New lupus drug candidate ISH0613 enters first human safety trial

NCT ID NCT07516639

Not yet recruiting Knowledge-focused Sponsor: SUNHO（China）BioPharmaceutical CO., Ltd. Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

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.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

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Conditions

The condition(s) this trial relates to.

systemic lupus erythematosus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

HEALTHY SUBJECTS (HS) SLE (SYSTEMIC LUPUS)

Contacts and locations

Locations

Affiliated Drum Tower Hospital, Medical School of Nanjing University

Nanjing, Jiangsu, 210000, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.