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NOT YET RECRUITING
NCT07306585
PHASE1

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

Sponsor: HC Biopharma Inc.

View on ClinicalTrials.gov

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.

Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled Phase Ib Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity Characteristics and Preliminary Efficacy of Multiple Ascending Doses of HC022 Injection in Subjects With Systemic Lupus Erythematosus and/or Cutaneous Lupus Erythematosus

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

32

Start Date

2025-12-30

Completion Date

2027-09-24

Last Updated

2026-01-28

Healthy Volunteers

No

Interventions

DRUG

HC022

Administered as specified in the treatment arm

DRUG

Placebo

Administered as specified in the treatment arm

Locations (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China