RecruitingPhase 1NCT06801119

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)


Sponsor

Shenzhen MagicRNA Biotechnology Co., Ltd

Enrollment

30 participants

Start Date

Mar 16, 2025

Study Type

INTERVENTIONAL

Conditions

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)


Eligibility

Min Age: 18 YearsMax Age: 69 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new drug called HN2301 in patients with autoimmune diseases — particularly lupus (SLE) — whose disease remains active despite standard treatment. **You may be eligible if...** - You are between 18 and 69 years old - You have a confirmed lupus (SLE) diagnosis for at least 6 months - Your disease is still active or has flared up despite being on a stable treatment regimen for at least 8 weeks - Your current medications include anti-inflammatories, antimalarials, steroids, or immunosuppressants **You may NOT be eligible if...** - You have severe organ damage from lupus (such as severe kidney or brain involvement) - You have a serious active infection - You are pregnant or breastfeeding - You have had recent major surgery or other cancer Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGHN2301 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.


Locations(1)

The First Affiliated Hospital of University of Science and Technology of China

Hefei, Anhui, China

View Full Details on ClinicalTrials.gov

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NCT06801119


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