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

Recruiting now · Phase 1 · Has a placebo group

Conditions studied: Systemic Lupus Erythematosus

In brief

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.

Key facts

Study ID

NCT07323173

Run by

Nanjing Leads Biolabs Co.,Ltd

People needed

112

Starts

2025-12-16

Expected to finish

2027-12-16

Last updated by the study team

2026-04-14

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.
• Age ≥ 18 and ≤ 60 years at the time of signing the ICF.
• 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.

Where it is running

• Shanghai Public Health Clinical Center — Shanghai, Shanghai Municipality, China (enrolling)
• Sun Yat-sen Memorial Hospital, Sun Yat-sen University — Guangzhou, Guangdong, China
• Xiangya School of Medicine of Central South University — Changsha, Hunan, China
• Nanjing Drum Tower Hospital — Nanjing, Jiangsu, China
• Pingxiang People's Hospital — Pingxiang, Jiangxi, China
• Shanghai JiaoTong University School of Medicine，Renji Hospital — Shanghai, Shanghai Municipality, China
• Shanxi Bethune Hospital — Taiyuan, Shanxi, China
• The Second Affiliated Hospital of Xian Jiaotong University — Xian, Shanxi, China
• West China Hospital of Sichuan University — Chengdu, Sichuan, China
• The First Affiliated Hospital of Bengbu Medical University — Bengbu, Anhui, China
• Mianyang Central Hospital — Mianyang, Sichuan, China

Full record on ClinicalTrials.gov

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