trusteeship, or committed to an institution by governmental or juridical order

28. Involvement of any Astra Zeneca, PAREXEL or study site employee or their close
relatives

29. Judgment by the investigator that the subject should not participate in the study if
they have any ongoing or recent (i.e., during the screening period) minor medical
complaints that may interfere with the interpretation of study data or are considered
unlikely to comply with study procedures, restrictions and requirements

30. Subjects who are vegans or have medical dietary restrictions

31. Subjects who cannot communicate reliably with the investigator

In addition, any of the following is regarded as a criterion for exclusion from the
genetic research:

32. Previous bone marrow transplant

33. Non-leukocyte depleted whole blood transfusion within 120 days of the date of the
genetic sample collection