A Phase I Study to Assess LBL-047 in Healthy Adults and Patients With Systemic Lupus Erythematosus

April 9, 2026 updated by: Nanjing Leads Biolabs Co.,Ltd

A Phase I, Double-Blind, Randomized, Placebo-Controlled, Dose-Escalation Study of Single Subcutaneous Injections of LBL-047 in Healthy Adults and Patients With Systemic Lupus Erythematosus

A Phase I, Double-Blind, Randomized, Placebo-Controlled, Dose-Escalation Study of Single Subcutaneous Injections of LBL-047 in Healthy Adults and Patients with systemic lupus erythematosus.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a double-blind, randomized, placebo-controlled Phase I study to evaluate the safety, tolerability, PK, PD and immunogenicity of a single subcutaneous injection of LBL-047 in healthy adults and patients with systemic lupus erythematosus,the preliminary clinical efficacy of LBL-047 will also be evaluated in patients with systemic lupus erythematosus.

The study is divided into two parts.

Part A:Conduct studies in healthy adults.Part A is planned to be set up with 7 escalating dose groups.Participants were randomized to receive a single subcutaneous injection of LBL-047 or placebo.Dose escalation will be decided by the Safety Monitoring Committee (SMC).

Part B:Study in adult patients with systemic lupus erythematosus.Part B will be initiated at the dose levels that were confirmed to be safe and tolerable in Part A.Part B is planned to enroll patients with mild to moderate systemic lupus erythematosus and receive a single subcutaneous injection of LBL-047.

This study is expected to enroll 76 participants (with possible addition of 36 participants).

Study Type

Interventional

Enrollment (Estimated)

112

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Anhui
      • Bengbu, Anhui, China, 233004
        • Not yet recruiting
        • The First Affiliated Hospital of Bengbu Medical University
        • Contact:
    • Guangdong
      • Guangzhou, Guangdong, China, 510120
        • Not yet recruiting
        • Sun Yat-sen Memorial Hospital, Sun Yat-sen University
        • Contact:
    • Hunan
      • Changsha, Hunan, China, 410028
        • Not yet recruiting
        • Xiangya School of Medicine of Central South University
        • Contact:
    • Jiangsu
      • Nanjing, Jiangsu, China, 210008
        • Not yet recruiting
        • Nanjing Drum Tower Hospital
        • Contact:
    • Jiangxi
      • Pingxiang, Jiangxi, China, 337099
        • Not yet recruiting
        • Pingxiang People's Hospital
        • Contact:
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200083
        • Recruiting
        • Shanghai Public Health Clinical Center
        • Contact:
      • Shanghai, Shanghai Municipality, China, 200001
        • Not yet recruiting
        • Shanghai JiaoTong University School of Medicine，Renji Hospital
        • Contact:
    • Shanxi
      • Taiyuan, Shanxi, China, 030032
        • Not yet recruiting
        • Shanxi Bethune Hospital
        • Contact:
      • Xian, Shanxi, China, 710004
        • Not yet recruiting
        • The Second Affiliated Hospital of Xian Jiaotong University
        • Contact:
    • Sichuan
      • Chengdu, Sichuan, China, 610041
        • Not yet recruiting
        • West China Hospital of Sichuan University
        • Contact:
      • Mianyang, Sichuan, China, 621051
        • Not yet recruiting
        • Mianyang Central Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Voluntarily sign and date the informed consent form (ICF) and be willing and able to comply with the scheduled visits, treatment plan, laboratory test, and other study procedures.
  2. Age ≥ 18 and ≤ 60 years at the time of signing the ICF.
  3. Part A:Determined by the investigator to be in good health at the time of signing the ICF.
  4. Part B:Mild to moderate systemic lupus erythematosus: SLEDAI-2K score ≥4 and ≤ 10 at screening.
  5. 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.
  6. 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.

Exclusion Criteria:

  1. 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.
  2. 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.
  3. Part B:History of organ transplant or hematopoietic stem cell/bone marrow transplant.
  4. Part B:currently receiving treatment for any chronic infection (such as pneumocystosis, cytomegalovirus, herpes simplex virus, herpes zoster and atypical mycobacteriosis).
  5. Major surgery (as judged by the investigator) within 90 days prior to dosing, or surgery scheduled during the study.
  6. 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).
  7. Large tattoo, scar or other condition that may interfere with assessment at the injection site.
  8. unable to tolerate venipuncture, difficulty in blood collection or has a history of needle/blood phobic disorder.
  9. The investigator determines that there are other conditions unsuitable for participation in this study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: LBL-047 for Injection
LBL-047 for Injection,Single subcutaneous injection.
Drug: LBL-047 for Injection
Single subcutaneous injection
Other Names:
  • LBL-047
Active Comparator: LBL-047 placebo for injection
LBL-047 placebo for injection,Single subcutaneous injection.
Drug: LBL-047 placebo for injection
Single subcutaneous injection
Other Names:
  • LBL-047 placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Occurrence of Treatment-Emergent adverse event (TEAE) and serious adverse event (SAE)
Time Frame: From first dose until last visit(within 85 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.
From first dose until last visit(within 85 days after drug injection)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cmax
Time Frame: From first dose until last visit(within 85 days after drug injection)
Maximum drug concentration in plasma after administration.
From first dose until last visit(within 85 days after drug injection)
Tmax
Time Frame: From first dose until last visit(within 85 days after drug injection)
After administration,Time to reach maximum drug concentration in plasma.
From first dose until last visit(within 85 days after drug injection)
Immunogenicity
Time Frame: From first dose until last visit(within 85 days after drug injection)
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.
From first dose until last visit(within 85 days after drug injection)
Assessment of Pharmacodynamics
Time Frame: From first dose until last visit(within 85 days after drug injection)
Drug therapy effect and adverse reaction, such as B cell level.
From first dose until last visit(within 85 days after drug injection)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nanjing Leads Biolabs Co.,Ltd

Collaborators

RenJi Hospital
Shanghai Public Health Clinical Center

Investigators

  • Principal Investigator: xianmin meng, Shanghai Public Health Clinical Center
  • Principal Investigator: shuang ye, RenJi Hospital
  • Principal Investigator: sheng chen, RenJi Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 16, 2025

Primary Completion (Estimated)

December 16, 2027

Study Completion (Estimated)

December 16, 2027

Study Registration Dates

First Submitted

November 29, 2025

First Submitted That Met QC Criteria

December 23, 2025

First Posted (Actual)

January 7, 2026

Study Record Updates

Last Update Posted (Actual)

April 14, 2026

Last Update Submitted That Met QC Criteria

April 9, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LBL-047-CN001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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