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임상시험 NCT06673238은(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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애브비A Study to Assess How the Drug Moves Through the Body, Adverse Events, and Tolerability of Oral ABBV-722 Capsules of Single and Multiple Ascending Doses in Adult Participants and Single Doses in Adult Asian Participants 1상 96 최초 인체 적용 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 NCT06673238은(는) 치료을(를) 알아보기 위한 연구입니다. 이 연구는 건강 자원봉사자에 대해 진행되며, 1상 중재연구으로 현재 상태는 모집중입니다. 연구는 2024년 10월 29일에 시작되어 96명의 참여자를 모집하고 있습니다. 애브비이(가) 진행하며, 2026년 4월 1일까지 완료될 예정입니다. ClinicalTrials.gov의 가장 최근 정보는 2025년 7월 20일에 갱신되었습니다.
간단한 개요
This is a Phase 1, first-in-human study to investigate safety, tolerability, and pharmacokinetics of ABBV-722 after oral dosing in healthy adult participants.
공식 제목
A First-In-Human Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of ABBV-722 Following Single and Multiple Ascending Doses in Healthy Adult Subjects and Single Doses in Healthy Adult Asian Subjects
질환명
건강 자원봉사자기타 연구 식별자
- M25-150
NCT 번호
실제 연구 시작일
2024-10-29
최신 업데이트 게시
2025-07-20
예상 연구 완료일
2026-04
계획된 등록 인원
96
연구종류
중재연구
단계/상
1상
상태
모집중
키워드
Healthy Volunteer
ABBV-722
ABBV-722
주요 목적
치료
설계 할당
무작위배정
중재 모델
평행설계
맹검 (마스킹)
이중맹검
시험군 / 개입
| 참가자 그룹/시험군 | 개입/치료 |
|---|---|
실험적Part 1: Group 1 Participants will receive a single dose of either ABBV-722 Dose A or placebo. | ABBV-722 Oral Capsule 위약 Oral Capsule |
실험적Part 1: Group 2 Participants will receive a single dose of either ABBV-722 Dose B or placebo. | ABBV-722 Oral Capsule 위약 Oral Capsule |
실험적Part 1: Group 3 Participants will receive a single dose of either ABBV-722 Dose C or placebo. | ABBV-722 Oral Capsule 위약 Oral Capsule |
실험적Part 1: Group 4 Participants will receive a single dose of either ABBV-722 Dose TBD or placebo. | ABBV-722 Oral Capsule 위약 Oral Capsule |
실험적Part 1: Group 5 Participants will receive a single dose of either ABBV-722 Dose TBD or placebo. | ABBV-722 Oral Capsule 위약 Oral Capsule |
실험적Part 2: Group 6 Participants who are Han Chinese will receive a single dose of ABBV-722 Dose D. | ABBV-722 Oral Capsule |
실험적Part 2: Group 7 Participants who are Japanese will receive a single dose of ABBV-722 Dose D. | ABBV-722 Oral Capsule |
실험적Part 3: Group 8 Participants will receive either ABBV-722 Dose E or placebo for 14 days. | ABBV-722 Oral Capsule 위약 Oral Capsule |
실험적Part 3: Group 9 Participants will receive either ABBV-722 Dose F or placebo for 14 days. | ABBV-722 Oral Capsule 위약 Oral Capsule |
실험적Part 3: Group 10 Participants will receive either ABBV-722 Dose A or placebo for 14 days. | ABBV-722 Oral Capsule 위약 Oral Capsule |
실험적Part 3: Group 11 Participants will receive either ABBV-722 Dose G or placebo for 14 days. | ABBV-722 Oral Capsule 위약 Oral Capsule |
실험적Part 3: Group 12 Participants will receive either ABBV-722 Dose TBD or placebo for 14 days. | ABBV-722 Oral Capsule 위약 Oral Capsule |
주요결과변수
| 결과변수 | 측정값 설명 | 시간 범위 |
|---|---|---|
Number of Participants with Adverse Events Reported During Safety Evaluations | Safety evaluations will include AE monitoring, vital sign measurements (including orthostatic blood pressure and pulse rate), ECG variables, and clinical laboratory testing (hematology, chemistry, and urinalysis) as a measure of safety and tolerability for the entire study duration. Clinically significant abnormal changes in physical examination findings will be reported as AEs. | Up to Day 44 |
