Safety and Preliminary Efficacy of HN2302 in Patients With Autoimmune Diseases

Sponsor
Shenzhen MagicRNA Biotechnology Co., Ltd
Study ID
NCT07523282
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 69 Years
Healthy Volunteers
Not accepted

Interventions

  • HN2302 Injection — DRUG
    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.

Study Details

This is an open-label, single-arm study designed to evaluate the safety and preliminary efficacy of HN2302 in patients with autoimmune diseases, including systemic lupus erythematosus (SLE) and systemic sclerosis (SSc).

Key Dates

First listed
Apr 13, 2026
Start date
Apr 28, 2026
Status verified
Apr 2026
Primary completion
Dec 31, 2027
Completion
Jun 30, 2028

Study Design

Enrollment
12 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: HN2302 treatment group
    Participants will receive HN2302 Injection at the specified dose level and on the specified study days.

Primary Outcome Measure

Incidence of treatment-emergent adverse events (TEAEs) [ Time Frame: Up to 3 months ]

Central Contacts

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