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임상시험 NCT07133828은(는) 건강 자원봉사자에 대해 모집중 상태입니다. 모든 세부 정보를 보려면 임상시험 레이더 카드 뷰와 AI 발견 도구를 확인하거나 여기에서 무엇이든 물어보세요. | ||
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바이오젠A Study to Learn About the Safety of BIIB142 and How it is Processed in the Body of Healthy Adult Participants Aged 18 to 55 Years Old 1상 78 용량 증량 단일 투여
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 NCT07133828은(는) 치료을(를) 알아보기 위한 연구입니다. 이 연구는 건강 자원봉사자에 대해 진행되며, 1상 중재연구으로 현재 상태는 모집중입니다. 연구는 2025년 8월 29일에 시작되어 78명의 참여자를 모집하고 있습니다. 바이오젠이(가) 진행하며, 2026년 8월 6일까지 완료될 예정입니다. ClinicalTrials.gov의 가장 최근 정보는 2025년 9월 11일에 갱신되었습니다.
간단한 개요
In this study, researchers will learn more about the safety of BIIB142 and how it is processed in the body. This is the first time that researchers will learn about BIIB142 and how it affects people.
The main question researchers want to answer in this study is:
• How many participants have adverse events (AEs) and serious adverse events (SAEs)?
An AE is a health problem that may or may not be caused by a drug dur...
더 보기상세한 설명
The primary objective of this study is to evaluate the safety and tolerability of single and multiple ascending oral doses of BIIB142 in healthy adult participants.
The secondary objective of this study is to evaluate the pharmacokinetics (PK) profile of single and multiple ascending oral doses of BIIB142 in healthy adult participants.
공식 제목
A Phase 1, Randomized, Blinded, Placebo-Controlled, Single- and Multiple-Ascending Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BIIB142 in Healthy Adults
질환명
건강 자원봉사자기타 연구 식별자
- 300HV101
NCT 번호
실제 연구 시작일
2025-08-29
최신 업데이트 게시
2025-09-11
예상 연구 완료일
2026-08-06
계획된 등록 인원
78
연구종류
중재연구
단계/상
1상
상태
모집중
주요 목적
치료
설계 할당
무작위배정
중재 모델
평행설계
맹검 (마스킹)
이중맹검
시험군 / 개입
| 참가자 그룹/시험군 | 개입/치료 |
|---|---|
실험적Part A [Single Ascending Dose (SAD)]: BIIB142Cohort 1A Participants will receive Dose A of BIIB142 or a matching placebo on Day 1 in a fasted state. | BIIB142 Administered Orally BIIB142-Matching Placebo Administered Orally |
실험적Part A (SAD): BIIB142 Cohort 2A Participants will receive Dose B of BIIB142 or a matching placebo on Day 1 in a fasted state. | BIIB142 Administered Orally BIIB142-Matching Placebo Administered Orally |
실험적Part A (SAD): BIIB142 Cohort 3A Participants will receive Dose C of BIIB142 or a matching placebo on Day 1 in a fasted state. | BIIB142 Administered Orally BIIB142-Matching Placebo Administered Orally |
실험적Part A (SAD): BIIB142 Cohort 4A Participants will receive Dose D of BIIB142 or a matching placebo on Day 1 in a fasted state. | BIIB142 Administered Orally BIIB142-Matching Placebo Administered Orally |
실험적Part A (SAD): BIIB142 Cohort 5A Participants will receive Dose E of BIIB142 or a matching placebo on Day 1 in a fasted state. | BIIB142 Administered Orally BIIB142-Matching Placebo Administered Orally |
실험적Part A (SAD): BIIB142 Cohort 6A Participants will receive BIIB142 on Day 1 in the fasted followed by fed state in the first sequence, and vice versa in the second sequence. A washout period of 14 days will be maintained between both the sequences. Dose will be determined based on emerging PK data. | BIIB142 Administered Orally |
실험적Part B [Multiple Ascending Dose (MAD)]: BIIB142 Cohort 1B Participants will receive Dose A of BIIB142 or a matching placebo administered orally once daily for 14 days in a fasted state. | BIIB142 Administered Orally BIIB142-Matching Placebo Administered Orally |
실험적Part B (MAD): BIIB142 Cohort 2B Participants will receive Dose F of BIIB142 or a matching placebo administered orally once daily for 14 days in a fasted state. | BIIB142 Administered Orally BIIB142-Matching Placebo Administered Orally |
실험적Part B (MAD): BIIB142 Cohort 3B Participants will receive Dose D of BIIB142 or a matching placebo administered orally once daily for 14 days in a fasted state. | BIIB142 Administered Orally BIIB142-Matching Placebo Administered Orally |
