Actively Recruiting
A Study to Investigate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Immunogenicity of AZD1613 in Healthy Participants.
Led by AstraZeneca · Updated on 2026-04-27
136
Participants Needed
1
Research Sites
67 weeks
Total Duration
On this page
Sponsors
A
AstraZeneca
Lead Sponsor
P
Parexel
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
A Study to Investigate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Immunogenicity of AZD1613 in Healthy Participants.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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/m8 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 will not qualify if you...
- History of any clinically important disease or disorder that may risk participant safety, affect study results, or participation ability.
- History or presence of gastrointestinal, liver, or kidney disease affecting drug processing.
- Any significant illness, medical/surgical procedure, or trauma within 4 weeks before first dose.
- Abnormal lab values at screening or admission, including elevated liver enzymes, bilirubin, low kidney function, or low hemoglobin.
- Clinically important abnormalities in clinical chemistry, blood tests, or urinalysis.
- Positive tests for hepatitis B, hepatitis C, or HIV.
- Abnormal vital signs after 5 minutes resting, including high or low blood pressure or heart rate.
- Abnormal resting ECG, including prolonged or shortened QT intervals or family history of long QT syndrome.
- Smokers of more than 5 cigarettes daily who cannot abstain during residential visits.
- History or suspicion of alcohol or drug abuse, or excessive alcohol intake.
- Positive drug or alcohol screen at screening or admission.
- History of severe allergy or ongoing clinically important allergy.
- Use of medications including antacids, analgesics (except paracetamol), herbal remedies, or high-dose vitamins within 2 weeks before first dose.
- Plasma donation within 1 month or blood loss over 500 mL within 3 months before screening.
- Receipt of another new chemical entity within 30 days or 5 half-lives before first dose.
- Previous receipt of AZD1613.
- Involvement in planning or conduct of this study.
- Investigator judgment of minor medical complaints or non-compliance.
- Medical dietary restrictions or inability/unwillingness to comply with meals during clinical stay.
- Inability to communicate reliably with Investigator.
- Vulnerable participants such as those in detention or under guardianship.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Research Site
Glendale, California, United States, 91206
Actively Recruiting
Research Team
A
AstraZeneca Clinical Study Information Center
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
13
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