First Safety Study of ISH0613 in Healthy Adults
Part of Immune system & allergy, Skin clinical trials.
This is an early-stage safety study testing a new monoclonal antibody (a type of protein medicine) called ISH0613 in healthy volunteers. The study will look at how safe the drug is, how your body handles it, and what effects it has.
Summary written for real people, not researchers, by Clin2.
Who can take part
- You must be a healthy Chinese adult between 18 and 45 years old
- Your body mass index (BMI) must be between 19.0 and 28.0, and you must weigh at least 50 kg (men) or 45 kg (women)
- You cannot be pregnant, breastfeeding, or planning to get pregnant during the study; you must use reliable birth control
- You must have no active infections, no history of tuberculosis, and negative tests for hepatitis B, hepatitis C, HIV, and syphilis
- You cannot take any prescription drugs, over-the-counter medications, or traditional Chinese medicines for 2 weeks before the study starts
- You must avoid alcohol, limit smoking to 5 cigarettes per day or less, and stay away from illegal drugs for at least 3 months before the study
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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