Trials / Not Yet Recruiting
Not Yet RecruitingNCT07306585
The Safety, Tolerability, Pharmacokinetics, Immunogenicity and Preliminary Efficacy of HC022 Injection in Subjects With SLE/CLE
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
- Status
- Not Yet Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 32 (estimated)
- Sponsor
- HC Biopharma Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
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
- 2025-12-30
- Primary completion
- 2027-03-28
- Completion
- 2027-09-24
- First posted
- 2025-12-29
- Last updated
- 2026-01-28
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT07306585. Inclusion in this directory is not an endorsement.