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

NCT06995820 | Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: D9050C00001
• Study Type: interventional
• Target: 136
• Locations: 1 country
• Sites: 1

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

Keywords

Pharmacokinetics; Single ascending dose; Multiple ascending dose

Outcome Measures

Primary Outcomes (1)

• Number of participants with adverse events (AEs) and serious AEs.

  To assess the safety and tolerability of AZD1613 following SC and/or IV administration of single and multiple ascending doses.

  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)

Secondary Outcomes (5)

• Area under concentration-time curve from time 0 to infinity (AUCinf) (Day 1 only)

  Part A: From Day 1 (pre-dose) to Day 105; Part B: From Day 1 (pre-dose) to Day 141

• Area under concentration-time curve from time 0 to the last quantifiable concentration (AUClast)

  Part A: From Day 1 (pre-dose) to Day 105; Part B: From Day 1 (pre-dose) to Day 141

• Maximum observed drug concentration (Cmax)

  Part A: From Day 1 (pre-dose) to Day 105; Part B: From Day 1 (pre-dose) to Day 141

• Incidence of positive anti-drug antibodies (ADAs) against AZD1613 in serum

  Part A: Day 1 (pre-dose), Day 29, Day 57 and Day 105; Part B: Day 1 (pre-dose), Day 29 (pre-dose), Day 57 (pre-dose), Day 85 and Day 161

• Change from baseline in study-specific biomarker ABC

  Part A: From Day 1 to Day 105; Part B: From Day -1 to Day 161

Study Arms (13)

Part A1 (SAD): AZD1613 (Dose 1) SC

EXPERIMENTAL

Participants will receive a single dose of AZD1613 (Dose 1) or matching placebo to AZD1613 as SC injection on Day 1.

Drug: AZD1613; Drug: Placebo

Part A1 (SAD): AZD1613 (Dose 2) SC

EXPERIMENTAL

Participants will receive a single dose of AZD1613 (Dose 2) or matching placebo to AZD1613 as SC injection on Day 1.

Drug: AZD1613; Drug: Placebo

Part A1 (SAD): AZD1613 (Dose 3) SC

EXPERIMENTAL

Participants will receive a single dose of AZD1613 (Dose 3) or matching placebo to AZD1613 as SC injection on Day 1.

Drug: AZD1613; Drug: Placebo

Part A1 (SAD): AZD1613 (Dose 4) SC

EXPERIMENTAL

Participants will receive a single dose of AZD1613 (Dose 4) or matching placebo to AZD1613 as SC injection on Day 1.

Drug: AZD1613; Drug: Placebo

Part A1 (SAD): AZD1613 (Dose 5) IV

EXPERIMENTAL

Participants will receive a single dose of AZD1613 (Dose 5) or matching placebo to AZD1613 as an IV infusion on Day 1.

Drug: AZD1613; Drug: Placebo

Part A1 (SAD): AZD1613 (Dose 6) IV

EXPERIMENTAL

Participants will receive a single dose of AZD1613 (Dose 6) or matching placebo to AZD1613 as an IV infusion on Day 1.

Drug: AZD1613; Drug: Placebo

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

EXPERIMENTAL

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

Drug: AZD1613; Drug: Placebo

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

EXPERIMENTAL

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

Drug: AZD1613; Drug: Placebo

Part A3 (SAD): AZD1613 (Dose 9) SC or IV (Japanese)

EXPERIMENTAL

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; Drug: Placebo

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

EXPERIMENTAL

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.

Drug: AZD1613; Drug: Placebo

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

EXPERIMENTAL

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; Drug: Placebo

Part B (MAD): AZD1613 (Dose 12) IV

EXPERIMENTAL

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; Drug: Placebo

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

EXPERIMENTAL

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

Drug: AZD1613; Drug: Placebo

Interventions

AZD1613 DRUG

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.

