Clinical Trial

Safety, Tolerability, and Pharmacokinetics of Single Doses of HC022 in Healthy Subjects.

Recruiting Phase 1
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Record status
This record was last updated April 17, 2025 (before its estimated August 30, 2025 completion). Its status may not reflect the trial's current state.
Summary
The primary objective of this phase Ia study is to evaluate the safety and tolerability of single-ascending, subcutaneous (SC) doses of HC022 in healthy subjects. Secondary objectives of study are as follows: To estimate the PK parameters of single-ascending SC doses of HC022 in healthy subjects；To evaluate the immunogenicity of HC022 administered to healthy subjects.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2024-10-23.
Status change: Not Yet Recruiting → Recruiting 2025-04-16
Trial Details
NCT Number NCT06657703
Lead Sponsor HC Biopharma Inc.
Conditions Systemic Lupus Erythematosus
Enrollment 38 participants
Start Date 2024-11-25
Primary Completion 2025-08-30 (estimated)
Study Completion 2026-01-08 (estimated)
Updated on ClinicalTrials.gov 2025-04-17