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NCT07306585
The Safety, Tolerability, Pharmacokinetics, Immunogenicity and Preliminary Efficacy of HC022 Injection in Subjects With SLE/CLE
Phase 1 trial testing HC022 in Systemic Lupus Erythematosus (SLE) in 32 participants. Not yet recruiting.
28 March 2027
Quick facts
| Lead sponsor | HC Biopharma Inc. |
|---|---|
| Phase | Phase 1 |
| Status | Not yet recruiting |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 32 |
| Start date | 30 December 2025 |
| Primary completion | 28 March 2027 |
| Estimated completion | 24 September 2027 |
| Sites | 1 location across China |
Drugs / interventions tested
- HC022 — full drug profile →
- Placebo
Conditions studied
- Systemic Lupus Erythematosus (SLE) — all drugs for Systemic Lupus Erythematosus (SLE) →
- Cutaneous Lupus Erythematosus (CLE) — all drugs for Cutaneous Lupus Erythematosus (CLE) →
Sponsor
HC Biopharma Inc. — full company profile →
Who can join
18 and older, any sex, with Systemic Lupus Erythematosus (SLE) or Cutaneous Lupus Erythematosus (CLE). Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT07306585
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of HC022
Trials testing the same drug.
- NCT06657703 — Safety, Tolerability, and Pharmacokinetics of Single Doses of HC022 in Healthy Subjects. · Phase 1 · recruiting
Other recruiting trials for Systemic Lupus Erythematosus (SLE)
Currently open trials in the same condition.
- NCT07447986 — To Evaluate the Efficacy and Safety of SG301 SC Injection in Systemic Lupus Erythematosus · Phase 2 · recruiting
- NCT07490041 — Exploratory Clinical Study on the Safety and Efficacy of Anti- CD19/BCMA CAR-NK Cell Injection for the Treatment of Refr · EARLY_PHASE1 · recruiting
- NCT07087912 — Safety and Immunogenicity of the Live Attenuated Tetravalent Butantan-Dengue Vaccine in Autoimmune Rheumatic Diseases · Phase 4 · recruiting
- NCT07332481 — A Study of Enpatoran in Participants With Cutaneous Manifestations of Lupus With or Without Systemic Disease · Phase 3 · recruiting
- NCT06875960 — A Study to Continue the Administration of Deucravacitinib in Participants With Systemic Lupus Erythematosus (SLE) or Dis · Phase 4 · recruiting
Other HC Biopharma Inc. trials
Trials by the same sponsor.
- NCT07477743 — A Phase Ib Clinical Study on the Safety and Efficacy of HC010 Combinations in Advanced Solid Tumors · Phase 1 · recruiting
- NCT07169552 — HC010 in First-line PD-L1 Positive Advanced NSCLC Patients · Phase 2 · recruiting
- NCT07381829 — A Phase Ib Clinical Study on the Safety and Efficacy of HC010 Combined With Chemotherapy in Lung Cancer · Phase 1 · recruiting
- NCT06963814 — Study of HC006 in Combination With a PD-1 Inhibitor in Patients With Advanced Solid Tumors · Phase 1 · recruiting
- NCT06657703 — Safety, Tolerability, and Pharmacokinetics of Single Doses of HC022 in Healthy Subjects. · Phase 1 · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07306585 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by HC Biopharma Inc.
- Last refreshed: 28 January 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07306585.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing