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

NCT07306585 | Not Yet Recruiting Phase 1

• 1 other identifier: BT-HC022-102
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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

Systemic Lupus Erythematosus (SLE); Cutaneous Lupus Erythematosus (CLE)

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

  An AE is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An SAE is any untoward medical occurrence that at any dose: Results in death; in the view of the Investigator, places the participant at immediate risk of death (a life-threatening event); however, this does not include an event that, had it occurred in a more severe form, might have caused death; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; results in a congenital anomaly/birth defect.

  Up to day 141

Secondary Outcomes (6)

• Area Under the Concentration-Time Curve From Time 0 to 28 Days Post-dose (AUC0-28d)

  UP to day 28

• Area Under the Concentration-Time Curve From Time 0 to the Time of the Last Measurable Concentration (AUClast)

  Up to day 141

• Cmax of HC022

  Up to day 141

• Terminal Elimination Half-Life (t1/2) of HC022

  Up to day 141

• Apparent Clearance (CL/F) of HC022

  Up to day 141

Study Arms (4)

HC022 100mg

EXPERIMENTAL

Participants will receive subcutaneous (SC) dose of 100 mg HC022 or matching placebo with a dosing frequency of Q4W (once every 4 weeks), administered subcutaneously twice.

Drug: HC022; Drug: Placebo

HC022 225mg

EXPERIMENTAL

Participants will receive subcutaneous (SC) dose of 225mg HC022 or matching placebo with a dosing frequency of Q4W (once every 4 weeks), administered subcutaneously twice.

Drug: HC022; Drug: Placebo

HC022 450mg

EXPERIMENTAL

Participants will receive subcutaneous (SC) dose of 450mg HC022 or matching placebo with a dosing frequency of Q4W (once every 4 weeks), administered subcutaneously twice.

Drug: HC022; Drug: Placebo

HC022 450mg-2

EXPERIMENTAL

Participants will receive subcutaneous (SC) dose of 450mg HC022 or matching placebo with a dosing frequency of Q4W (once every 4 weeks),1 additional dose at the end of Week 2 (D15) for a total of 3 doses

Drug: HC022; Drug: Placebo

Interventions

HC022 DRUG

Administered as specified in the treatment arm

HC022 100mg; HC022 225mg; HC022 450mg; HC022 450mg-2

Placebo DRUG

Administered as specified in the treatment arm

HC022 100mg; HC022 225mg; HC022 450mg; HC022 450mg-2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Subjects who voluntarily participate in the study, are able to sign the informed consent form and comply with the requirements on the informed consent form;
• \. Age ≥ 18 years, regardless of gender;
• \. Subjects and their partners have no birth plan during the study treatment period and within 6 months after the last dose, and voluntarily use effective and reliable contraception (Attachment 1). Female subjects must have a negative serum pregnancy test and be non-lactating;
• \. Patients diagnosed with SLE or CLE by the investigator

You may not qualify if:

• \. active severe lupus nephritis
• \. active neuropsychiatric SLE
• History or current diagnosis of any other systemic autoimmune disease other than secondary Sjogren's syndrome, including but not limited to rheumatoid arthritis, psoriatic arthritis, dermatomyositis, systemic sclerosis (scleroderma), clinically significant non-SLE related vasculitis;
• \. Drug-induced lupus;
• \. HIV medical history or positive test results, treponema pallidum antibody positive, hepatitis B infection (HBsAg or HBcAb positive), hepatitis C infection (HCV antibody positive and quantitative abnormality), cytomegalovirus infection (IgM positive and quantitative abnormality) and Epstein-Barr virus infection (IgM positive and quantitative abnormality);
• History of tuberculosis infection, or evidence of active or latent mycobacterium tuberculosis infection at the time of signing informed consent;
• \. The following laboratory abnormalities were present, including but not limited to: a) Subjects with abnormal liver function: e.g., aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \> 2 times the upper limit of normal (ULN), or total bilirubin \> 1.5 × ULN (except for those due to Gilbert syndrome); or b) Subjects with abnormal hematology: Hemoglobin \< 90 g/L, or platelet count \< 75 x 109/L, or absolute neutrophil count \< 1.5 x 109/L;
• \. Subjects with a history of chronic, recurrent (3 or more infections of the same type within 1 year) or severe infections (e.g. pneumonia and sepsis) within half a year before informed consent as determined by the investigator, including viral infection, or requiring systemic anti-infective treatment within 12 weeks before informed consent;
• History of severe herpes infection (e.g., herpetic encephalitis, ocular herpes or diffuse herpes) or signs of herpes or varicella-zoster virus infection within 12 weeks prior to knowledge (especially chickenpox and herpes zoster);
• \. History or current history of malignant disease, including solid tumors and hematologic malignancies (except for basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and cervical cancer in situ that have been completely removed and considered cured \> 2 years at the time of informed consent).
• \. New York Heart Association Functional Class III or IV congestive heart failure
• \. Subjects with informed consent or abnormal and clinically significant ECG results before administration
• Patients with suicidal behavior or thoughts within 1 year before informed consent;
• Subjects with a history of drug abuse within 12 months before informed consent, or positive baseline urine drug test results;
• \. Use the prohibited drugs stipulated in the plan

Sponsors & Collaborators

• HC Biopharma Inc.: lead

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

Location

MeSH Terms

Conditions

Lupus Erythematosus, Systemic; Lupus Erythematosus, Cutaneous

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Skin Diseases

Central Study Contacts

QiQi huang Huang, master

CONTACT

18221247718; qiqi.huang@btyy.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 5, 2025
• First Posted: December 29, 2025
• Study Start: December 30, 2025
• Primary Completion (Estimated): March 28, 2027
• Study Completion (Estimated): September 24, 2027
• Last Updated: January 28, 2026

Record last verified: 2026-01

Locations

CN (1)