NCT07516639

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

A Randomized, Double-Blind, Placebo-Controlled Phase Ia First-in-Human Study to Evaluate the Single Intravenous Administration of ISH0613 in Healthy Subjects

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 26 (estimated)
• Sponsor: SUNHO（China）BioPharmaceutical CO., Ltd. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

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

Conditions

• Healthy Subjects (HS)
• SLE (Systemic Lupus)

Interventions

Type	Name	Description
DRUG	ISH0613 for injection	80, 240, 480, 640 mg; i.v.
DRUG	Placebo	80, 240, 480, 640 mg; i.v.

Timeline

• Start date: 2026-04-01
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2026-04-08
• Last updated: 2026-04-13

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated drug study