Safety study of AZD1613 in healthy volunteers
This is a first-in-human trial testing an experimental drug (AZD1613) in healthy volunteers. It helps doctors see if the drug is safe, how it is processed by the body, and how the immune system reacts. The trial is designed for healthy men and women who cannot become pregnant and may require participants to be of Chinese or Japanese descent for certain groups.
Summary written for real people, not researchers, by Clin2.
Who can take part
- You must be a healthy adult man or a woman who cannot become pregnant (because you have gone through menopause or have had surgery to prevent pregnancy).
- Your body mass index (BMI) must be between 18 and 32, and you must weigh at least 110 pounds (50 kg).
- If you are a man and could father a child, you must use birth control from your first dose until 3 months after the last visit.
- You cannot have any significant medical problems, including problems with your liver, kidneys, heart, or stomach, and you must not smoke more than 5 cigarettes a day.
- Some parts of the study (Part A2) require that you are of Chinese descent, and Part A3 requires that you are of Japanese descent (both parents and all grandparents must be from that ethnic group).
- You cannot be taking any prescription or over-the-counter medications (except for acetaminophen/paracetamol) in the 2 weeks before the study starts.
Quick eligibility check
Answer a few plain-language questions, based on this study's own requirements, to get a preliminary sense of fit.
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