NCT06801119

Efficacy and Safety of HN2301 in Autoimmune Diseases（AIDs）

Dose-escalation Study to Assess the Safety, Tolerability, and Preliminary Efficacy of HN2301 in Patients With Autoimmune Diseases Including Systemic Lupus Erythematosus（SLE）, Systemic Sclerosis (SSc) and Rheumatoid Arthritis （RA）

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Shenzhen MagicRNA Biotechnology Co., Ltd · Industry
• Sex: All
• Age: 18 Years – 69 Years
• Healthy volunteers: Not accepted

Summary

This is an open lable and single arm study, is designed to evaluate the safety and preliminary efficacy of HN2301 in Autoimmune Disease（AID）

Detailed description

This study is a prospective exploratory clinical trial in subjects with Autoimmune Disease（SLE, SSc, RA, etc.）. The objective is to evaluate the safety and efficacy of HN2301 injection in Autoimmune Disease (SLE, SSc, RA, etc.).

Conditions

• Systemic Lupus Erythematosus
• Scleroderma
• Rheumatoid Arthritis

Interventions

Type	Name	Description
DRUG	HN2301 injection	Dosing will begin at a lower dose level and may be escalated to dose levels considered safe and potentially effective according to the study protocol.

Timeline

• Start date: 2025-03-16
• Primary completion: 2027-12-31
• Completion: 2028-06-30
• First posted: 2025-01-30
• Last updated: 2026-04-13

Locations

1 site across 1 country: China