NCT06657703

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

A Phase Ia Single Center, Randomized, Double-blind, Placebo-controlled Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Single Doses of HC022 in Healthy Subjects

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 38 (estimated)
• Sponsor: HC Biopharma Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Detailed description

This is a first-in-human study of HC022 to assess safety, tolerability, and pharmacokinetic (PK) and pharmacodynamic (PD) effects of single HC022 doses in healthy subjects.

Conditions

• Systemic Lupus Erythematosus

Interventions

Type	Name	Description
DRUG	HC022	Administered as specified in the treatment arm
DRUG	Placebo	Administered as specified in the treatment arm

Timeline

• Start date: 2024-11-25
• Primary completion: 2025-08-30
• Completion: 2026-01-08
• First posted: 2024-10-24
• Last updated: 2025-04-17

Locations

3 sites across 1 country: China