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Clinical Trials in China / NCT07323173
Recruiting Phase 1

A Study to Assess the Safety and PK/PD of LBL-047 in Healthy Adults and Patients With Systemic Lupus Erythematosus

NCT07323173 · tracked via the Priya Life Science China tracker
Sponsor
Nanjing Leads Biolabs Co.,Ltd
Phase
Phase 1
Started
2025-12-16
Last updated
2026-08-27

Condition(s) studied

Systemic Lupus Erythematosus

Investigational drug(s) / intervention(s)

LBL-047 for InjectionLBL-047 placebo for injection

LBL-047 for Injection: subcutaneous injection

LBL-047 placebo for injection: subcutaneous injection

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
60 Years
Healthy volunteers
Accepted
Inclusion Criteria: 1. 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. 2. Age 18-60 years (inclusive of boundaries) at the time of signing informed consent form. 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.

Primary outcome measure(s)

Trial sites (12)

FacilityCityRegionStatus
The First Affiliated Hospital of Bengbu Medical University Bengbu Anhui Not Yet Recruiting
Beijing GoBroad Hospital Beijing Beijing Municipality Not Yet Recruiting
Sun Yat-sen Memorial Hospital, Sun Yat-sen University Guangzhou Guangdong Recruiting
Xiangya School of Medicine of Central South University Changsha Hunan Not Yet Recruiting
Nanjing Drum Tower Hospital Nanjing Jiangsu Not Yet Recruiting
Pingxiang People's Hospital Pingxiang Jiangxi Recruiting
Shanghai JiaoTong University School of Medicine,Renji Hospital Shanghai Shanghai Municipality Not Yet Recruiting
Shanghai Public Health Clinical Center Shanghai Shanghai Municipality Recruiting
Shanxi Bethune Hospital Taiyuan Shanxi Not Yet Recruiting
The Second Affiliated Hospital of Xian Jiaotong University Xian Shanxi Recruiting
West China Hospital of Sichuan University Chengdu Sichuan Recruiting
Mianyang Central Hospital Mianyang Sichuan Recruiting

More Nanjing Leads Biolabs Co.,Ltd trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07323173 on ClinicalTrials.gov ↗ ← All trials in China