Healthy volunteers needed for early safety test of experimental drug
NCT ID NCT06995820
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-stage study tests the safety and how the body handles a new drug called AZD1613. About 136 healthy adults, including those of Japanese and Chinese descent, will receive either the drug or a placebo. The goal is to check for side effects and measure drug levels in the body, not to treat any disease.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 136 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2025
- Expected to finish
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Sep 2026
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 50 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Research Site
RECRUITINGGlendale, California, 91206, United States
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