Clinical Trial

The Safety, Tolerability, Pharmacokinetics, Immunogenicity and Preliminary Efficacy of HC022 Injection in Subjects With SLE/CLE

Not Yet Recruiting Phase 1
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Summary
The primary objective of this phase Ib study is to evaluate the safety and tolerability of multiple-ascending, subcutaneous (SC) doses of HC022 in SLE/CLE subjects. Secondary objectives of study are as follows: To estimate the PK parameters of multiple-ascending SC doses of HC022 in SLE/CLE subjects；To evaluate the immunogenicity of HC022 administered to SLE/CLE subjects.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-12-13.
Trial Details
NCT Number NCT07306585
Lead Sponsor HC Biopharma Inc.
Conditions Systemic Lupus Erythematosus (SLE), Cutaneous Lupus Erythematosus (CLE)
Enrollment 32 participants
Start Date 2025-12-30
Primary Completion 2027-03-28 (estimated)
Study Completion 2027-09-24 (estimated)
Updated on ClinicalTrials.gov 2026-01-28