A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of mRNA-6231 in Healthy Adults
A Phase 1, Dose-Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of mRNA-6231, Encoding for a Human Serum Albumin - Interleukin-2 Mutein Fusion Protein (HSA-IL2m), in Healthy Adults
연구 개요
연구 유형
등록 (실제)
단계
- 1단계
연락처 및 위치
연구 장소
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Victoria
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Melbourne, Victoria, 호주, 3004
- Nucleus Network Limited
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Key Inclusion Criteria:
- Understand and agree to comply with the study procedures and provide written informed consent
Key Exclusion Criteria:
- Has received any investigational product (for example, study drug, biologic, device) within 30 days or 5 elimination half-lives, whichever is longer
- Pregnant or lactating women
- Men and women of childbearing potential without effective contraception during the study
- Has any lab abnormalities or clinically significant medical condition that could interfere with the interpretation of study results or limit the participant's enrollment
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위화되지 않음
- 중재 모델: 순차적 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: mRNA-6231 Dose Level 1
In the single dose part of the study (Sentinel and Expansion Cohorts), each participant will receive 1 dose of Dose Level 1 of mRNA-6231 by subcutaneous injection on Day 1. In the repeat dose part of the study (Sentinel and Expansion Cohorts), each participant will receive up to 3 doses of Dose Level 1 of mRNA-6231 once every 2 weeks. |
Sterile frozen liquid dispersion for injection
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실험적: mRNA-6231 Dose Level 2
In the single dose part of the study (Sentinel and Expansion Cohorts), each participant will receive 1 dose of Dose Level 2 of mRNA-6231 by subcutaneous injection on Day 1. In the repeat dose part of the study (Sentinel and Expansion Cohorts), each participant will receive up to 3 doses of Dose Level 2 of mRNA-6231 once every 2 weeks. |
Sterile frozen liquid dispersion for injection
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실험적: mRNA-6231 Dose Level 3
In the single dose part of the study (Sentinel and Expansion Cohorts), each participant will receive 1 dose of Dose Level 3 of mRNA-6231 by subcutaneous injection on Day 1. In the repeat dose part of the study (Sentinel and Expansion Cohorts), each participant will receive up to 3 doses of Dose Level 3 of mRNA-6231 once every 2 weeks. |
Sterile frozen liquid dispersion for injection
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
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Number of Participants with Adverse Events (AEs) and Serious AEs
기간: Up to Day 84
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Up to Day 84
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2차 결과 측정
결과 측정 |
기간 |
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Maximum Observed Concentration (Cmax) of mRNA (Serum) and SM-86 (Plasma)
기간: Predose (1 hour prior to study drug administration) to 8 hours postdose on Day 1 to Day 29
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Predose (1 hour prior to study drug administration) to 8 hours postdose on Day 1 to Day 29
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Area Under the Concentration-Time Curve (AUC) of mRNA (Serum) and SM-86 (Plasma)
기간: Predose (1 hour prior to study drug administration) to 8 hours postdose on Day 1 to Day 29
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Predose (1 hour prior to study drug administration) to 8 hours postdose on Day 1 to Day 29
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Time to Maximum to Observed Effect (TEmax) of mRNA-6231
기간: Predose (1 hour prior to study drug administration) to 8 hours postdose on Day 1 to Day 29
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Predose (1 hour prior to study drug administration) to 8 hours postdose on Day 1 to Day 29
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Maximum Observed Effect (Emax) of mRNA-6231
기간: Predose (1 hour prior to study drug administration) to 8 hours postdose on Day 1 to Day 29
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Predose (1 hour prior to study drug administration) to 8 hours postdose on Day 1 to Day 29
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Area Under the Effect Versus Time Curve (AUEClast) of mRNA-6231
기간: Predose (1 hour prior to study drug administration) to 8 hours postdose on Day 1 to Day 29
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Predose (1 hour prior to study drug administration) to 8 hours postdose on Day 1 to Day 29
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공동 작업자 및 조사자
스폰서
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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. .
mRNA-6231에 대한 임상 시험
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Judit Pich Martínez완전한
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ModernaTX, Inc.완전한인플루엔자 | 사스 코로나바이러스 2 | RSV영국, 호주, 미국
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ModernaTX, Inc.모집하지 않고 적극적으로
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ModernaTX, Inc.완전한
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ModernaTX, Inc.모집하지 않고 적극적으로
-
ModernaTX, Inc.완전한
-
ModernaTX, Inc.모집하지 않고 적극적으로