A study to investigate safety, tolerability, pharmacokinetics, pharmacodynamics and immunogenicity of AZD1613 in healthy participants.

Study identifier:D9050C00001

ClinicalTrials.gov identifier:NCT06995820

EudraCT identifier:N/A

CTIS identifier:N/A

Recruiting

Official Title

A Phase I Randomized, Single-blind, Placebo-controlled Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of AZD1613 Following Single and Multiple Dose Administration in Healthy Participants

Medical condition

Healthy

Phase

Phase 1

Healthy volunteers

Yes

Study drug

AZD1613, Placebo

Sex

All

Estimated Enrollment

136

Study type

Interventional

Age

18 Years - 50 Years

Date

Study Start Date: 06 Jun 2025

Estimated Primary Completion Date: 12 Oct 2026

Estimated Study Completion Date: 12 Oct 2026

Study design

Allocation: Randomized
Endpoint Classification: -
Intervention Model: Sequential Assignment
Masking: -
Primary Purpose: Treatment

Verification:

Verified 01 Jun 2025 by AstraZeneca

Collaborators

PAREXEL

Inclusion and exclusion 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).

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Arms	Assigned Interventions
Experimental: Part A1 (SAD): AZD1613 (Dose 1) SC Participants will receive a single dose of AZD1613 (Dose 1) or matching placebo to AZD1613 as SC injection on Day 1.	Drug: AZD1613 AZD1613 will be administered as either SC injection or IV infusion on Day 1 in Part A and on Days 1, 29 and 57 in Part B of the study. Drug: Placebo Placebo will be administered as either SC injection or IV infusion on Day 1 in Part A and Days 1, 29 and 57 in Part B fo the study.
Experimental: Part A1 (SAD): AZD1613 (Dose 2) SC Participants will receive a single dose of AZD1613 (Dose 2) or matching placebo to AZD1613 as SC injection on Day 1.	Drug: AZD1613 AZD1613 will be administered as either SC injection or IV infusion on Day 1 in Part A and on Days 1, 29 and 57 in Part B of the study. Drug: Placebo Placebo will be administered as either SC injection or IV infusion on Day 1 in Part A and Days 1, 29 and 57 in Part B fo the study.
Experimental: Part A1 (SAD): AZD1613 (Dose 3) SC Participants will receive a single dose of AZD1613 (Dose 3) or matching placebo to AZD1613 as SC injection on Day 1.	Drug: AZD1613 AZD1613 will be administered as either SC injection or IV infusion on Day 1 in Part A and on Days 1, 29 and 57 in Part B of the study. Drug: Placebo Placebo will be administered as either SC injection or IV infusion on Day 1 in Part A and Days 1, 29 and 57 in Part B fo the study.
Experimental: Part A1 (SAD): AZD1613 (Dose 4) SC Participants will receive a single dose of AZD1613 (Dose 4) or matching placebo to AZD1613 as SC injection on Day 1.	Drug: AZD1613 AZD1613 will be administered as either SC injection or IV infusion on Day 1 in Part A and on Days 1, 29 and 57 in Part B of the study. Drug: Placebo Placebo will be administered as either SC injection or IV infusion on Day 1 in Part A and Days 1, 29 and 57 in Part B fo the study.
Experimental: Part A1 (SAD): AZD1613 (Dose 5) IV Participants will receive a single dose of AZD1613 (Dose 5) or matching placebo to AZD1613 as an IV infusion on Day 1.	Drug: AZD1613 AZD1613 will be administered as either SC injection or IV infusion on Day 1 in Part A and on Days 1, 29 and 57 in Part B of the study. Drug: Placebo Placebo will be administered as either SC injection or IV infusion on Day 1 in Part A and Days 1, 29 and 57 in Part B fo the study.
Experimental: Part A1 (SAD): AZD1613 (Dose 6) IV Participants will receive a single dose of AZD1613 (Dose 6) or matching placebo to AZD1613 as an IV infusion on Day 1.	Drug: AZD1613 AZD1613 will be administered as either SC injection or IV infusion on Day 1 in Part A and on Days 1, 29 and 57 in Part B of the study. Drug: Placebo Placebo will be administered as either SC injection or IV infusion on Day 1 in Part A and Days 1, 29 and 57 in Part B fo the study.
Experimental: Part A2 (SAD): AZD1613 (Dose 7) SC or IV (Chinese) Chinese participants will receive a single dose of AZD1613 (Dose 7) or matching placebo to AZD1613 as SC injection or IV infusion on Day 1.	Drug: AZD1613 AZD1613 will be administered as either SC injection or IV infusion on Day 1 in Part A and on Days 1, 29 and 57 in Part B of the study. Drug: Placebo Placebo will be administered as either SC injection or IV infusion on Day 1 in Part A and Days 1, 29 and 57 in Part B fo the study.
Experimental: Part A3 (SAD): AZD1613 (Dose 8) SC or IV (Japanese) Japanese participants will receive a single dose of AZD1613 (Dose 8) or matching placebo to AZD1613 as SC injection or IV infusion on Day 1.	Drug: AZD1613 AZD1613 will be administered as either SC injection or IV infusion on Day 1 in Part A and on Days 1, 29 and 57 in Part B of the study. Drug: Placebo Placebo will be administered as either SC injection or IV infusion on Day 1 in Part A and Days 1, 29 and 57 in Part B fo the study.
Experimental: Part A3 (SAD): AZD1613 (Dose 9) SC or IV (Japanese) Japanese participants will receive a single dose of AZD1613 (Dose 9) or matching placebo to AZD1613 as SC injection or IV infusion on Day 1.	Drug: AZD1613 AZD1613 will be administered as either SC injection or IV infusion on Day 1 in Part A and on Days 1, 29 and 57 in Part B of the study. Drug: Placebo Placebo will be administered as either SC injection or IV infusion on Day 1 in Part A and Days 1, 29 and 57 in Part B fo the study.
Experimental: Part B (MAD): AZD1613 (Dose 10) SC Participants will receive multiple doses of AZD1613 (Dose 10) or matching placebo to AZD1613 as SC injection or IV infusion on Days 1, 29 and 57.	Drug: AZD1613 AZD1613 will be administered as either SC injection or IV infusion on Day 1 in Part A and on Days 1, 29 and 57 in Part B of the study. Drug: Placebo Placebo will be administered as either SC injection or IV infusion on Day 1 in Part A and Days 1, 29 and 57 in Part B fo the study.
Experimental: Part B (MAD): AZD1613 (Dose 11) SC Participants will receive multiple doses of AZD1613 (Dose 11) or matching placebo to AZD1613 as SC injection or IV infusion on Days 1, 29 and 57.	Drug: AZD1613 AZD1613 will be administered as either SC injection or IV infusion on Day 1 in Part A and on Days 1, 29 and 57 in Part B of the study. Drug: Placebo Placebo will be administered as either SC injection or IV infusion on Day 1 in Part A and Days 1, 29 and 57 in Part B fo the study.
Experimental: Part B (MAD): AZD1613 (Dose 12) IV Participants will receive multiple doses of AZD1613 (Dose 12) or matching placebo to AZD1613 as an IV infusion on Days 1, 29 and 57.	Drug: AZD1613 AZD1613 will be administered as either SC injection or IV infusion on Day 1 in Part A and on Days 1, 29 and 57 in Part B of the study. Drug: Placebo Placebo will be administered as either SC injection or IV infusion on Day 1 in Part A and Days 1, 29 and 57 in Part B fo the study.

Documents available

Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Clinical Study Information Center

1-877-240-9479

[email protected]