A Phase 1, Double-blind, Randomized, Single Ascending Dose Study of the Safety and Tolerability of MEDI-570 in SLE
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 44
- 试验地点
- 17
- 主要终点
- Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)
研究概览
简要总结
The purpose of this study is to evaluate the safety and tolerability of MEDI-570 in adult subjects with moderately to severely active systemic lupus erythematosus (SLE).
详细描述
This is a Phase 1, double-blind, randomized, placebo-controlled study to evaluate the safety and tolerability of escalating single subcutaneous doses of MEDI-570 in adult subjects with moderately to severely active SLE.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Meet or have met at least 4 of the 11 revised American College of Rheumatology (ACR) classification criteria for systemic lupus erythematosus (SLE)
- •Score greater than or equal to (>=) 6 points on the Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) at Screening
- •Ability to complete the study period, including follow-up period through Day 169
- •Willingness to forego other forms of experimental treatment during the study.
排除标准
- •History of cancer except basal cell carcinoma treated with apparent success with curative therapy >=1 year before randomization into the study
- •Evidence of active or latent tuberculosis (TB)
- •History of primary immunodeficiency
- •Evidence of infection at any time with hepatitis B or C virus or human immunodeficiency virus (HIV)-1 or HIV-2, or active infection with hepatitis A, as determined by results of testing at Screening
- •History of sepsis or serious, recurrent, chronic infection, current signs and symptoms of clinically significant chronic infection, or recent (within 6 months before Baseline visit) serious infection
- •Any history or evidence of opportunistic infection within 6 months of Screening including severe cytomegalovirus (CMV) or herpetic infections (such as disseminated herpes, herpes encephalitis, ophthalmic herpes)
- •Receipt of cyclophosphamide (intravenous or oral) within 6 months of Screening
- •Have any absolute contraindications to skin punch biopsies, for example, a history of coagulation disorders.
研究组 & 干预措施
Placebo
A single double-blind dose of placebo matched to MEDI-570 subcutaneous injection on Day 1.
干预措施: Placebo (Other)
MEDI-570 0.03 MG
A single open-label dose of MEDI-570, 0.03 milligram (mg) subcutaneous injection on Day 1.
干预措施: MEDI-570 0.03 MG (Biological)
MEDI-570 0.1 MG
A single open-label dose of MEDI-570, 0.1 mg subcutaneous injection on Day 1.
干预措施: MEDI-570 0.1 MG (Biological)
MEDI-570 0.3 MG
A single double-blind dose of MEDI-570, 0.3 mg subcutaneous injection on Day 1.
干预措施: MEDI-570 0.3 MG (Biological)
MEDI-570 1 MG
A single double-blind dose of MEDI-570, 1 mg subcutaneous injection on Day 1.
干预措施: MEDI-570 1 MG (Biological)
结局指标
主要结局
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)
时间窗: Day 1 to Day 169
An adverse event (AE) was any untoward medical occurrence attributed to study drug in a participant who received study drug. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between administration of study drug and Day 169 that were absent before treatment or that worsened relative to pretreatment state.
次要结局
- Number of Participants With Anti-Drug Antibodies to MEDI-570 at Any Visit(Predose on Day 1; Day 85, 113, and 169)
- Pharmacokinetic Parameters for MEDI-570(Predose and postdose on Day 1; Day 3, 5, 8, 15, 29, 57, 85, 113, 141, and 169)