drugset / Trial / NCT07306585

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

NCT07306585 ↗

Phase 1 Not yet recruiting 32 enrolled HC Biopharma Inc.
RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start
2025-12-30
Primary completion
2027-03-28
Completion
2027-09-24

Drugs

EvaluationDrugModalityDoseRoute
Subject HC022 Unknown 100 mg Subcutaneous
Subject HC022 Unknown 225 mg Subcutaneous
Subject HC022 Unknown 450 mg Subcutaneous