Systemic Lupus ErythematosusPhase 1NCT07323173
A Study to Assess the Safety and PK/PD of LBL-047 in Healthy Adults and Patients With Systemic Lupus Erythematosus
A Phase 1 study testing LBL-047 for Injection in people with Systemic Lupus Erythematosus, run by Nanjing Leads Biolabs Co.,Ltd at 12 sites in China.
Trial summary
A Double-blind, Randomized, Placebo-controlled, Dose-escalation Phase I Study to Assess the Safety and PK/PD of LBL-047 Subcutaneous Injection in Healthy Adults and Patients with Systemic Lupus Erythematosus. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Systemic Lupus Erythematosus
- What is being tested?
- LBL-047 for Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 117 participants
- Where
- 12 sitesChina
- Study dates
- 16 Dec 2025to 16 Dec 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 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Agree to follow the trial treatment regimen, visit schedule, laboratory test, and other requirements of the protocol, and voluntarily enroll in the study and sign the written informed consent.
- Age 18-60 years (inclusive of boundaries) at the time of signing informed consent form.
- Part A:Determined by the investigator to be in good health at the time of signing the ICF.
- Part B:Mild to moderate systemic lupus erythematosus: SLEDAI-2K score ≥4 and ≤ 10 at screening.
- Females of childbearing potential are willing to use highly effective contraception during the study and for 6 months after administration of the study drug and to avoid egg donation.Women of non-childbearing potential include: those with documented surgical sterilization or documented menopause.
- Male of childbearing potential are willing to use highly effective contraception during the study and for 6 months after study drug administration and to avoid sperm donation.Men without fertility potential include those with: A semen sample investigation that confirms azoospermia, definitive evidence of infertility, or a history of vasoligation.For the purpose of this study, men with a "low sperm count" (or "subfertility") are not considered infertile.
Who cannot join
- Part A:Symptoms or history of any significant disease, including but not limited to cardiovascular, hepatic, renal or any other disease that may interfere with the study results.
- Part A:Abnormalities with clinical significance were indicated by vital signs, physical examination, laboratory test, 12-lead electrocardiogram (ECG), chest X-ray, and abdominal ultrasound.
- Part B:History of organ transplant or hematopoietic stem cell/bone marrow transplant.
- Part B:currently receiving treatment for any chronic infection (such as pneumocystosis, cytomegalovirus, herpes simplex virus, herpes zoster and atypical mycobacteriosis).
- Major surgery (as judged by the investigator) within 90 days prior to dosing, or surgery scheduled during the study.
- At screening, women of childbearing potential were positive for pregnancy.follicle stimulating hormone (FSH) did not reach postmenopausal level in postmenopausal women (defined as amenorrhoea ≥ 12 months before screening).
Show all 9Show fewer
- Large tattoo, scar or other condition that may interfere with assessment at the injection site.
- unable to tolerate venipuncture, difficulty in blood collection or has a history of needle/blood phobic disorder.
- The investigator determines that there are other conditions unsuitable for participation in this study.
Trial locations and contacts
12 sites in 1 country. Contact the study team or a site near you to ask about taking part.
12 sites in 1 country
China12 sites, 12 recruiting
- Recruiting
Beijing GoBroad Hospital
Beijing, Beijing Municipality, 102200
lei liu, 02583378099, liulei@leadsbiolabs.com
- Recruiting
The First Affiliated Hospital of Bengbu Medical University
Bengbu, Anhui, 233004
lei liu, 02583378099, liulei@leadsbiolabs.com
- Recruiting
Xiangya School of Medicine of Central South University
Changsha, Hunan, 410028
lei liu, 02583378099, liulei@leadsbiolabs.com
- Recruiting
West China Hospital of Sichuan University
Chengdu, Sichuan, 610041
lei liu, 02583378099, liulei@leadsbiolabs.com
- Recruiting
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong, 510120
lei liu, 02583378099, liulei@leadsbiolabs.com
- Recruiting
Mianyang Central Hospital
Mianyang, Sichuan, 621051
lei liu, 02583378099, liulei@leadsbiolabs.com
- Recruiting
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, 210008
lei liu, 02583378099, liulei@leadsbiolabs.com
- Recruiting
Pingxiang People's Hospital
Pingxiang, Jiangxi, 337099
lei liu, 02583378099, liulei@leadsbiolabs.com
- Not yet recruiting
Shanghai JiaoTong University School of Medicine，Renji Hospital
Shanghai, Shanghai Municipality, 200001
lei liu, 02583378099, liulei@leadsbiolabs.com
- Recruiting
Shanghai Public Health Clinical Center
Shanghai, Shanghai Municipality, 200083
lei liu, 025-83378099, liulei@leadsbiolabs.com
- Recruiting
Shanxi Bethune Hospital
Taiyuan, Shanxi, 030032
lei liu, 02583378099, liulei@leadsbiolabs.com
- Recruiting
The Second Affiliated Hospital of Xian Jiaotong University
Xian, Shanxi, 710004
lei liu, 02583378099, liulei@leadsbiolabs.com
About this study
Official title: A Double-blind, Randomized, Placebo-controlled, Dose-escalation Phase I Study to Assess the Safety and PK/PD of LBL-047 Subcutaneous Injection in Healthy Adults and Patients With Systemic Lupus Erythematosus
A Double-blind, Randomized, Placebo-controlled, Dose-escalation Phase I Study to Assess the Safety and PK/PD of LBL-047 Subcutaneous Injection in Healthy Adults and Patients with Systemic Lupus Erythematosus.
