New lupus drug candidate ISH0613 enters first human safety trial
NCT ID NCT07516639
First seen Apr 10, 2026 · Last updated Jun 23, 2026 · Updated 10 times
Summary
This early-stage trial is the first time ISH0613 will be given to humans. It aims to check the drug's safety and how it moves through the body in 26 healthy Chinese adults. Participants receive a single intravenous dose of either ISH0613 or a placebo and are closely monitored for side effects. This study does not test if the drug works for lupus, but it is a necessary first step before future patient trials.
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This is a summary of
the original study
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Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.
This is a summary of the original study . Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.
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Contacts and locations
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Study contacts
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Contact
Phone: •••-•••-•••• Email: •••••@•••••
Locations
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Affiliated Drum Tower Hospital, Medical School of Nanjing University
Nanjing, Jiangsu, 210000, China
What this could mean
Our plain-language read of the trial. This is informational only — not medical advice or a prediction.
Active substance
ISH0613
What this could lead to
If this early trial shows the drug is safe and well-tolerated, it could pave the way for larger studies testing ISH0613 as a potential treatment for lupus.
What could go wrong
This is a very early Phase 1 study in only 26 healthy people, so it cannot tell us if the drug works for lupus. Side effects are unknown, and many drugs fail at this stage.
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.