NCT07323173 A Phase I Study to Assess LBL-047 in Healthy Adults and Patients With Systemic Lupus Erythematosus
| NCT ID | NCT07323173 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Nanjing Leads Biolabs Co.,Ltd |
| Condition | Systemic Lupus Erythematosus |
| Study Type | INTERVENTIONAL |
| Enrollment | 112 participants |
| Start Date | 2025-12-16 |
| Primary Completion | 2027-12-16 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 112 participants in total. It began in 2025-12-16 with a primary completion date of 2027-12-16.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: 1. 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. 2. Age ≥ 18 and ≤ 60 years at the time of signing the ICF. 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.
Contact & Investigator
xianmin meng
PRINCIPAL INVESTIGATOR
Shanghai Public Health Clinical Center
Frequently Asked Questions
Who can join the NCT07323173 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 60 Years, studying Systemic Lupus Erythematosus. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07323173 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07323173 currently recruiting?
Yes, NCT07323173 is actively recruiting participants. Contact the research team at liulei@leadsbiolabs.com for enrollment information.
Where is the NCT07323173 trial being conducted?
This trial is being conducted at Bengbu, China, Guangzhou, China, Changsha, China, Nanjing, China and 7 additional locations.
Who is sponsoring the NCT07323173 clinical trial?
NCT07323173 is sponsored by Nanjing Leads Biolabs Co.,Ltd. The principal investigator is xianmin meng at Shanghai Public Health Clinical Center. The trial plans to enroll 112 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.