SLE - Systemic Lupus ErythematosusPhase 1NCT07483346
IASO-782 in Systemic Lupus Erythematosus
A Phase 1 study testing IASO-782 injection in people with SLE - Systemic Lupus Erythematosus, run by Shanghai IASO Biotechnology Co., Ltd at 4 sites in China.
Trial summary
his study is a randomized, double-blinded, and placebo-controlled phase Ia clinical study in subjects with SLE. The study is designed to assess the safety and tolerability of IASO-782 for the treatment of SLE. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- SLE - Systemic Lupus Erythematosus
- What is being tested?
- IASO-782 injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 4 sitesChina
- Study dates
- 26 May 2026to 31 May 2028
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18 to 75 years;
- Clinically confirmed diagnosis of SLE before screening;
- Currently receiving standard treatment regimens, including any single drug or combination of drugs;
- Organ function or laboratory test is basically normal;
- Subjects with potential fertility and their partners must use effective contraceptive measures for at least 2 weeks before the first dose of the study drug, throughout the study period, and for 6 months after the end of the study (or early termination of the study);
- Females with potential fertility must have a negative pregnancy test during the Screening Phase;
- Voluntarily participate in the study and sign the informed consent form.
Who cannot join
- History of other primary malignant neoplasm within 5 years of screening;
- A history of cardiac disease within the recent 3 months, including New York Heart Association (NYHA) Class III/IV congestive heart failure and cardiac arrhythmias requiring drug treatment;
- Subjects with poorly controlled hypertension despite drug treatment;
- A history of hypersensitivity to any component of the study drug or its excipients confirmed before screening;
- Presence of active infection requiring intravenous drug treatment within 30 days before screening;
- Pregnant or lactating females;
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- Participation in any other clinical trial within 28 days before randomization or within 5 half-lives of the study drug in the other trial (whichever is longer);
- Previous treatment drugs have not been adequately washed out;
- A previous history of any arterial or venous thrombosis (stroke, transient ischemic attack, myocardial infarction, deep vein thrombosis or pulmonary embolism), or clinical symptoms and medical history suggesting thrombophilia; or any of the following: cardiac arrhythmias known to increase the risk of thrombotic events (e.g., atrial fibrillation), or a corrected QT interval (QTc) >450 msec in the subject; or a history of other coagulation abnormalities;
- Confirmed diagnosis of severe lupus nephritis within 8 weeks before screening (defined as urine protein >6 g/24 hours or serum creatinine >2.5 mg/dL or 221 μmol/L), or requiring treatment with study-prohibited drugs, or having active nephritis requiring prednisone ≥100 mg/day or equivalent glucocorticoid for ≥14 days; active severe or unstable neuropsychiatric SLE, including but not limited to poorly controlled seizures, psychosis or acute confusional state, cerebrovascular accident, demyelinating syndrome, cranial nerve palsy, or evidence of active central nervous system vasculitis within 12 weeks before the screening visit;
- Hepatitis B virus (HBV) infection during the Screening Phase (if HBsAg is positive, or HBsAg is negative but anti-HBc is positive, HBV-DNA testing is required, and the subject will be excluded if viral replication is indicated); positive anti-hepatitis C virus (HCV) antibody with positive peripheral blood HCV RNA; positive human immunodeficiency virus (HIV) antibody; positive specific treponema pallidum antibody with positive rapid plasma reagin test;
- Tuberculosis (TB) infection: TB testing will be appropriately performed during screening according to local clinical practice. Subjects with active tuberculosis will be excluded, except for those with latent TB who are judged by the investigator to be eligible for the study;
- A history of substance abuse or mental disorders;
- Any other medical history or condition judged by the investigator to be unsuitable for study participation.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China4 sites, 4 recruiting
- Recruiting
Affiliated Hangzhou First People's Hospital, Westlake University, School of Medicine
Hangzhou, Zhejiang, 310000
Changpu Cao, +86 13584069411, changpu.cao@iasobio.com
Jiao huang
- Recruiting
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310000
Changpu Cao, +86 13584069411, changpu.cao@iasobio.com
Jin Lin
- Recruiting
Huzhou Central Hospital
Huzhou, Zhejiang, 313000
Changpu Cao, +86 13584069411, changpu.cao@iasobio.com
Youqing Wang
- Recruiting
The First Hospital of Jiaxing
Jiaxing, Zhejiang, 314000
Changpu Cao, +86 13584069411, changpu.cao@iasobio.com
Bin Zhang
About this study
Official title: A Phase Ib Study to the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of IASO-782 in Patient With Systemic Lupus Erythematosus
his study is a randomized, double-blinded, and placebo-controlled phase Ia clinical study in subjects with SLE. The study is designed to assess the safety and tolerability of IASO-782 for the treatment of SLE.
Read the detailed description
This study is a multiple-dose escalation study in subjects with SLE. The study is designed to enroll subjects with SLE. This study will evaluate the safety and preliminary dose range of IASO-782 in subjects with SLE at the following dose levels:4mg/kg，6mg/kg and 10mg/kg.
- Conditions
- SLE - Systemic Lupus Erythematosus
- Being tested
- IASO-782 injection, Placebo
- Medical subject headings
- Lupus Erythematosus, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IASO-782 injectionDrug
Each subject will be given only one dose of IASO-782. Subjects should avoid strenuous exercise within 48 h before administration and remain seated or semi-recumbent (except for necessary activities) for 4 h after administration. IASO-782 solution for injection or placebo was diluted in 0.9% sodium chloride injection (corresponding to the dose administered according to the body weight at baseline and the dose group) with a total volume of 250 mL, administered as a single intravenous drip at a drip rate recommended by the drug manual on the day of administration, The infusion time is about 90 minutes (± 15 minutes).
