Relative Bioavailability, Safety, and Tolerability of Single-dose Sotrovimab Injection in Adults (COSMIC) (COSMIC)
2022年11月2日 更新者：Vir Biotechnology, Inc.
A Phase 1, Open-label, Randomized, Parallel Group, Single-dose Clinical Pharmacology Study to Investigate the Relative Bioavailability, Safety, and Tolerability of Two Different Concentrations of Sotrovimab Administered at Different Injection Sites, in Male or Female Healthy Participants Aged 18 to 65 Years
This clinical pharmacology study will evaluate the relative bioavailability, safety, and tolerability of two different concentrations of sotrovimab injections administered at different injection sites in male or female healthy participants aged 18 to 65 years.
The study will be conducted in three parts (Part A, an optional Part B and Part C).
研究概览
研究类型
介入性
注册 (预期的)
504
阶段
- 阶段1
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Study Inquiry
- 电话号码：4156545281
- 邮箱：clinicaltrials@vir.bio
学习地点
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California
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Riverside、California、美国、92503
- 招聘中
- Investigative Site
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Florida
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Atlantis、Florida、美国、33462
- 招聘中
- Investigative Site
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Edgewater、Florida、美国、32132
- 招聘中
- Investigative Site
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接触：
- Study Inquiry
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Missouri
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Saint Louis、Missouri、美国、63141
- 招聘中
- Investigative Site
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New York
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Binghamton、New York、美国、13901
- 招聘中
- Investigative Site
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Oklahoma
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Yukon、Oklahoma、美国、73099
- 招聘中
- Investigative Site
-
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Oregon
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Medford、Oregon、美国、97504
- 招聘中
- Investigative Site
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接触：
- Study Inquiry
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Texas
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Austin、Texas、美国、78745
- 招聘中
- Investigative Site
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Houston、Texas、美国、77065
- 招聘中
- Investigative Site
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Utah
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West Jordan、Utah、美国、84088
- 招聘中
- Investigative Site
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 65年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Male or female participants, aged 18 to 65 years, inclusive.
- Participants who are healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring.
- For Part C, inclusion in the Japanese subgroup analysis, a participant must meet all of the following criteria: Japanese ancestry, defined as being a descendant of 4 ethnic Japanese grandparents and 2 ethnic Japanese parents.
- Body Mass Index (BMI) within the range of 18 to 30 kilogram per square meter (kg/m^2).
- Capable of giving signed informed consent
Exclusion Criteria:
- History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs
- Lymphoma, leukemia, or any malignancy 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
- Breast cancer within the past 10 years
- Abnormal blood pressure at Screening.
- Known hypersensitivity to any constituent present in the investigational product or history of severe hypersensitivity or anaphylaxis after receiving a COVID-19 vaccine
- Clinically significant multiple or severe drug allergies, intolerance to topical corticosteroids, or severe post-treatment hypersensitivity reactions
- Current or chronic history of liver disease or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
- Use of any over the counter or prescription medications unless permitted by the protocol or approved by the Investigator in conjunction with the GSK medical monitor.
- For Part A and Part B, any condition that would prohibit receipt of injections in the investigator's opinion, such as coagulation disorder, bleeding diathesis, or thrombocytopenia.
- Treatment with biologic agents (such as) within 3 months or 5 half-lives
- Receipt of convalescent plasma from a recovered COVID-19 participant or anti- severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) monoclonal antibody (mAb) within the last 3 months.
- Receipt of any vaccine within 48 hours prior to enrollment.
- Has received a SARS-CoV-2 vaccine but has not completed all doses in the series more than 28 days prior to Screening.
- Exposure to more than 4 new chemical entities (e.g., investigational pharmaceuticals) within 12 months prior to the first dosing day.
- Enrolment in any investigational vaccine study within the last 180 days or enrollment in any other investigational drug study within 30 days prior to Day 1 or within 5 half-lives
- Current enrolment or past participation in this clinical study.
- A positive pre-study hepatitis B surface antigen or positive hepatitis C antibody test result at Screening or within 3 months prior to dosing.
- Positive pre-study drug/alcohol screen.
- Positive human immunodeficiency virus (HIV) antibody test.
- History of regular alcohol consumption within 6 months prior to the study.
- Regular use of known drugs of abuse.