Maximum Plasma Concentration (Cmax) of ABBV-722 | Cmax of ABBV-722. | Up to Day 21 |
Time to Cmax (Tmax) of ABBV-722 | Tmax of ABBV-722. | Up to Day 21 |
For Parts 1 and 2: Area Under the Concentration-Time Curve (AUC) from Time 0 to Time t (AUCt) of ABBV-722 | AUCt of ABBV-722. | Up to Day 8 |
For Parts 1 and 2: Area Under the Concentration-Time Curve (AUC) from Time 0 to Infinity (AUCinf) of ABBV-722 | AUCinf of ABBV-722 | Up to Day 8 |
For Part 3: Observed Plasma Concentration at the End of the Dosing Interval (Ctrough) of ABBV-722 | Ctrough of ABBV-722. | Up to Day 21 |
For Part 3: AUC from Time 0 to the End of Dosing Interval (AUCtau) Following the First and Last Doses of ABBV-722 | AUC from AUCtau following the first and last doses of ABBV-722. | Up to Day 21 |
Terminal Phase Elimination Rate Constant (Beta) of ABBV-722 | Beta of ABBV-722. | Up to Day 21 |
Terminal Phase Elimination Half-Life (t1/2) of ABBV-722 | t1/2 of ABBV-722. | Up to Day 21 |
Dose Normalized Cmax | Dose normalized Cmax. | Up to Day 21 |
Dose Normalized AUCs | Dose normalized AUCs. | Up to Day 21 |
참여 도우미
적격성 기준
연령대
성인, 노인
최소 연령
18 Years
참여 가능한 성별
전체
건강한 참가자 허용
네
Laboratory values meet the criteria specified in the protocol.
A condition of general good health, based upon the results of a medical history, physical examination, vital signs, laboratory profile, and a 12-lead electrocardiogram (ECG).
Part 2 only: Healthy Han Chinese and Japanese individuals between 18 and 65 years of age, inclusive at the time of Screening.
- Participant must be first- or second-generation Han Chinese of full Chinese parentage (both parents of Han Chinese descent), residing outside of China. Participants must be in general good health and maintain a typical Chinese lifestyle, including consuming a typical Chinese diet.
- First-generation participants will have been born in China to two parents and four grandparents, who were also born in China, and are of full Chinese descent.
- Second-generation participants born outside of China must have two parents and four grandparents born in China and are of full Chinese descent. OR
- Participant must be first- or second-generation Japanese of full Japanese parentage (both parents of Japanese descent), residing outside of Japan. Participants must be in general good health and maintain a typical Japanese lifestyle, including consuming a typical Japanese diet.
- First-generation participants will have been born in Japan to two parents and four grandparents, who were also born in Japan, and are of full Japanese descent.
- Second-generation participants born outside of Japan must have two parents and four grandparents born in Japan and are of full Japanese descent.
- History of any clinically significant illness/infection/major febrile illness, hospitalization, or any surgical procedure within 30 days prior to the first dose of study drug.
- Consumption of alcohol, grapefruit products, Seville oranges, starfruit products or quinine/tonic water within the 72-hour period prior to study drug administration.
- Use of tobacco or nicotine-containing products within 180 days prior to the first dose of study drug.
애브비연구 대표 연락처
연락처: ABBVIE CALL CENTER, 844-663-3742, [email protected]
1 1개국에 임상시험 장소
Illinois
Acpru /Id# 270279, Grayslake, Illinois, 60030, United States
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