Testing a single subcutaneous injection of LBL-047 in healthy adults and people 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

This will test whether a single under-the-skin injection of LBL-047 is safe and shows early benefit for healthy adults and adults with mild to moderate systemic lupus erythematosus.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 112 (estimated)
• Ages: 18 Years to 60 Years
• Sex: All
• Sponsor: Nanjing Leads Biolabs Co.,Ltd (Industry-sponsored)
• Locations: 11 sites (Bengbu, Anhui and 10 other locations)
• Trial ID: NCT07323173 on ClinicalTrials.gov

What this trial studies

This is a double-blind, randomized, placebo-controlled Phase I dose-escalation program conducted in two parts. Part A enrolls healthy adults across seven escalating dose groups who are randomized to a single subcutaneous injection of LBL-047 or placebo with dose escalation guided by a Safety Monitoring Committee, and will collect safety, tolerability, PK, PD and immunogenicity data. Part B enrolls adults with mild to moderate SLE (SLEDAI-2K 4–10) and will begin at doses shown to be safe in Part A to explore preliminary clinical efficacy after a single injection. The study plans to enroll about 76 participants with a possible addition of up to 36 participants.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18–60 who are either healthy volunteers for the dose-escalation part or adults with mild to moderate SLE (SLEDAI-2K 4–10) who can attend visits and follow contraception requirements.

Not a fit: Patients with severe or unstable SLE, pregnant or breastfeeding women, those outside the 18–60 age range, or anyone unwilling to use required contraception are unlikely to be eligible or to benefit.

Why it matters

Potential benefit: If successful, LBL-047 could become a new, well-tolerated biologic option that reduces lupus disease activity with a single injection.

How similar studies have performed: Other biologic therapies targeting immune pathways have shown benefit in SLE, but LBL-047 is a novel agent and its clinical efficacy has not yet been established.

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.

Where this trial is running

Bengbu, Anhui and 10 other locations

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

Study contacts

• Principal investigator: xianmin meng — Shanghai Public Health Clinical Center
• Study coordinator: lei liu

Conditions Systemic Lupus Erythematosus