First-in-Human Study of ISH0613: Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics

The goal of this clinical trial is to learn about a study drug called ISH0613 and how it behaves in healthy adults. This study will also evaluate the safety and tolerability of ISH0613 after a single intravenous (IV) dose. The main questions this study aims to answer are: I. What medical problems (side effects) may occur after receiving ISH0613? How does ISH0613 move through and get processed in the body? II. Does ISH0613 affect certain biological markers related to the immune system? III. Researchers will compare ISH0613 to a placebo (a look-alike substance that contains no active drug) to better understand its effects. Participants will: I. Receive a single intravenous infusion of either ISH0613 or placebo II. Stay in the clinical unit for several days for close monitoring after dosing III. Return to the clinic for follow-up visits over several weeks IV. Provide blood samples for safety checks and laboratory testing V. Be monitored for any side effects throughout the study

NCT Number	NCT07516639
Lead Sponsor	SUNHO（China）BioPharmaceutical CO., Ltd.
Conditions	Healthy Subjects (HS), SLE (Systemic Lupus)
Enrollment	26 participants
Start Date	2026-04-01
Primary Completion	2026-12-31 (estimated)
Study Completion	2026-12-31 (estimated)
Updated on ClinicalTrials.gov	2026-04-13