Not Yet RecruitingPhase 1

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

China32 participantsStarted 2025-12-30

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 1\. 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; * 2\. Age ≥ 18 years, regardless of gender; * 3\. 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; * 4\. Patients diagnosed with SLE or CLE by the investigator Exclusion Criteria: * 1\. active severe lupus nephritis * 2\. active neuropsychiatric SLE * 3 .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; * 4\. Drug-induced lupus; * 5\. 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); * 6.History of tuberculosis infection, or evidence of active or latent mycobacterium tuberculosis infection at the time of signing informed consent; * 7\. The …

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: Up to day 141

Trial details

NCT IDNCT07306585

SponsorHC Biopharma Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-03-28

Contact for this trial

QiQi huang Huang, master

18221247718 qiqi.huang@btyy.com

View on ClinicalTrials.gov More Systemic Lupus Erythematosus (SLE) trials