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임상시험 NCT07405177은(는) 건강한에 대해 모집중 상태입니다. 모든 세부 정보를 보려면 임상시험 레이더 카드 뷰와 AI 발견 도구를 확인하거나 여기에서 무엇이든 물어보세요.
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A Study of MK-7240 in Healthy Participants (MK-7240-009) 1상 330

모집중
임상시험 세부 정보는 주로 영어로 제공됩니다. 하지만 임상 레이더 AI가 도와드릴 수 있습니다! '임상시험 설명'를 클릭하여 선택한 언어로 임상시험 정보를 확인하고, 이에 대해 AI와 논의해 보세요.
임상시험 NCT07405177은(는) 기초과학을(를) 알아보기 위한 연구입니다. 이 연구는 건강한에 대해 진행되며, 1상 중재연구으로 현재 상태는 모집중입니다. 연구는 2026년 3월 5일에 시작되어 330명의 참여자를 모집하고 있습니다. 머크이(가) 진행하며, 2026년 9월 3일까지 완료될 예정입니다. ClinicalTrials.gov의 가장 최근 정보는 2026년 3월 20일에 갱신되었습니다.
간단한 개요
The goal of this study is to learn what happens to MK-7240 in a healthy person's body over time (pharmacokinetic or PK study). Researchers also want to learn about the safety of MK-7240 and if people tolerate it.
공식 제목

A Randomized, Open-label, Parallel-group Study to Assess the Pharmacokinetic Bioequivalence of Subcutaneously-administered Tulisokibart Delivered by 2 Different Autoinjectors in Healthy Participants

질환명
건강한
기타 연구 식별자
  • 7240-009
  • MK-7240-009 (기타 식별자) (MSD)
NCT 번호
NCT07405177
실제 연구 시작일
2026-03-05
최신 업데이트 게시
2026-03-20
예상 연구 완료일
2026-09-03
계획된 등록 인원
330
연구종류
중재연구
단계/상
1상
상태
모집중
주요 목적
기초과학
설계 할당
무작위배정
중재 모델
평행설계
맹검 (마스킹)
없음 (오픈 라벨)
시험군 / 개입
참가자 그룹/시험군개입/치료
실험적Arm 1: Tulisokibart Form 1
Participants will receive tulisokibart form 1.
Tulisokibart Form 1
Solution for injection.
실험적Arm 2: Tulisokibart Form 2
Participants will receive tulisokibart form 2.
Tulisokibart Form 2
Solution for injection.
주요결과변수
결과변수측정값 설명시간 범위
Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-Inf) of Tulisokibart
Blood samples will be collected to determine the AUC0-inf of tulisokibart.
At designated timepoints up to 14 weeks
Area Under the Concentration-Time Curve from Time 0 to Last (AUC0-Last) of Tulisokibart
Blood samples will be collected to determine the AUC0-last of tulisokibart.
At designated timepoints up to 14 weeks
Maximum Plasma Concentration (Cmax) of Tulisokibart
Blood samples will be collected to determine the Cmax of tulisokibart.
At designated timepoints up to 14 weeks
이차결과변수
결과변수측정값 설명시간 범위
Number of Participants Who Experience an Adverse Event (AE)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
At designated timepoints up to 14 weeks
Number of Participants Who Discontinue Study Due to an AE
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
At designated timepoints up to 14 weeks
Time to Maximum Plasma Concentration (Tmax) of Tulisokibart
Blood samples will be collected to determine the Tmax of tulisokibart.
At designated timepoints up to 14 weeks
Apparent Clearance (CL/F) of Tulisokibart
Blood samples will be collected to determine the CL/F of tulisokibart.
At designated timepoints up to 14 weeks
Apparent Volume of Distribution (V/F) of Tulisokibart
Blood samples will be collected to determine the V/F of tulisokibart.
At designated timepoints up to 14 weeks
Apparent Terminal Half-life (t1/2) of Tulisokibart
Blood samples will be collected to determine the t1/2 of tulisokibart.
At designated timepoints up to 14 weeks
Apparent Terminal Elimination Rate constant (Kel) of Tulisokibart
Blood samples will be collected to determine the Kel of tulisokibart.
At designated timepoints up to 14 weeks
Ratio of AUC0-Last/AUC0-Inf of Tulisokibart
Blood samples will be collected to determine the ratio of AUC0-last/AUC0-inf of tulisokibart.
At designated timepoints up to 14 weeks
Area Under the Concentration-Time Curve from Time 0 to Day 14 (pAUC0-14) of Tulisokibart
Blood samples will be collected to determine pAUC0-14 of tulisokibart.
At designated timepoints up to 14 days
참여 도우미
적격성 기준

연령대
성인
최소 연령
18 Years
참여 가능한 성별
전체
건강한 참가자 허용
네

The main inclusion criteria include but are not limited to the following:

  • Has a body-mass index (BMI) between 18 and 32 kg/m^2

The main exclusion criteria include but are not limited to the following:

  • Has a history of more than 1 episode of herpes zoster infection or history of disseminated herpes zoster infection
  • Has a history of or current active tuberculosis (TB) infection or history of latent TB that was not fully treated
Merck Sharp & Dohme LLC logo머크
연구 대표 연락처
연락처: Toll Free Number, 1-888-577-8839, [email protected]
2 1개국에 임상시험 장소

Queensland

Nucleus Network ( Site 0002), Brisbane, Queensland, 4006, Australia
Study Coordinator, 연락처, +61737072720
모집중

Victoria

Nucleus Network ( Site 0001), Melbourne, Victoria, 3004, Australia
Study Coordinator, 연락처, +6138593 9801
모집중