- Sensitivity to any of the study interventions, or components thereof, or drug or other allergy that, in the opinion of the investigator or medical monitor, contraindicates participation in the study.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Part A Cohort 1: Concentration 1 of sotrovimab
administered at injection site 1
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via IM injection
via IV infusion
|
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实验性的：Part A Cohort 2: Concentration 2 of sotrovimab
administered at injection site 1
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via IM injection
via IV infusion
|
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实验性的：Part A Cohort 3: Concentration 2 of sotrovimab
administered at injection site 2
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via IM injection
via IV infusion
|
|
实验性的：Part A Cohort 4: Concentration 2 of sotrovimab
administered at injection site 3
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via IM injection
via IV infusion
|
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实验性的：Part B Cohort 5: Concentration 1 of sotrovimab
administered at potential injection site 1,2,3 or other
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via IM injection
via IV infusion
|
|
实验性的：Part B Cohort 6: Concentration 2 of sotrovimab
administered at potential injection site 1,2,3 or other
|
via IM injection
via IV infusion
|
|
实验性的：Part C Cohort 7: Concentration 2 of sotrovimab
administered by intravenous (IV) infusion
|
via IM injection
via IV infusion
|
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实验性的：Part C Cohort 8: Concentration 2 of sotrovimab
administered by IV infusion
|
via IM injection
via IV infusion
|
研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
Part A (Cohort 1, 2): Area under the serum concentration-time curve (AUC) from Day 1 to Day 29 (AUC D1-29) following administration of sotrovimab
大体时间：Up to Day 29
|
Up to Day 29
|
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Part A (Cohort 1, 2): Maximum observed concentration (Cmax) following administration of sotrovimab through Day 29
大体时间：Up to Day 29
|
Up to Day 29
|
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Part A (Cohort 1, 2): Number of participants with adverse events (AEs), serious adverse events (SAEs), and AEs of special interest (AESI) through Day 29
大体时间：Up to Day 29
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Up to Day 29
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Part C (Cohort 7, 8): Number of participants with AEs, SAEs, and AESI
大体时间：Up to Day 29
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Up to Day 29
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次要结果测量
结果测量 |
大体时间 |
|---|---|
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Part A (Cohort 1, 3, 4): AUC(D1-29) following administration of sotrovimab
大体时间：Up to Day 29
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Up to Day 29
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Part A (Cohort 1, 3, 4): Cmax following administration of sotrovimab through Day 29
大体时间：Up to Day 29
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Up to Day 29
|
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Part A (Cohort 1, 2, 3, 4): Area under the serum concentration-time curve from time zero to infinity (AUCinf) following administration of sotrovimab at injection sites 1, 2 and 3 through Week 24
大体时间：Up to Week 24
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Up to Week 24
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Part A: Serum concentration following administration of sotrovimab through Day 29
大体时间：Up to Day 29
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Up to Day 29
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Part A: Serum concentration following administration of sotrovimab through Week 24
大体时间：Up to Week 24
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Up to Week 24
|
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Part A (Cohort 3, 4) and Part B: Number of participants with AEs, SAEs, and AESI
大体时间：Up to Day 29
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Up to Day 29
|
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Part A and Part B: Number of participants with AEs, SAEs, and AESI
大体时间：Up to Week 35
|
Up to Week 35
|
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Part B: AUC(D1-29) following administration of sotrovimab
大体时间：Up to Day 29
|
Up to Day 29
|
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Part B: Cmax following administration of sotrovimab through Day 29
大体时间：Up to Day 29
|
Up to Day 29
|
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Part B: AUCinf following administration of sotrovimab at up to 2 injection sites through Week 24
大体时间：Up to Week 24
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Up to Week 24
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Part B: Serum concentration following administration of sotrovimab through Day 29
大体时间：Up to Day 29
|
Up to Day 29
|
|
Part B: Serum concentration following administration of sotrovimab through Week 24
大体时间：Up to Week 24
|
Up to Week 24
|
|
Part C: AUC(D1-29) following administration of sotrovimab
大体时间：Up to Day 29
|
Up to Day 29
|
|
Part C: Cmax following administration of sotrovimab through Day 29
大体时间：Up to Day 29
|
Up to Day 29
|
|
Part C: Serum concentration following administration of sotrovimab through Day 29
大体时间：Up to Day 29
|
Up to Day 29
|
|
Part C: Serum concentration following administration of sotrovimab through Week 24
大体时间：Up to Week 24
|
Up to Week 24
|
|
Part C: Number of participants with AEs, SAEs, and AESI
大体时间：Up to Week 35
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Up to Week 35
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2022年3月28日
初级完成 (预期的)
2024年3月4日
研究完成 (预期的)
2024年5月30日
研究注册日期
首次提交
2022年3月4日
首先提交符合 QC 标准的
2022年3月4日
首次发布 (实际的)
2022年3月15日
研究记录更新
最后更新发布 (实际的)
2022年11月8日
上次提交的符合 QC 标准的更新
2022年11月2日
最后验证
2022年11月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.