RecruitingPhase 1

A Phase I Study to Assess LBL-047 in Healthy Adults and Patients With Systemic Lupus Erythematosus

China112 participantsStarted 2025-12-16

Plain-language 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.

Who can participate

Age range18 Years – 60 Years

SexALL

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Inclusion criteria

✓. 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 criteria

✕. 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.

What they're measuring

Occurrence of Treatment-Emergent adverse event (TEAE) and serious adverse event (SAE)

Timeframe: From first dose until last visit(within 85 days after drug injection)

Trial details

NCT IDNCT07323173

SponsorNanjing Leads Biolabs Co.,Ltd

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-12-16

Contact for this trial

lei liu

025-83378099 liulei@leadsbiolabs.com

View on ClinicalTrials.gov More Systemic Lupus Erythematosus trials