NCT07483346

IASO-782 in Systemic Lupus Erythematosus

A Phase Ib Study to the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of IASO-782 in Patient With Systemic Lupus Erythematosus

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Shanghai IASO Biotechnology Co., Ltd · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

his study is a randomized, double-blinded, and placebo-controlled phase Ia clinical study in subjects with SLE. The study is designed to assess the safety and tolerability of IASO-782 for the treatment of SLE.

Detailed description

This study is a multiple-dose escalation study in subjects with SLE. The study is designed to enroll subjects with SLE. This study will evaluate the safety and preliminary dose range of IASO-782 in subjects with SLE at the following dose levels:4mg/kg，6mg/kg and 10mg/kg.

Conditions

• SLE - Systemic Lupus Erythematosus

Interventions

Type	Name	Description
DRUG	IASO-782 injection	Each subject will be given only one dose of IASO-782. Subjects should avoid strenuous exercise within 48 h before administration and remain seated or semi-recumbent (except for necessary activities) for 4 h after administration. IASO-782 solution for injection or placebo was diluted in 0.9% sodium chloride injection (corresponding to the dose administered according to the body weight at baseline and the dose group) with a total volume of 250 mL, administered as a single intravenous drip at a drip rate recommended by the drug manual on the day of administration, The infusion time is about 90 minutes (± 15 minutes).
DRUG	Placebo	Each subject will be given one dose of placebo. Subjects should avoid strenuous exercise within 48 h before administration and remain seated or semi-recumbent (except for necessary activities) for 4 h after administration. IASO-782 solution for injection or placebo was diluted in 0.9% sodium chloride injection (corresponding to the dose administered according to the body weight at baseline and the dose group) with a total volume of 250 mL, administered as a single intravenous drip at a drip rate recommended by the drug manual on the day of administration, The infusion time is about 90 minutes (± 15 minutes).

Timeline

• Start date: 2026-04-30
• Primary completion: 2027-08-31
• Completion: 2028-05-31
• First posted: 2026-03-19
• Last updated: 2026-03-19