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
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.