Part A1 (SAD): AZD1613 (Dose 1) SC; Part A1 (SAD): AZD1613 (Dose 2) SC; Part A1 (SAD): AZD1613 (Dose 3) SC; Part A1 (SAD): AZD1613 (Dose 4) SC; Part A1 (SAD): AZD1613 (Dose 5) IV; Part A1 (SAD): AZD1613 (Dose 6) IV; Part A1 (SAD): AZD1613 (Dose 7) IV; Part A2 (SAD): AZD1613 (Dose 8) IV (Chinese); Part A3 (SAD): AZD1613 (Dose 10) SC or IV (Japanese); Part A3 (SAD): AZD1613 (Dose 9) SC or IV (Japanese); Part B (MAD): AZD1613 (Dose 11) SC or IV; Part B (MAD): AZD1613 (Dose 12) IV; Part B (MAD): AZD1613 (Dose 13) IV

Placebo DRUG

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.

Part A1 (SAD): AZD1613 (Dose 1) SC; Part A1 (SAD): AZD1613 (Dose 2) SC; Part A1 (SAD): AZD1613 (Dose 3) SC; Part A1 (SAD): AZD1613 (Dose 4) SC; Part A1 (SAD): AZD1613 (Dose 5) IV; Part A1 (SAD): AZD1613 (Dose 6) IV; Part A1 (SAD): AZD1613 (Dose 7) IV; Part A2 (SAD): AZD1613 (Dose 8) IV (Chinese); Part A3 (SAD): AZD1613 (Dose 10) SC or IV (Japanese); Part A3 (SAD): AZD1613 (Dose 9) SC or IV (Japanese); Part B (MAD): AZD1613 (Dose 11) SC or IV; Part B (MAD): AZD1613 (Dose 12) IV; Part B (MAD): AZD1613 (Dose 13) IV

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy males and females of non-childbearing potential with suitable veins for cannulation or repeated venipuncture.
• Negative pregnancy test at screening and admission (females only).
• Females of non-childbearing potential confirmed by postmenopausal status or irreversible surgical sterilization.
• Sexually active fertile males must use contraception methods from first administration until 3 months after the last follow-up visit.
• Body mass index (BMI) between 18 and 32 kg/m² and weight at least 50 kg.
• Participants of Chinese descent (Part A2) must have both parents and four grandparents who are Chinese.
• Participants of Japanese descent (Part A3) must have both parents and four grandparents who are Japanese.

You may not qualify if:

• 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.
• History or presence of gastrointestinal, hepatic, or renal disease affecting drug absorption, distribution, metabolism, or excretion of drugs.
• Any clinically important illness, medical/surgical procedure, or trauma within 4 weeks of first administration.
• 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 \[LLN\]).
• Any clinically important abnormalities in clinical chemistry, hematology, or urinalysis results.
• 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).
• 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).
• 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).
• Smokers who smoke more than 5 cigarettes per day and cannot adhere to no smoking during residential visits.
• Known or suspected history of alcohol or drug abuse or excessive alcohol intake.
• Positive screen for drugs of abuse or alcohol at screening or admission.
• History of severe allergy/hypersensitivity or ongoing clinically important allergy/hypersensitivity.
• 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.
• Plasma donation within one month of screening or any blood donation/blood loss \> 500 mL during the 3 months prior to screening.
• Received another new chemical entity within 30 days or 5 half-lives (whichever is longest) of first administration.

Sponsors & Collaborators

• AstraZeneca: lead
• Parexel: collaborator

Study Sites (1)

Research Site

Glendale, California, 91206, United States

RECRUITING

Central Study Contacts

AstraZeneca Clinical Study Information Center

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 28, 2025
• First Posted: May 30, 2025
• Study Start: June 6, 2025
• Primary Completion (Estimated): September 23, 2026
• Study Completion (Estimated): September 23, 2026
• Last Updated: April 27, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA PhRMA Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
• Access Criteria: When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.

Locations

US (1)