Relative Bioavailability, Safety, and Tolerability of Single-dose Sotrovimab Injection in Adults (COSMIC) (COSMIC)
2022년 11월 2일 업데이트: 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).
연구 개요
연구 유형
중재적
등록 (예상)
504
단계
- 1단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Study Inquiry
- 전화번호: 4156545281
- 이메일: clinicaltrials@vir.bio
연구 장소
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California
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Riverside, California, 미국, 92503
- 모병
- Investigative Site
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Florida
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Atlantis, Florida, 미국, 33462
- 모병
- Investigative Site
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Edgewater, Florida, 미국, 32132
- 모병
- Investigative Site
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연락하다:
- Study Inquiry
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Missouri
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Saint Louis, Missouri, 미국, 63141
- 모병
- Investigative Site
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New York
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Binghamton, New York, 미국, 13901
- 모병
- Investigative Site
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Oklahoma
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Yukon, Oklahoma, 미국, 73099
- 모병
- Investigative Site
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Oregon
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Medford, Oregon, 미국, 97504
- 모병
- Investigative Site
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연락하다:
- Study Inquiry
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Texas
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Austin, Texas, 미국, 78745
- 모병
- Investigative Site
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Houston, Texas, 미국, 77065
- 모병
- Investigative Site
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Utah
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West Jordan, Utah, 미국, 84088
- 모병
- Investigative Site
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
18년 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
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.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: 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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실험적: 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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실험적: Part A Cohort 3: Concentration 2 of sotrovimab
administered at injection site 2
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via IM injection
via IV infusion
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실험적: 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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실험적: 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
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실험적: Part B Cohort 6: Concentration 2 of sotrovimab
administered at potential injection site 1,2,3 or other
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via IM injection
via IV infusion
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실험적: Part C Cohort 7: Concentration 2 of sotrovimab
administered by intravenous (IV) infusion
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via IM injection
via IV infusion
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실험적: Part C Cohort 8: Concentration 2 of sotrovimab
administered by IV infusion
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via IM injection
via IV infusion
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
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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
기간: Up to Day 29
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Up to Day 29
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Part A (Cohort 1, 2): Maximum observed concentration (Cmax) following administration of sotrovimab through Day 29
기간: Up to Day 29
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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
기간: 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
기간: Up to Day 29
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Up to Day 29
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2차 결과 측정
결과 측정 |
기간 |
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Part A (Cohort 1, 3, 4): AUC(D1-29) following administration of sotrovimab
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: Up to Week 35
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Up to Week 35
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Part B: AUC(D1-29) following administration of sotrovimab
기간: Up to Day 29
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Up to Day 29
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Part B: Cmax following administration of sotrovimab through Day 29
기간: Up to Day 29
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Up to Day 29
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Part B: AUCinf following administration of sotrovimab at up to 2 injection sites through Week 24
기간: 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
기간: Up to Day 29
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Up to Day 29
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Part B: Serum concentration following administration of sotrovimab through Week 24
기간: Up to Week 24
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Up to Week 24
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Part C: AUC(D1-29) following administration of sotrovimab
기간: Up to Day 29
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Up to Day 29
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Part C: Cmax following administration of sotrovimab through Day 29
기간: Up to Day 29
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Up to Day 29
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Part C: Serum concentration following administration of sotrovimab through Day 29
기간: Up to Day 29
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Up to Day 29
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Part C: Serum concentration following administration of sotrovimab through Week 24
기간: Up to Week 24
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Up to Week 24
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Part C: Number of participants with AEs, SAEs, and AESI
기간: Up to Week 35
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Up to Week 35
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2022년 3월 28일
기본 완료 (예상)
2024년 3월 4일
연구 완료 (예상)
2024년 5월 30일
연구 등록 날짜
최초 제출
2022년 3월 4일
QC 기준을 충족하는 최초 제출
2022년 3월 4일
처음 게시됨 (실제)
2022년 3월 15일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2022년 11월 8일
QC 기준을 충족하는 마지막 업데이트 제출
2022년 11월 2일
마지막으로 확인됨
2022년 11월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- VIR-7831-5012
- GSK Study 218128 (기타 식별자: GlaxoSmithKline)
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
예
미국 FDA 규제 기기 제품 연구
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .