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

NCT ID: NCT07323173

Last Updated: 2026-01-07

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 112 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-16
• Study Completion Date: 2027-12-16

Brief Summary

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.

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).

Conditions

Systemic Lupus Erythematosus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

LBL-047 for Injection

LBL-047 for Injection,Single subcutaneous injection.

Group Type: EXPERIMENTAL

LBL-047 for Injection

Intervention Type: DRUG

Single subcutaneous injection

LBL-047 placebo for injection

LBL-047 placebo for injection,Single subcutaneous injection.

Group Type: ACTIVE_COMPARATOR

LBL-047 placebo for injection

Intervention Type: DRUG

Single subcutaneous injection

Interventions

LBL-047 for Injection

Single subcutaneous injection

Intervention Type: DRUG

LBL-047 placebo for injection

Single subcutaneous injection

Intervention Type: DRUG

Other Intervention Names

LBL-047; LBL-047 placebo

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Shanghai Public Health Clinical Center

OTHER_GOV

Sponsor Role: collaborator

Nanjing Leads Biolabs Co.,Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

xianmin meng

Role: PRINCIPAL_INVESTIGATOR

Shanghai Public Health Clinical Center

Locations

Shanghai Public Health Clinical Center

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

xianmin meng

Role: CONTACT

liulei@leadsbiolabs.com

021-37990333

Facility Contacts

lei liu

Role: primary

liulei@leadsbiolabs.com

025-83378099

Other Identifiers

LBL-047-CN001

Identifier Type: -

Identifier Source: org_study_id