A Study to Investigate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Immunogenicity of AZD1613 in Healthy Participants.

Launched by ASTRAZENECA · May 28, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called AZD1613 to see how safe it is and how well it works in healthy people. The researchers want to understand how the body processes this treatment and if it triggers any immune response. The trial is open to healthy men and women, particularly those of Japanese or Chinese descent, aged between 18 and 62 years. To qualify, participants must be in good health and meet certain criteria, such as having a suitable body weight and not having any major medical issues that could affect their participation.

If you join the study, you will be closely monitored to ensure your safety and to collect information about how AZD1613 affects your body. This includes regular check-ups and tests. It’s important to know that the study is not yet recruiting participants, so you will have to wait until it begins. Additionally, participants who smoke heavily or have a history of drug or alcohol abuse will not be eligible. Overall, this trial aims to gather important information that can help in the development of new treatments.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Healthy males and females of non-childbearing potential with suitable veins for cannulation or repeated venipuncture.
• • 2. Negative pregnancy test at screening and admission (females only).
• • 3. Females of non-childbearing potential confirmed by postmenopausal status or irreversible surgical sterilization.
• • 4. Sexually active fertile males must use contraception methods from first administration until 3 months after the last follow-up visit.
• • 5. Body mass index (BMI) between 18 and 32 kg/m² and weight at least 50 kg.
• • 6. Participants of Chinese descent (Part A2) must have both parents and four grandparents who are Chinese.
• • 7. Participants of Japanese descent (Part A3) must have both parents and four grandparents who are Japanese.
• Exclusion Criteria:
• • 1. The history of any clinically important disease or disorder may either put the participant at risk due to participation in the study, influence the results, or affect the participant's ability to participate in the study.
• • 2. History or presence of gastrointestinal, hepatic, or renal disease affecting drug absorption, distribution, metabolism, or excretion of drugs.
• • 3. Any clinically important illness, medical/surgical procedure, or trauma within 4 weeks of first administration.
• • 4. Abnormal lab values at screening or admission (e.g., alanine aminotransferase (ALT) \> upper limit normal (ULN), aspartate aminotransferase (AST) \> ULN, bilirubin \> 1.5 × ULN, estimated glomerular filtration rate (eGFR) \< 80 mL/min/1.73 m², hemoglobin \< lower limit normal \[LLN\]).
• • 5. Any clinically important abnormalities in clinical chemistry, hematology, or urinalysis results.
• • 6. Any positive result for serum Hepatitis B surface antigen (HBsAg), Hepatitis B core antibody (HBcAb), Hepatitis C virus antibody (HCV Ab) or Human immunodeficiency virus (HIV).
• • 7. Abnormal vital signs after 5 minutes supine rest at screening or admission (e.g., systolic BP \< 90 mmHg or ≥ 140 mmHg, diastolic BP \< 50 mmHg or ≥ 90 mmHg, heart rate \< 45 or \> 85 bpm).
• • 8. Any clinically important abnormalities in rhythm, conduction, or morphology of resting 12-lead Electrocardiogram (ECG) at screening or admission (e.g., prolonged QTcF \> 450 ms, shortened QTcF \< 340 ms, family history of long QT syndrome).
• • 9. Smokers who smoke more than 5 cigarettes per day and cannot adhere to no smoking during residential visits.
• • 10. Known or suspected history of alcohol or drug abuse or excessive alcohol intake.
• • 11. Positive screen for drugs of abuse or alcohol at screening or admission.
• • 12. History of severe allergy/hypersensitivity or ongoing clinically important allergy/hypersensitivity.
• • 13. Use of prescribed or nonprescribed medication including antacids, analgesics (other than paracetamol/acetaminophen), herbal remedies, or intake of \> 3 × daily recommended levels of vitamins and minerals during the 2 weeks prior to first administration.
• • 14. Plasma donation within one month of screening or any blood donation/blood loss \> 500 mL during the 3 months prior to screening.
• • 15. Received another new chemical entity within 30 days or 5 half-lives (whichever is longest) of first administration.
• • 16. Previously received AZD1613.
• • 17. Involvement in the planning and/or conduct of the study.
• • 18. Judgment by the Investigator that the participant should not participate due to minor medical complaints or non-compliance with study procedures.
• • 19. Medical dietary restrictions or inability/unwillingness to comply with meals provided during the stay at the Clinical Unit.
• • 20. Inability to communicate reliably with the Investigator.
• • 21. Vulnerable participants (e.g., kept in detention, protected adults under guardianship).