NCT07323173RecruitingPhase 1
A Study to Assess the Safety and PK/PD of LBL-047 in Healthy Adults and Patients With Systemic Lupus Erythematosus
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
Source: ClinicalTrials.gov · Last updated 21 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 117 (estimated)
- First submitted
- 29 Nov 2025
- Start date
- Dec 2025
- Primary completion date
- Dec 2027
- Lead sponsor
- Nanjing Leads Biolabs Co.,Ltd
- Diseases
- Lupus (SLE)
- NCT number
- NCT07323173
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 117
- From Dec 2025 to the primary completion date, Dec 2027
- 12 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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).
Other illness
- 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 B:History of organ transplant or hematopoietic stem cell/bone marrow transplant.
- 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.
Lab values
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to 60 years · Sex: All · Accepts healthy volunteers
Sites (12)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Beijing GoBroad Hospital Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
| The First Affiliated Hospital of Bengbu Medical University Coordinator of this site? Confirm its status | Bengbu | China | Recruiting |
| Xiangya School of Medicine of Central South University Coordinator of this site? Confirm its status | Changsha | China | Recruiting |
| West China Hospital of Sichuan University Coordinator of this site? Confirm its status | Chengdu | China | Recruiting |
| Sun Yat-sen Memorial Hospital, Sun Yat-sen University Coordinator of this site? Confirm its status | Guangzhou | China | Recruiting |
| Mianyang Central Hospital Coordinator of this site? Confirm its status | Mianyang | China | Recruiting |
| Nanjing Drum Tower hospital Coordinator of this site? Confirm its status | Nanjing | China | Recruiting |
| Pingxiang People's Hospital Coordinator of this site? Confirm its status | Pingxiang | China | Recruiting |
| Shanghai Jiaotong University School of Medicine, Renji Hospital Coordinator of this site? Confirm its status | Shanghai | China | Not yet recruiting |
| Shanghai Public Health Clinical Center Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
| Shanxi Bethune Hospital Coordinator of this site? Confirm its status | Taiyuan | China | Recruiting |
| The Second Affiliated Hospital of Xian Jiaotong University Coordinator of this site? Confirm its status | Xian | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.