A Study to Assess the Safety and PK/PD of LBL-047 in Healthy Adults and Patients With Systemic Lupus Erythematosus

NCT07323173 | Recruiting Phase 1 DMC

• 1 other identifier: LBL-047-CN001
• Study Type: interventional
• Target: 117
• Locations: 1 country
• Sites: 12

Brief 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.

Conditions

Systemic Lupus Erythematosus

Outcome Measures

Primary Outcomes (1)

• 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.

  From first dose until last visit(within 89 days after drug injection)

Secondary Outcomes (4)

• Cmax

  From first dose until last visit(within 89 days after drug injection)

• Tmax

  From first dose until last visit(within 89 days after drug injection)

• Immunogenicity

  From first dose until last visit(within 89 days after drug injection)

• Assessment of Pharmacodynamics

  From first dose until last visit(within 89 days after drug injection)

Study Arms (2)

LBL-047 for Injection

EXPERIMENTAL

LBL-047 for Injection subcutaneous injection.

Drug: LBL-047 for Injection

LBL-047 placebo for injection

ACTIVE COMPARATOR

LBL-047 placebo for injection subcutaneous injection.

Drug: LBL-047 placebo for injection

Interventions

LBL-047 for Injection DRUG

subcutaneous injection

Also known as: LBL-047

LBL-047 for Injection

LBL-047 placebo for injection DRUG

subcutaneous injection

Also known as: LBL-047 placebo

LBL-047 placebo for injection

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).
• 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.

Sponsors & Collaborators

• Nanjing Leads Biolabs Co.,Ltd: lead
• RenJi Hospital: collaborator
• Shanghai Public Health Clinical Center: collaborator

Study Sites (12)

The First Affiliated Hospital of Bengbu Medical University

Bengbu, Anhui, 233004, China

NOT YET RECRUITING

Beijing GoBroad Hospital

Beijing, Beijing Municipality, 102200, China

NOT YET RECRUITING

Sun Yat-sen Memorial Hospital, Sun Yat-sen University

Guangzhou, Guangdong, 510120, China

RECRUITING

Xiangya School of Medicine of Central South University

Changsha, Hunan, 410028, China

NOT YET RECRUITING

Nanjing Drum Tower Hospital

Nanjing, Jiangsu, 210008, China

NOT YET RECRUITING

Pingxiang People's Hospital

Pingxiang, Jiangxi, 337099, China

RECRUITING

Shanghai JiaoTong University School of Medicine，Renji Hospital

Shanghai, Shanghai Municipality, 200001, China

NOT YET RECRUITING

Shanghai Public Health Clinical Center

Shanghai, Shanghai Municipality, 200083, China

RECRUITING

Shanxi Bethune Hospital

Taiyuan, Shanxi, 030032, China

NOT YET RECRUITING

The Second Affiliated Hospital of Xian Jiaotong University

Xian, Shanxi, 710004, China

RECRUITING

West China Hospital of Sichuan University

Chengdu, Sichuan, 610041, China

RECRUITING

Mianyang Central Hospital

Mianyang, Sichuan, 621051, China

RECRUITING

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Interventions

Injections

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• xianmin meng

  Shanghai Public Health Clinical Center

  PRINCIPAL INVESTIGATOR

• shuang ye

  RenJi Hospital

  PRINCIPAL INVESTIGATOR

• sheng chen

  RenJi Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

lei liu

CONTACT

025-83378099; liulei@leadsbiolabs.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 29, 2025
• First Posted: January 7, 2026
• Study Start: December 16, 2025
• Primary Completion (Estimated): December 16, 2027
• Study Completion (Estimated): December 16, 2027
• Last Updated: August 27, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (12)