Systemic Lupus Erythematosus (SLE)Phase 1NCT07306585
The Safety, Tolerability, Pharmacokinetics, Immunogenicity and Preliminary Efficacy of HC022 Injection in Subjects With SLE/CLE
A Phase 1 study testing HC022 in people with Systemic Lupus Erythematosus (SLE) and Cutaneous Lupus Erythematosus (CLE), run by HC Biopharma Inc. at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Systemic Lupus Erythematosus (SLE), Cutaneous Lupus Erythematosus (CLE)
- What is being tested?
- HC022
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteChina
- Study dates
- 30 Dec 2025to 24 Sep 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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;
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- 7. 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;
- 8. 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;
- 9.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);
- 10. 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).
- 11. New York Heart Association Functional Class III or IV congestive heart failure
- 12. Subjects with informed consent or abnormal and clinically significant ECG results before administration
- 13.Patients with suicidal behavior or thoughts within 1 year before informed consent;
- 14.Subjects with a history of drug abuse within 12 months before informed consent, or positive baseline urine drug test results;
- 15. Use the prohibited drugs stipulated in the plan
- 16. Antimalarials were started within 12 weeks prior to randomization, and subjects must have been on a stable dose from screening through the end of study (only for CLE patients) if they were receiving antimalarial treatment at screening;
- 17. Treatment with oral systemic corticosteroids at doses greater than 15 mg/day prednisone (or its equivalent) prior to randomization (only for patients with CLE);
- 18. Patients who have previously received drugs that inhibit BDCA2 targets;
- 19. Subjects who have participated in other clinical trials within 4 weeks before informed consent, or within 5 half-lives of the investigational drug, whichever is longer;
- 20. Presence of a past or present condition other than SLE and/or CLE that, in the opinion of the Investigator, may interfere with the assessment of skin inflammation and disease activity;
- 21. Subjects who are allergic to the investigational drug (including excipients) or suffer from serious allergic diseases or have an allergic constitution (such as allergy to two or more drugs, food or pollen), which may impair the safety of subjects in the judgment of the investigator;
- 22. Tattoos, scars or other physical examination findings in the area of planned injection sites that interfere with local injection site evaluation;
- 23. Live vaccine or live attenuated vaccine within 4 weeks before informed consent, or planned during the study and within 24 weeks after the last dose of study drug;
- 24. Subjects with a blood donation volume ≥ 500 mL within 4 weeks before informed consent or planned during the study, or have a history of blood transfusion within 4 weeks before informed consent;
- 25. Subjects with an average daily alcohol intake of more than 2 units (1 unit of alcohol ≈ 360 mL of beer containing 5% alcohol or 45 mL of spirits containing 40% alcohol or 150 mL of wine containing 12% alcohol) within 3 months before informed consent, or subjects with positive baseline alcohol breath test;
- 26. Other reasons that the investigator considers unsuitable for participation in this study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730
xiaofeng Zeng, PHD, 08613501069845, xiaofeng.zeng@cstar.org.cn
About this study
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
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.
- Being tested
- HC022, Placebo
- Medical subject headings
- Lupus Erythematosus, Systemic, Lupus Erythematosus, Cutaneous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HC022Drug
Administered as specified in the treatment arm
PlaceboDrug
Administered as specified in the treatment arm
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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 Receives: Drug: HC022; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to day 141
Secondary outcomes (6)
Area Under the Concentration-Time Curve From Time 0 to 28 Days Post-dose (AUC0-28d)
Measured: UP to day 28
Area Under the Concentration-Time Curve From Time 0 to the Time of the Last Measurable Concentration (AUClast)
Measured: Up to day 141
Cmax of HC022
Measured: Up to day 141
Terminal Elimination Half-Life (t1/2) of HC022
Measured: Up to day 141
Apparent Clearance (CL/F) of HC022
Measured: Up to day 141
Number of Participants Who Develop Serum Anti-HC022 Antibodies
Measured: Up to day 141
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2025
- Study start30 Dec 2025 (estimated)
- Primary completion28 Mar 2027 (estimated)
- Study completion24 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic Lupus Erythematosus (SLE)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- HC Biopharma Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07306585
- Sponsor's protocol ID
- BT-HC022-102
- Status last verified
- Jan 2026
- First submitted
- 5 Sep 2025
- Last updated
- 28 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07306585
- Acronym / sponsor ID
- BT-HC022-102
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- HC Biopharma Inc.Industry (pharma, biotech, devices)
- Study start
- 30 Dec 2025 (estimated)
- Primary completion
- 28 Mar 2027 (estimated)
- Study completion
- 24 Sep 2027 (estimated)
- First posted
- 29 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| HC022 100mg | Experimental | Drug: HC022, Drug: PlaceboParticipants 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. |
| HC022 225mg | Experimental | Drug: HC022, Drug: PlaceboParticipants will receive subcutaneous (SC) dose of 225mg HC022 or matching placebo with a dosing frequency of Q4W (once every 4 weeks), administered subcutaneously twice. |
| HC022 450mg | Experimental | Drug: HC022, Drug: PlaceboParticipants will receive subcutaneous (SC) dose of 450mg HC022 or matching placebo with a dosing frequency of Q4W (once every 4 weeks), administered subcutaneously twice. |
| HC022 450mg-2 | Experimental | Drug: HC022, Drug: PlaceboParticipants 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (26 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HC022Administered as specified in the treatment arm | Drug | HC022 100mg, HC022 225mg, HC022 450mg, HC022 450mg-2 |
| PlaceboAdministered as specified in the treatment arm | Drug | HC022 100mg, HC022 225mg, HC022 450mg, HC022 450mg-2 |
Primary outcome
Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: Up to day 141
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.
6 secondary outcomes
Area Under the Concentration-Time Curve From Time 0 to 28 Days Post-dose (AUC0-28d)
Time frame: UP to day 28
Area Under the Concentration-Time Curve From Time 0 to the Time of the Last Measurable Concentration (AUClast)
Time frame: Up to day 141
Cmax of HC022
Time frame: Up to day 141
Terminal Elimination Half-Life (t1/2) of HC022
Time frame: Up to day 141
Apparent Clearance (CL/F) of HC022
Time frame: Up to day 141
Number of Participants Who Develop Serum Anti-HC022 Antibodies
Time frame: Up to day 141
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing HC022 in people with Systemic Lupus Erythematosus (SLE) and Cutaneous Lupus Erythematosus (CLE), run by HC Biopharma Inc. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 28 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact QiQi huang Huang, master (18221247718, qiqi.huang@btyy.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) (time frame: Up to day 141). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2026.