Testing an investigational medicine in healthy volunteers
This trial tests a new medication (called BW-20805-2-1001) in healthy volunteers to see if it is safe and how the body handles it. It may help in developing future treatments for certain diseases, though it's not yet known if it will benefit you directly.
Summary written for real people, not researchers, by Clin2.
Who can take part
- You must be a healthy adult, aged 18 to 60 years.
- Your body mass index (BMI) should be between 18 and 32, and your weight should be at least 50 kg (about 110 lbs).
- You cannot be pregnant or planning to become pregnant, and if you're a male with a partner who could become pregnant, you must use effective birth control for a long period (about 48 weeks) after the study.
- You should not have any serious medical conditions, active infections (like hepatitis B), or a history of cancer.
- Your blood pressure must be within normal range (not consistently above 140/90 mmHg).
- You must not be taking any prescription or over-the-counter medications (except birth control), including any investigational drugs within the last 30 days.
- You must not have had siRNA treatment (a type of gene-silencing therapy) in the past 12 months.
- You should not smoke more than 10 cigarettes (or equivalent) per day, and you must be willing to avoid smoking for 48 hours before staying at the clinic.
- You cannot have a history of alcohol or drug abuse in the past 12 months, and you must pass drug and alcohol tests.
- You must not have donated a large amount of blood (over 200 mL) in the past 30 days.
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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