A Randomized, Placebo-Controlled Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single Ascending Doses of SBT115301 in Healthy Participants
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Serious adverse events
研究概览
简要总结
This study will test the safety and effects of SBT115301 when given as a single dose to healthy adult volunteers. It is the first study being done in humans. Increasing dose levels will be given after the safety at lower dose levels is shown. Some participants will receive placebo, and neither the participants or the study staff will know what drug (SBT115301 or placebo) is being given.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Males or females not of childbearing potential
- •Healthy participants based on medical history, physical examination, vital signs, electrocardiogram, and clinical laboratory tests
- •Use of highly effective methods of contraception (sexually active males with partners of childbearing potential)
- •Up-to-date vaccinations for coronavirus disease (COVID-19) and influenza
排除标准
- •Chronic or acute illness
- •History of drug or alcohol abuse or positive drug or alcohol screening results
- •Clinically significant ECG abnormality
- •Received attenuated live vaccine within 1 month or COVID-19 vaccine within 2 weeks prior to study, or anticipated vaccination during study period
研究组 & 干预措施
Cohort 3
IM dose level 3
干预措施: Placebo (Biological)
Cohort 4
IM dose level 4
干预措施: SBT115301 (Biological)
Cohort 1
Intramuscular (IM) dose level 1
干预措施: SBT115301 (Biological)
Cohort 1
Intramuscular (IM) dose level 1
干预措施: Placebo (Biological)
Cohort 2
IM dose level 2
干预措施: SBT115301 (Biological)
Cohort 2
IM dose level 2
干预措施: Placebo (Biological)
Cohort 3
IM dose level 3
干预措施: SBT115301 (Biological)
Cohort 4
IM dose level 4
干预措施: Placebo (Biological)
Cohort 5
Intravenous (IV) dose level 1
干预措施: SBT115301 (Biological)
Cohort 5
Intravenous (IV) dose level 1
干预措施: Placebo (Biological)
结局指标
主要结局
Serious adverse events
时间窗: Baseline to end of follow-up period (71 days for Cohorts 1-4; 140 days for Cohort 5)
Number of participants with serious adverse events
Adverse events
时间窗: Day of treatment to end of follow-up period (71 days for Cohorts 1-4; 140 days for Cohort 5)
Number of participants with treatment-emergent adverse events
次要结局
- Pharmacokinetic Parameters: Tmax(Day 1 to Day 72 (Cohorts 1-4) or Day 141 (Cohort 5))
- Pharmacokinetic Parameters: AUC(0-last)(Day 1 to Day 72 (Cohorts 1-4) or Day 141 (Cohort 5))
- Pharmacokinetic Parameters: t1/2(Day 1 to Day 72 (Cohorts 1-4) or Day 141 (Cohort 5))
- Anti-Drug Antibodies(Day 1 to Day 72 (Cohorts 1-4) or Day 141 (Cohort 5))
- SBT115301 Serum Concentration(Day 1 to Day 72 (Cohorts 1-4) or Day 141 (Cohort 5))
- Pharmacokinetic Parameters: Cmax(Day 1 to Day 72 (Cohorts 1-4) or Day 141 (Cohort 5))
- Pharmacokinetic Parameters: AUC(0-inf)(Day 1 to Day 72 (Cohorts 1-4) or Day 141 (Cohort 5))