주요결과변수
이차결과변수
| 결과변수 | 측정값 설명 | 시간 범위 |
|---|---|---|
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | Part A (SAD): Up to Day 15; Part B (MAD): Up to Day 29 | |
Number of Participants with Clinical Laboratory Abnormalities | Part A (SAD): Up to Day 15; Part B (MAD): Up to Day 29 | |
Number of Participants with Potentially Clinically Relevant Abnormalities in Vital Sign Parameters | Part A (SAD): Up to Day 15; Part B (MAD): Up to Day 29 | |
Number of Participants With Change From Baseline in Columbia Suicide Severity Rating Scale (C-SSRS) Score | Part B (MAD): Up to Day 29 | |
Number of Participants With Potentially Clinically Relevant Abnormalities in 12-lead Electrocardiogram (ECG) Parameters | Part A (SAD): Up to Day 15; Part B (MAD): Up to Day 29 |
| 결과변수 | 측정값 설명 | 시간 범위 |
|---|---|---|
Plasma Concentration of BIIB142 | Pre-dose and at multiple timepoints post-dose [Part A (SAD): Up to Day 15; Part B (MAD): Up to Day 29] | |
Area Under the Concentration-Time Curve (AUC) of BIIB142 | Pre-dose and at multiple timepoints post-dose [Part A (SAD): Up to Day 15; Part B (MAD): Up to Day 29] | |
Maximum Observed Concentration (Cmax) of BIIB142 | Pre-dose and at multiple timepoints post-dose [Part A (SAD): Up to Day 15; Part B (MAD): Up to Day 29] | |
Time to Maximum Observed Concentration (Tmax) of BIIB142 | Pre-dose and at multiple timepoints post-dose [Part A (SAD): Up to Day 15; Part B (MAD): Up to Day 29] | |
Apparent Clearance (CL/F) of BIIB142 | Pre-dose and at multiple timepoints post-dose [Part A (SAD): Up to Day 15; Part B (MAD): Up to Day 29] | |
Apparent Volume of Distribution (Vz/F) of BIIB142 | Pre-dose and at multiple timepoints post-dose [Part A (SAD): Up to Day 15; Part B (MAD): Up to Day 29] | |
Elimination Half-Life (t1/2) of BIIB142 | Pre-dose and at multiple timepoints post-dose [Part A (SAD): Up to Day 15; Part B (MAD): Up to Day 29] |
참여 도우미
적격성 기준
연령대
성인
최소 연령
18 Years
참여 가능한 성별
전체
건강한 참가자 허용
네
- Have a body mass index between 18 and 32 kilograms per square meter (kg/m^2), inclusive, at screening.
- Weight ≥ 50 kilograms (kg) at screening.
- Negative polymerase chain reaction (PCR) test for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) at Check-in prior to randomization.
- Must be in good health as determined by the Investigator.
- History of any clinically significant cardiac, endocrine, gastrointestinal, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, or renal disease, or other major disease, as determined by the Investigator.
- History of severe allergic or anaphylactic reactions
- History of or ongoing malignant disease (with limited exceptions)
- Systolic blood pressure >150 millimeters of mercury (mmHg) or <90 mmHg.
- Clinically significant (as determined by the Investigator) electrocardiogram (ECG) abnormalities.
- History of or positive test for human immunodeficiency virus (HIV).
- Chronic, recurrent, or serious infection within 90 days prior to Screening.
- Symptoms of bacterial, fungal, or viral infection within 14 days prior to Screening.
- Any live or attenuated immunization within 14 days prior to Screening.
- Use of prescription medications, over-the-counter medications that alter hepatic or renal clearance, or nutraceuticals within 28 days prior to Check-in.
- MAD Cohorts only: Suicidal ideation with some intent to act within 6 months prior to the start of Screening or history of suicidal behavior within one year prior to Screening.
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
바이오젠연구 대표 연락처
연락처: US Biogen Clinical Trial Center, 866-633-4636, [email protected]
연락처: Global Biogen Clinical Trial Center, [email protected]
1 1개국에 임상시험 장소
Nevada
PPD Development, LP, Las Vegas, Nevada, 89113, United States
연락처, 702-963-1600
Shawn Searle, 책임연구자
모집중