Testing a single subcutaneous injection of LBL-047 in healthy adults and people with systemic lupus erythematosus

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a double-blind, randomized, placebo-controlled Phase I dose-escalation program conducted in two parts. Part A enrolls healthy adults across seven escalating dose groups who are randomized to a single subcutaneous injection of LBL-047 or placebo with dose escalation guided by a Safety Monitoring Committee, and will collect safety, tolerability, PK, PD and immunogenicity data. Part B enrolls adults with mild to moderate SLE (SLEDAI-2K 4–10) and will begin at doses shown to be safe in Part A to explore preliminary clinical efficacy after a single injection. The study plans to enroll about 76 participants with a possible addition of up to 36 participants.

Why it matters

Who can join: the full rules

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.

Where it's running

• The First Affiliated Hospital of Bengbu Medical University
  Bengbu, Anhui, China Recruiting
• Beijing GoBroad Hospital
  Beijing, Beijing Municipality, China Recruiting
• Sun Yat-sen Memorial Hospital, Sun Yat-sen University
  Guangzhou, Guangdong, China Recruiting
• Xiangya School of Medicine of Central South University
  Changsha, Hunan, China Recruiting
• Nanjing Drum Tower Hospital
  Nanjing, Jiangsu, China Recruiting
• Pingxiang People's Hospital
  Pingxiang, Jiangxi, China Recruiting

Study contacts

• Principal investigator: xianmin meng — Shanghai Public Health Clinical Center
• Study coordinator: lei liu
• Email: liulei@leadsbiolabs.com
• Phone: 025-83378099

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.