Read the detailed description
This study is a double-blind, randomized, placebo-controlled phase I clinical study to evaluate the safety, tolerability, PK, PD and immunogenicity of LBL-047 subcutaneously administered in healthy adults and subjects with systemic lupus erythematosus, while also preliminarily evaluating the clinical efficacy of LBL-047 in subjects with systemic lupus erythematosus.
The study is divided into two parts.
Part A: Study in healthy adults.A total of 7 dose-escalation cohorts were planned for Part A.Dose escalation will be determined by the Safety Monitoring Committee (SMC).
Part B: Study in Adult Patients with Systemic Lupus Erythematosus.Part B will commence at a dose level that has been confirmed to be safe and tolerable in Part A.
This study is projected to enroll up to 117 participants.
- Conditions
- Systemic Lupus Erythematosus
- Being tested
- LBL-047 for Injection, LBL-047 placebo for injection
- 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.
LBL-047 for InjectionDrug
Also called LBL-047
subcutaneous injection
LBL-047 placebo for injectionDrug
Also called LBL-047 placebo
subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| LBL-047 for Injection | Experimental | LBL-047 for Injection subcutaneous injection. Receives: Drug: LBL-047 for Injection |
| LBL-047 placebo for injection | Active comparator | LBL-047 placebo for injection subcutaneous injection. Receives: Drug: LBL-047 placebo for injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of Treatment-Emergent adverse event (TEAE) and serious adverse event (SAE)
Adverse event (AE) will be graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) 5.0.The safety profile of LBL-047 will be assessed by monitoring the adverse event (AE) and serious adverse event (SAE) During treatment.
Measured: From first dose until last visit(within 89 days after drug injection)
Secondary outcomes (4)
Cmax
Maximum drug concentration in plasma after administration.
Measured: From first dose until last visit(within 89 days after drug injection)
Tmax
After administration,Time to reach maximum drug concentration in plasma.
Measured: From first dose until last visit(within 89 days after drug injection)
Immunogenicity
The immunogenicity is evaluated by the incidence of anti-drug antibodies (ADA) and neutralizing antibodies (if applicable) in subjects.Immunogenicity refers to the performance that can elicit an immune response.
Measured: From first dose until last visit(within 89 days after drug injection)
Assessment of Pharmacodynamics
Drug therapy effect and adverse reaction, such as B cell level.
Measured: From first dose until last visit(within 89 days after drug injection)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2026
- Study start16 Dec 2025
- Primary completion16 Dec 2027 (estimated)
- Study completion16 Dec 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 ErythematosusStudies of the same condition, open and under way.
- More trials run by Nanjing Leads Biolabs Co.,LtdThe sponsor's other registered studies.
- 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
- 117 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanjing Leads Biolabs Co.,Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Shanghai Public Health Clinical Center, RenJi Hospital
- Responsible party
- Sponsor
- Investigators
- xianmin meng, Principal investigator, Shanghai Public Health Clinical Centershuang ye, Principal investigator, RenJi Hospitalsheng chen, Principal investigator, RenJi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07323173
- Sponsor's protocol ID
- LBL-047-CN001
- Status last verified
- Oct 2026
- First submitted
- 29 Nov 2025
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Randomized, Placebo-controlled, Dose-escalation Phase I Study to Assess the Safety and PK/PD of LBL-047 Subcutaneous Injection in Healthy Adults and Patients With Systemic Lupus Erythematosus
- ClinicalTrials.gov ID
- NCT07323173
- Acronym / sponsor ID
- LBL-047-CN001
- Conditions
- Systemic Lupus Erythematosus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 117 participants (estimated)
- Lead sponsor
- Nanjing Leads Biolabs Co.,LtdIndustry (pharma, biotech, devices)
- Collaborators
- Shanghai Public Health Clinical Center, RenJi Hospital
- Study start
- 16 Dec 2025 (actual)
- Primary completion
- 16 Dec 2027 (estimated)
- Study completion
- 16 Dec 2027 (estimated)
- First posted
- 7 Jan 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.
A Double-blind, Randomized, Placebo-controlled, Dose-escalation Phase I Study to Assess the Safety and PK/PD of LBL-047 Subcutaneous Injection in Healthy Adults and Patients with Systemic Lupus Erythematosus.