PlaceboDrug
Each subject will be given one dose of placebo. Subjects should avoid strenuous exercise within 48 h before administration and remain seated or semi-recumbent (except for necessary activities) for 4 h after administration. IASO-782 solution for injection or placebo was diluted in 0.9% sodium chloride injection (corresponding to the dose administered according to the body weight at baseline and the dose group) with a total volume of 250 mL, administered as a single intravenous drip at a drip rate recommended by the drug manual on the day of administration, The infusion time is about 90 minutes (± 15 minutes).
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Drug:IASO-782 injection Dosage and Administration: single dose of IASO-782,4mg/kg ，6 mg/kg or 10 mg/kg , intravenous injection at day 1,day 8 and day15. Receives: Drug: IASO-782 injection |
| Control group | Placebo comparator | Drug:placebo Dosage and Administration: single dose of placebo, intravenous injection at day 1,day 8 and day 15. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with adverse events as assessed by CTCAE v6.0
The safety and tolerability of IASO-782 will be assessed primarily by summarizing treatment-emergent AEs and SAEs.
Measured: up to 25 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2026
- Study start26 May 2026
- Primary completion31 Aug 2027 (estimated)
- Study completion31 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SLE - Systemic Lupus ErythematosusStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai IASO Biotechnology Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07483346
- Sponsor's protocol ID
- IASO-782C004
- Status last verified
- Aug 2026
- First submitted
- 16 Mar 2026
- Last updated
- 10 Aug 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 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ib Study to the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of IASO-782 in Patient With Systemic Lupus Erythematosus
- ClinicalTrials.gov ID
- NCT07483346
- Acronym / sponsor ID
- IASO-782C004
- Conditions
- SLE - Systemic Lupus Erythematosus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Shanghai IASO Biotechnology Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 26 May 2026 (actual)
- Primary completion
- 31 Aug 2027 (estimated)
- Study completion
- 31 May 2028 (estimated)
- First posted
- 19 Mar 2026 (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.
his study is a randomized, double-blinded, and placebo-controlled phase Ia clinical study in subjects with SLE. The study is designed to assess the safety and tolerability of IASO-782 for the treatment of SLE.
Detailed description
This study is a multiple-dose escalation study in subjects with SLE. The study is designed to enroll subjects with SLE. This study will evaluate the safety and preliminary dose range of IASO-782 in subjects with SLE at the following dose levels:4mg/kg，6mg/kg and 10mg/kg.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Drug: IASO-782 injectionDrug:IASO-782 injection Dosage and Administration: single dose of IASO-782,4mg/kg ，6 mg/kg or 10 mg/kg , intravenous injection at day 1,day 8 and day15. |
| Control group | Placebo comparator | Drug: PlaceboDrug:placebo Dosage and Administration: single dose of placebo, intravenous injection at day 1,day 8 and day 15. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Aged 18 to 75 years;
- Clinically confirmed diagnosis of SLE before screening;
- Currently receiving standard treatment regimens, including any single drug or combination of drugs;
- Organ function or laboratory test is basically normal;
- Subjects with potential fertility and their partners must use effective contraceptive measures for at least 2 weeks before the first dose of the study drug, throughout the study period, and for 6 months after the end of the study (or early termination of the study);
Key exclusion criteria (14 listed)
- History of other primary malignant neoplasm within 5 years of screening;
- A history of cardiac disease within the recent 3 months, including New York Heart Association (NYHA) Class III/IV congestive heart failure and cardiac arrhythmias requiring drug treatment;
- Subjects with poorly controlled hypertension despite drug treatment;
- A history of hypersensitivity to any component of the study drug or its excipients confirmed before screening;
- Presence of active infection requiring intravenous drug treatment within 30 days before screening;
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 |
|---|---|---|
| IASO-782 injectionEach subject will be given only one dose of IASO-782. Subjects should avoid strenuous exercise within 48 h before administration and remain seated or semi-recumbent (except for necessary activities) for 4 h after administration. IASO-782 solution for injection or placebo was diluted in 0.9% sodium chloride injection (corresponding to the dose administered according to the body weight at baseline and the dose group) with a total volume of 250 mL, administered as a single intravenous drip at a drip rate recommended by the drug manual on the day of administration, The infusion time is about 90 minutes (± 15 minutes). | Drug | Experimental group |
| PlaceboEach subject will be given one dose of placebo. Subjects should avoid strenuous exercise within 48 h before administration and remain seated or semi-recumbent (except for necessary activities) for 4 h after administration. IASO-782 solution for injection or placebo was diluted in 0.9% sodium chloride injection (corresponding to the dose administered according to the body weight at baseline and the dose group) with a total volume of 250 mL, administered as a single intravenous drip at a drip rate recommended by the drug manual on the day of administration, The infusion time is about 90 minutes (± 15 minutes). | Drug | Control group |
Primary outcome
Number of participants with adverse events as assessed by CTCAE v6.0
Time frame: up to 25 weeks
The safety and tolerability of IASO-782 will be assessed primarily by summarizing treatment-emergent AEs and SAEs.
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 10 Aug 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.
Affiliated Hangzhou First People's Hospital, Westlake University, School of Medicine
Hangzhou, China
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, China
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing IASO-782 injection in people with SLE - Systemic Lupus Erythematosus, run by Shanghai IASO Biotechnology Co., Ltd at 4 sites 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 7 inclusion and 14 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: looking for participants now, as of the sponsor's last update on 10 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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. Some participants in this study may receive a placebo. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with adverse events as assessed by CTCAE v6.0 (time frame: up to 25 weeks). 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 10 Aug 2026.