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
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).
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- 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.
- 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