Detailed description
This study is a double-blind, randomized, placebo-controlled phase I clinical study to evaluate the safety, tolerability, PK, PD and immunogenicity of LBL-047 subcutaneously administered in healthy adults and subjects with systemic lupus erythematosus, while also preliminarily evaluating the clinical efficacy of LBL-047 in subjects with systemic lupus erythematosus.
The study is divided into two parts.
Part A: Study in healthy adults.A total of 7 dose-escalation cohorts were planned for Part A.Dose escalation will be determined by the Safety Monitoring Committee (SMC).
Part B: Study in Adult Patients with Systemic Lupus Erythematosus.Part B will commence at a dose level that has been confirmed to be safe and tolerable in Part A.
This study is projected to enroll up to 117 participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LBL-047 for Injection | Experimental | Drug: LBL-047 for InjectionLBL-047 for Injection subcutaneous injection. |
| LBL-047 placebo for injection | Active comparator | Drug: LBL-047 placebo for injectionLBL-047 placebo for injection subcutaneous injection. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Agree to follow the trial treatment regimen, visit schedule, laboratory test, and other requirements of the protocol, and voluntarily enroll in the study and sign the written informed consent.
- Age 18-60 years (inclusive of boundaries) at the time of signing informed consent form.
- Part A:Determined by the investigator to be in good health at the time of signing the ICF.
- Part B:Mild to moderate systemic lupus erythematosus: SLEDAI-2K score ≥4 and ≤ 10 at screening.
- Females of childbearing potential are willing to use highly effective contraception during the study and for 6 months after administration of the study drug and to avoid egg donation.Women of non-childbearing potential include: those with documented surgical sterilization or documented menopause.
Key exclusion criteria (9 listed)
- Part A:Symptoms or history of any significant disease, including but not limited to cardiovascular, hepatic, renal or any other disease that may interfere with the study results.
- Part A:Abnormalities with clinical significance were indicated by vital signs, physical examination, laboratory test, 12-lead electrocardiogram (ECG), chest X-ray, and abdominal ultrasound.
- Part B:History of organ transplant or hematopoietic stem cell/bone marrow transplant.
- Part B:currently receiving treatment for any chronic infection (such as pneumocystosis, cytomegalovirus, herpes simplex virus, herpes zoster and atypical mycobacteriosis).
- Major surgery (as judged by the investigator) within 90 days prior to dosing, or surgery scheduled during the study.
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 |
|---|---|---|
| LBL-047 for InjectionAlso: LBL-047subcutaneous injection | Drug | LBL-047 for Injection |
| LBL-047 placebo for injectionAlso: LBL-047 placebosubcutaneous injection | Drug | LBL-047 placebo for injection |
Primary outcome
Occurrence of Treatment-Emergent adverse event (TEAE) and serious adverse event (SAE)
Time frame: From first dose until last visit(within 89 days after drug injection)
Adverse event (AE) will be graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) 5.0.The safety profile of LBL-047 will be assessed by monitoring the adverse event (AE) and serious adverse event (SAE) During treatment.
4 secondary outcomes
Cmax
Time frame: From first dose until last visit(within 89 days after drug injection)
Tmax
Time frame: From first dose until last visit(within 89 days after drug injection)
Immunogenicity
Time frame: From first dose until last visit(within 89 days after drug injection)
Assessment of Pharmacodynamics
Time frame: From first dose until last visit(within 89 days after drug injection)
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 21 Oct 2026.
- Individual participant dataSharing planned: No
Related trials for Systemic Lupus Erythematosus
Not yet recruitingPhase 1
An Ascending Dose Study of DKB903 in Participants With Rheumatoid Arthritis (RA) and Participants With Systemic Lupus Erythematosus (SLE)
Rheumatoid Arthritis and Systemic Lupus Erythematosus
RecruitingPhase 4
Dapagliflozin in Active Lupus Nephritis
Lupus Nephritis (LN)
RecruitingObservational study
Electroencephalogram Recording in Patients With Systemic Lupus Erythematosus
Systemic Lupus Erythematosus
RecruitingObservational study
Deciphering the Genetic Architecture of Autoimmune Diseases
Autoimmune Diseases
RecruitingPhase 1
A Trial in Healthy Adult Participants and Adults With Autoimmune Diseases to Test How HBM7020 is Tolerated and How it Behaves in the Body
Rheumatoid Arthritis, Systemic Lupus Erythematosus
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.
xianmin meng principal investigator
Shanghai Public Health Clinical Center
shuang ye principal investigator
RenJi Hospital
sheng chen principal investigator
RenJi Hospital
12 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 LBL-047 for Injection in people with Systemic Lupus Erythematosus, run by Nanjing Leads Biolabs Co.,Ltd at 12 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 6 inclusion and 9 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 21 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 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. 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 lei liu (025-83378099, liulei@leadsbiolabs.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of Treatment-Emergent adverse event (TEAE) and serious adverse event (SAE) (time frame: From first dose until last visit(within 89 days after drug injection)). 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 21 Oct 2026.