NCT07158437招募中1 期
A Randomized, Double-Blind, Placebo-Controlled Single-Ascending Dose and Multiple-Ascending Dose Phase 1 Study of SL-325 in Healthy Volunteers
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Safety and Tolerability
研究概览
简要总结
This first-in-human study is a randomized, double-blind, placebo-controlled, single-ascending dose and multiple-ascending dose study of SL-325 in healthy volunteers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Provide signed informed consent
- •18-55 years of age, inclusive, at the time of signing the informed consent form
- •Body mass index of 18-32 kg/m2, inclusive, and a total body weight > 50 kg
- •Laboratory values within normal limits or any abnormalities deemed not clinically significant by the Investigator
- •Participant agrees to practice birth control measures
排除标准
- •History or presence of a clinically significant infectious disease or hepatic, renal, gastrointestinal, cardiovascular, endocrine, respiratory, immunologic, hematologic, dermatologic, neurologic, or psychiatric abnormality
- •Any clinically significant abnormality on vital signs, electrocardiogram (ECG), or laboratory parameters
- •History of regular alcohol consumption within 6 months of Screening
- •Positive test for use of drugs or alcohol at Screening
- •History of use of tobacco- or nicotine-containing products within 3 months of Screening
- •History of infusion-related reaction or allergic reaction upon receipt of an IV infusion
- •Positive hepatitis B virus, hepatitis C virus, or human immunodeficiency virus (HIV) test at Screening
- •Blood donation within 90 days prior to Day -1 or plasma donation within 1 week prior to Day 1
- •Receipt of specific medications within a specified time period
- •Women who are currently breastfeeding or have a positive pregnancy test
研究组 & 干预措施
SAD: SL-325
Experimental
Participants will receive a single dose of SL-325 in escalating dose cohorts
干预措施: SL-325 (Biological)
SAD: Placebo
Placebo Comparator
Participants will receive a single dose of placebo (normal saline)
干预措施: Placebo (Normal Saline) (Other)
MAD: SL-325
Experimental
Participants will receive a three doses of SL-325 in escalating dose cohorts
干预措施: SL-325 (Biological)
MAD: Placebo
Placebo Comparator
Participants will receive a three doses of placebo (normal saline)
干预措施: Placebo (Normal Saline) (Other)
结局指标
主要结局
Safety and Tolerability
时间窗: Day 1 through 75 days after last dose
Incidence and severity of treatment-emergent adverse events
次要结局
- Pharmacokinetics (PK): Cmax(Day 1 through 75 days after last dose)
- Pharmacokinetics (PK): Tmax(Day 1 through 75 days after last dose)
- Pharmacokinetics (PK): Ctrough(Day 1 through 75 days after last dose)
- Pharmacokinetics (PK): AUC(Day 1 through 75 days after last dose)
- Pharmacokinetics (PK): T1/2(Day 1 through 75 days after last dose)
- Pharmacokinetics (PK): CL(Day 1 through 75 days after last dose)
- Pharmacokinetics (PK): Vz(Day 1 through 75 days after last dose)
- Immunogenicity: Number/proportion of participants with positive or negative anti-drug antibody (ADA) titers(Day 1 through 75 days after last dose)
- Immunogenicity: Number/proportion of participants with neutralizing anti-drug antibodies(Day 1 through 75 days after last dose)
- Immunogenicity: Time to onset and duration of anti-drug antibodies(Day 1 through 75 days after last dose)
- Immunogenicity: Number/proportion of participants with transient vs persistent anti-drug antibodies(Day 1 through 75 days after last dose)
- Receptor Occupancy: Percent of DR3-positive T cells bound by SL-325(Day 1 through 75 days after last dose)
- Receptor Occupancy: Duration of DR3-positive T cell binding by SL-325(Day 1 through 75 days after last dose)
研究者
研究点 (1)
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