Could a single injection tame the immune system in lupus?
NCT ID NCT07749651
First seen Aug 06, 2026 · Last updated Sep 01, 2026 · Updated 3 times
Summary
This early-stage trial is testing a single injection of an experimental drug called SHR-7012 in healthy adults. The main goal is to check how safe and tolerable the drug is, and how the body absorbs and processes it. The study involves about 50 participants aged 18 to 55, who will receive either the drug or a placebo. While this trial does not include people with the disease, the drug is being developed as a potential future treatment for cutaneous lupus erythematosus, a skin condition linked to an overactive immune response.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- SHR-7012 injection
- What this could lead to
- If successful, this could pave the way for a new treatment option for cutaneous lupus erythematosus, a skin condition caused by an overactive immune system.
- What could go wrong
- This is an early-stage trial in healthy volunteers, so it won't show whether the drug works for the disease. The drug may cause side effects or fail to show promise in later trials.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 50 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2026
- Expected to finish
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Aug 2027
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 55 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. The age of signing the informed consent form was between 18 and 55 years old (inclusive), both male and female. 2. Body weight ≥50 kg for men and ≥45 kg for women during the screening period, body mass index (BMI = weight (kg)/ height 2(m2)) between 19.0 and 26.0 kg/m2 (including boundary value) 3. Female participants of childbearing potential and male participants whose partners were fertile women had no plans to give birth, sperm or egg donation within 6 months after signing the informed consent, and voluntarily took highly effective contraceptive methods. Female participants of childbearing potential had to have a serum pregnancy test with a negative result during the screening and baseline periods 4. Female participants: not pregnant or lactatin 5. Before the trial, the participants had understood the nature, significance, possible benefits, possible inconvenience, potential risks and discomfort of the trial in detail, were able to understand the procedures and methods of the study, were willing to strictly abide by the requirements of the entire clinical study, and voluntarily signed informed consent Exclusion Criteria: 1. Patients with previous or current clinical acute or chronic diseases of the circulatory system, endocrine system, nervous system, digestive system, respiratory system, hematology, immunology, psychiatry, or metabolic disorders, who were judged by the investigator to be unsuitable for enrollment 2. Patients had a history of severe herpesvirus infection, a history of malignancy, or current active infection 3. Patients with chronic or recurrent infection requiring treatment within 12 months before screening 4. A screening test for tuberculosis infection (interferon-γ release assay, IGRA) was positive 5. There was a previous history of risk factors for torsades de pointes 6. Patients who had undergone major surgery within 6 months before screening 7. Persons who had been vaccinated within 1 month before screening or planned to be vaccinated during the trial 8. Anyone who had taken any medication or health product (including Chinese herbal medicine) within 7 half-lives or 14 days before dose, whichever was longer, or who had known during the screening period that they might need to receive additional medication during the trial 9. Participants who had participated in a clinical trial and received a trial drug within 3 months before screening or who planned to participate in another clinical trial during the trial 10. Patients were screened if they had donated or lost at least 400 mL of blood (except physiological blood loss in women) within 3 months before the trial, received a transfusion or used blood products, or were planning to donate blood during or within 1 month after the trial 11. People who have special dietary requirements and cannot follow a uniform diet 12. Those with a history of drug abuse, drug use, or a positive screening test for drug abuse 13. Those who have difficulty in venous blood collection/cannot tolerate venipuncture, or have a history of fainting or fainting 14. If the site of administration was abnormal, the investigator judged that subcutaneous administration was not suitable 15. Participants may have been unable to complete the study for other reasons or may have been deemed by the investigator to be unsuitable for enrollment
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Zhejiang Provincial People's Hospital
RECRUITINGHangzhou, Zhejiang, 314408, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Old malaria drug may tame lupus skin flares
- Largest skin lupus database aims to uncover disease patterns
- New drug S-4321 aims to tame overactive immune system
- New pill could tame skin lupus flares
- 10,000 lupus patients needed for landmark online study
- Lupus skin drug trial halted early – what we know