NCT03695198已完成1 期
A Single Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of LY3361237 in Healthy Subjects
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
研究概览
简要总结
The purposes of this study are to determine:
- The safety of LY3361237 and any side effects that might be associated with it.
- How much LY3361237 gets into the blood stream and how long it takes the body to remove it in healthy participants.
Participants will be admitted to the clinical research unit (CRU) for 4 overnight stays. The study will last about 12 weeks for each participant, not including screening.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
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
- •Healthy males or females, as determined by medical history and physical examination.
- •To qualify as Japanese for this study, the participant, the participant's biological parents, and all of the participant's biological grandparents must be of exclusive Japanese descent and born in Japan.
- •Between 18 (20 for Japanese participants) and 65 years of age.
- •Have a body mass index of 18.0 to 32.0 kilograms per meter squared, inclusive, and a minimum body weight of 45.0 kilograms.
排除标准
- •Show evidence of active or latent tuberculosis (TB), as documented by medical history and examination, chest x-ray and TB testing
- •Are immunocompromised
- •Have evidence of chronic viral infection have received live vaccine(s) (including attenuated live vaccines) within 28 days of screening or intend to receive during the study (non-live or inactivated vaccinations are allowed). Bacillus Calmette-Guérin (BCG) vaccine must not have been administered within 12 months of screening
- •Have had lymphoma, leukemia, or any malignancy or pre-malignant condition within the past 5 years except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years
研究组 & 干预措施
LY3361237 - Subcutaneous (SC)
Experimental
LY3361237 administered SC
干预措施: LY3361237 - SC (Drug)
Placebo - SC
Placebo Comparator
Placebo administered SC
干预措施: Placebo - SC (Drug)
LY3361237 - Intravenous (IV)
Experimental
LY3361237 administered IV
干预措施: LY3361237 - IV (Drug)
Placebo - IV
Placebo Comparator
Placebo administered IV
干预措施: Placebo - IV (Drug)
结局指标
主要结局
Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
时间窗: Baseline through Week 12
A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module
次要结局
- Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3361237(Predose through Week 12)
- PK: Area Under the Plasma Concentration Time Curve (AUC) of LY3361237(Predose through Week 12)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
1 期
A Study of LY3200327 in Healthy ParticipantsHealthyNCT02595736Eli Lilly and Company52
终止
1 期
A Study of LY3478006 in Healthy ParticipantsHealthyNCT04230122Eli Lilly and Company4
已完成
1 期
A Study of LY3323795 in Healthy ParticipantsHealthyNCT02989389Eli Lilly and Company42
已完成
1 期
A Study of LY3039478 in Healthy ParticipantsHealthyNCT02659865Eli Lilly and Company29
已完成
1 期
A Study of LY3461767 in Healthy ParticipantsHealthyNCT04352114Eli Lilly and Company48