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New treatment option for Systemic Lupus Erythematosus
Official title A Phase I Study to Assess LBL-047 in Healthy Adults and Patients With Systemic Lupus Erythematosus
ClinicalTrials.gov ID: NCT07323173
What this study is testing
What is LBL-047 for Injection?
LBL-047 for Injection is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for systemic lupus erythematosus.
Also referred to as LBL-047.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 60. Healthy volunteers may be eligible.
You may be able to join if
- Voluntarily sign and date the informed consent form (ICF) and be willing and able to comply with the scheduled visits, treatment plan, laboratory...
- 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...
You likely can't join if
- Part A:Symptoms or history of any significant disease, including but not limited to cardiovascular, hepatic, renal or any other disease that may...
- Part A:Abnormalities with clinical significance were indicated by vital signs, physical examination, laboratory test, 12-lead electrocardiogram...
- 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...
- 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...
See the full eligibility 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...
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Bengbu, Anhui, China
- Guangzhou, Guangdong, China
- Changsha, Hunan, China
- Nanjing, Jiangsu, China
- Pingxiang, Jiangxi, China
- Shanghai, Shanghai Municipality, China
- Taiyuan, Shanxi, China
- Xian, Shanxi, China
- Chengdu, Sichuan, China
- Mianyang, Sichuan, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 60 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bengbu, Anhui, China; Guangzhou, Guangdong, China; Changsha, Hunan, China; Nanjing, Jiangsu, China; Pingxiang, Jiangxi, China; Shanghai, Shanghai Municipality, China and 4 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.