Recruiting
Phase 1

AZD1613

Sponsor:

AstraZeneca

Code:

NCT06995820

Conditions

Healthy

Eligibility Criteria

Sex: All

Age: 18 - 50

Healthy Volunteers: Accepted

Interventions

AZD1613

Placebo

Study Details

Brief summary:

The purpose of the study is to assess the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of AZD1613 in healthy participants, including Japanese and Chinese descent.

Conditions

Healthy

Study ID

NCT06995820

Start date

Jun 6, 2025

Status verified date

May, 2026

Completion date

Sep 23, 2026

Anticipated

Primary completion date

Sep 23, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 50

Healthy Volunteers: Accepted

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).

Study Design

Enrollment

136 participants

Anticipated

Allocation

Randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

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.

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.

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.

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.

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.

experimental: Part A1 (SAD): AZD1613 (Dose 7) IV

Participants will receive a single dose of AZD1613 (Dose 7) or matching placebo to AZD1613 as an IV infusion on Day 1.

experimental: Part A2 (SAD): AZD1613 (Dose 8) IV (Chinese)

Chinese participants will receive a single dose of AZD1613 (Dose 8) or matching placebo to AZD1613 as an IV infusion on Day 1.

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.

experimental: Part A3 (SAD): AZD1613 (Dose 10) SC or IV (Japanese)

Japanese participants will receive a single dose of AZD1613 (Dose 10) or matching placebo to AZD1613 as SC injection or IV infusion on Day 1.

experimental: Part B (MAD): AZD1613 (Dose 11) SC or IV

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.

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.

experimental: Part B (MAD): AZD1613 (Dose 13) IV

Participants will receive multiple doses of AZD1613 (Dose 13) or matching placebo to AZD1613 as an IV infusion on Days 1, 29 and 57.

Interventions

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.

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 of the study.

Primary outcome measure

  • Number of participants with adverse events (AEs) and serious AEs. [ Time Frame: AEs: Part A: From Day 1 to Final Follow-up (Day 105); Part B: From Day 1 to Final Follow-up (Day 161); SAEs: Part A: From Screening (Day -28 to Day -2) to Final Follow-up visit (Day 105) Part B: From Screening (Day -28) to Final Follow-up visit (Day 161) ]

Central Contacts and Locations

Central contacts

AstraZeneca Clinical Study Information Center

1-877-240-9479information.center@astrazeneca.com

Locations

Research Site

Recruiting

Glendale, California, United States, 91206

More Information

Sponsor

AstraZeneca

Last update posted

May 15, 2026

Last verified

May, 2026

Keywords

  • Pharmacokinetics
  • Single ascending dose
  • Multiple ascending dose

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by AstraZeneca on 2026-05-15.