RecruitingPhase 1NCT07323173
A Phase I Study to Assess LBL-047 in Healthy Adults and Patients 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
Sponsor
Nanjing Leads Biolabs Co.,Ltd
Enrollment
112 participants
Start Date
Dec 16, 2025
Study Type
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Min Age: 18 YearsMax Age: 60 Years
Inclusion Criteria6
- 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.
- Age ≥ 18 and ≤ 60 years at the time of signing the ICF.
- 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 Criteria9
- 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 A:Abnormalities with clinical significance were indicated by vital signs, physical examination, laboratory test, 12-lead electrocardiogram (ECG), chest X-ray, and abdominal ultrasound.
- Part B:History of organ transplant or hematopoietic stem cell/bone marrow transplant.
- 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).
- 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.
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Interventions
DRUGLBL-047 for Injection
Single subcutaneous injection
DRUGLBL-047 placebo for injection
Single subcutaneous injection
Locations(11)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07323173
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