Tests LBL-047 injection for safety in lupus and healthy adults
Tests LBL-047 injection under the skin in healthy adults and adults with lupus.
Plain-language title generated from the registry record
Registry title: A Study to Assess the Safety and PK/PD of LBL-047 in Healthy Adults and Patients With Systemic Lupus Erythematosus
Key facts
- Where
- Beijing, Bengbu, Changsha, Chengdu, Guangzhou, Mianyang, Nanjing, Pingxiang, Shanghai, Taiyuan, and Xian, ChinaSee the 12 sites
- Phase
- Phase 1
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for healthy adults (Part A) and adults with mild to moderate systemic lupus erythematosus (Part B) to test the safety of LBL-047 given as an injection under the skin.
- Age
- 18 to 60 years
- Sex
- All sexes
- Disease stage
- Part B: mild to moderate systemic lupus erythematosus, SLEDAI-2K score from 4 to 10 at screening. Part A: good health.
- Earlier treatment
- Part B: cannot be currently treated for a chronic infection. No organ or stem cell/bone marrow transplant in the past.
Main reasons for not taking part
- Part A: any significant disease or clinically significant abnormal test results
- Part B: history of organ, stem cell or bone marrow transplant
- Part B: currently treated for a chronic infection
- Major surgery within 90 days before dosing, or surgery planned during the study
- Positive pregnancy test at screening
Read by machine on 9 November 2026.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 60 years old?
Source: NCT07323173, who can take part
Where in China
- Beijing GoBroad HospitalBeijing, ChinaTaking people
- The First Affiliated Hospital of Bengbu Medical UniversityBengbu, ChinaTaking people
- Xiangya School of Medicine of Central South UniversityChangsha, ChinaTaking people
- West China Hospital of Sichuan UniversityChengdu, ChinaTaking people
- Sun Yat-sen Memorial Hospital, Sun Yat-sen UniversityGuangzhou, ChinaTaking people
- Mianyang Central HospitalMianyang, ChinaTaking people
- Nanjing Drum Tower hospitalNanjing, ChinaTaking people
- Pingxiang People's HospitalPingxiang, ChinaTaking people
- Shanghai Jiaotong University School of Medicine, Renji HospitalShanghai, ChinaNot yet recruiting
- Shanghai Public Health Clinical CenterShanghai, ChinaTaking people
- Shanxi Bethune HospitalTaiyuan, ChinaTaking people
- The Second Affiliated Hospital of Xian Jiaotong UniversityXian, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Nanjing Leads Biolabs Co.,Ltd
- Trial code
- NCT07323173
- Record updated
- 21 October 2026
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: 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.
Exclusion: 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); 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; 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.