A Double-blind, Randomized, Placebo-controlled, Dose-escalation Phase I Study to Assess the Safety and PK/PD of LBL-047 Subcutaneous Injection in Healthy Adults and Patients With Systemic Lupus Erythematosus
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 117
- 试验地点
- 17
- 主要终点
- Occurrence of Treatment-Emergent adverse event (TEAE) and serious adverse event (SAE)
研究概览
简要总结
A Double-blind, Randomized, Placebo-controlled, Dose-escalation Phase I Study to Assess the Safety and PK/PD of LBL-047 Subcutaneous Injection in Healthy Adults and Patients with Systemic Lupus Erythematosus.
详细描述
This study is a double-blind, randomized, placebo-controlled phase I clinical study to evaluate the safety, tolerability, PK, PD and immunogenicity of LBL-047 subcutaneously administered in healthy adults and subjects with systemic lupus erythematosus, while also preliminarily evaluating the clinical efficacy of LBL-047 in subjects with systemic lupus erythematosus.
The study is divided into two parts.
Part A: Study in healthy adults.A total of 7 dose-escalation cohorts were planned for Part A.Dose escalation will be determined by the Safety Monitoring Committee (SMC).
Part B: Study in Adult Patients with Systemic Lupus Erythematosus.Part B will commence at a dose level that has been confirmed to be safe and tolerable in Part A.
This study is projected to enroll 81 participants (potentially with an additional 36).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
- •Age 18-60 years (inclusive of boundaries) at the time of signing informed consent form.
- •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.
排除标准
- •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.
研究组 & 干预措施
LBL-047 for Injection
LBL-047 for Injection,Single subcutaneous injection.
干预措施: LBL-047 for Injection (Drug)
LBL-047 placebo for injection
LBL-047 placebo for injection,Single subcutaneous injection.
干预措施: LBL-047 placebo for injection (Drug)
结局指标
主要结局
Occurrence of Treatment-Emergent adverse event (TEAE) and serious adverse event (SAE)
时间窗: From first dose until last visit(within 89 days after drug injection)
Adverse event (AE) will be graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) 5.0.The safety profile of LBL-047 will be assessed by monitoring the adverse event (AE) and serious adverse event (SAE) During treatment.
Occurrence of Treatment-Emergent adverse event (TEAE) and serious adverse event (SAE)
时间窗: From first dose until last visit(within 85 days after drug injection)
Adverse event (AE) will be graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) 5.0.The safety profile of LBL-047 will be assessed by monitoring the adverse event (AE) and serious adverse event (SAE) During treatment.
次要结局
- Cmax(From first dose until last visit(within 89 days after drug injection))
- Tmax(From first dose until last visit(within 89 days after drug injection))
- Immunogenicity(From first dose until last visit(within 89 days after drug injection))
- Assessment of Pharmacodynamics(From first dose until last visit(within 89 days after drug injection))
- Cmax(From first dose until last visit(within 85 days after drug injection))
- Tmax(From first dose until last visit(within 85 days after drug injection))
- Immunogenicity(From first dose until last visit(within 85 days after drug injection))
- Assessment of Pharmacodynamics(From first dose until last visit(within 85 days after drug injection))