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임상시험 NCT03103412은(는) Active Mild Ulcerative Colitis, Active Moderate Ulcerative Colitis, Healthy Subjects에 대해 완료 상태입니다. 모든 세부 정보를 보려면 임상시험 레이더 카드 뷰와 AI 발견 도구를 확인하거나 여기에서 무엇이든 물어보세요.
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TD-3504 SAD in Healthy Subjects and Subjects With Ulcerative Colitis (UC) 1상 32 단일 투여

완료
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임상시험 NCT03103412은(는) 치료을(를) 알아보기 위한 연구였습니다. 이 연구는 Active Mild Ulcerative Colitis, Active Moderate Ulcerative Colitis, Healthy Subjects에 대한 것이었으며, 완료 된 1상 중재연구이었습니다. 연구는 2017년 5월 4일에 시작되어 32명의 참여자와 함께 진행되었습니다. 테라반스 바이오파마이(가) 진행한 이 연구는 2017년 11월 8일에 마무리되었습니다. ClinicalTrials.gov의 가장 최근 정보는 2021년 1월 14일에 갱신되었습니다.
간단한 개요
This study is designed to evaluate the safety, tolerability, and pharmacokinetics (PK) of single-dose TD-3504 and single dose 15N2-tofacitinib in healthy subjects and subjects with UC. The relative bioavailability of tofacitinib released from TD-3504 compared to co-administered oral heavy-labeled tofacitinib (15N2-tofacitinib) will also be evaluated.
공식 제목

Study 0146: A Phase 1a, Double-Blinded, Randomized, Placebo Controlled, Single Ascending Dose (SAD) Study to Evaluate the Safety, Tolerability, and Systemic Exposure of TD-3504 in Healthy Subjects and Subjects With Ulcerative Colitis (UC)

질환명
Active Mild Ulcerative Colitis, Active Moderate Ulcerative Colitis, Healthy Subjects
기타 연구 식별자
  • 0146
NCT 번호
NCT03103412
실제 연구 시작일
2017-05-04
최신 업데이트 게시
2021-01-14
예상 연구 완료일
2017-11-08
계획된 등록 인원
32
연구종류
중재연구
단계/상
1상
상태
완료
키워드
Active Mild Ulcerative Colitis, Active Moderate Ulcerative Colitis, Healthy Subjects
주요 목적
치료
설계 할당
무작위배정
중재 모델
평행설계
맹검 (마스킹)
삼중맹검
시험군 / 개입
참가자 그룹/시험군개입/치료
실험적TD-3504 Low-Dose
6 healthy subjects and 6 ulcerative colitis subjects will be randomized to receive low-dose TD-3504 and low-dose of 15N2-tofacitinib orally single dose.
TD-3504
TD-3504
15N2-tofacitinib
15N2-tofacitinib
실험적TD-3504 Mid-Dose
6 healthy subjects will be randomized to receive mid-dose TD-3504 and low-dose of 15N2-tofacitinib orally single dose.
TD-3504
TD-3504
15N2-tofacitinib
15N2-tofacitinib
실험적TD-3504 High-Dose
6 healthy subjects will be randomized to receive high-dose TD-3504 and low-dose of 15N2-tofacitinib orally single dose.
TD-3504
TD-3504
15N2-tofacitinib
15N2-tofacitinib
위약 대조군Placebo
6 healthy subjects and 2 ulcerative colitis subjects to receive placebo orally single dose.
위약
Placebo
주요결과변수
결과변수측정값 설명시간 범위
Safety & tolerability of TD-3504 by assessing the number, severity, and type of adverse events
To assess the safety \& tolerability of TD-3504 following single escalating doses of TD-3504 co-administered with a low dose of 15N2 tofacitinib for 8 days in healthy subjects and subjects with UC by assessing the number, severity, and type of treatment related adverse events.
Day 1 through Day 8
이차결과변수
결과변수측정값 설명시간 범위
Safety & tolerability of TD-3504 by assessing treatment related changes safety laboratory values
To assess the safety \& tolerability of TD-3504 following single escalating doses of TD-3504 co-administered with a low dose of 15N2 tofacitinib for 8 days in healthy subjects and subjects with UC by assessing treatment related changes safety laboratory values.
Day 1 through Day 8
Systemic area under the curve of TD-3504
To assess the systemic exposure of TD-3504 following single escalating doses of TD-3504 and co-administered 15N2-tofacitinib.
Day 1 through Day 4
Systemic Cmax of TD-3504
To assess the systemic exposure of TD-3504 following single escalating doses of TD-3504 and co-administered 15N2-tofacitinib.
Day 1
Systemic area under the curve of tofacitinib
To assess the systemic exposure of tofacitinib following single escalating doses of TD-3504 and co-administered 15N2-tofacitinib.
Day 1 through Day 4
Systemic Cmax of tofacitinib
To assess the systemic exposure of tofacitinib following single escalating doses of TD-3504 and co-administered 15N2-tofacitinib.
Day 1
Systemic area under the curve of 15N2-tofacitinib
To assess the systemic exposure of following single escalating doses of TD-3504 and co-administered 15N2-tofacitinib.
Day 1 through Day 4
Systemic Cmax of 15N2-tofacitinib
To assess the systemic exposure of following single escalating doses of TD-3504 and co-administered 15N2-tofacitinib.
Day 1
Tofacitinib relative bioavailability by area under the curve comparison
To assess the relative bioavailability of tofacitinib from TD-3504 relative to 15N2-tofacitinib.
Day 1 through Day 4
Tofacitinib relative bioavailability by Cmax comparison
To assess the relative bioavailability of tofacitinib from TD-3504 relative to 15N2-tofacitinib.
Day 1
적격성 기준

연령대
성인
최소 연령
18 Years
참여 가능한 성별
전체
건강한 참가자 허용
네
  • Male or female between 18 to 55 years old
  • Male subjects must abstain from sexual intercourse or use a highly effective method of birth control
  • Women of child bearing potential must have a negative pregnancy test and either abstain from sex or use a highly effective method of birth control
  • Body Mass Index (BMI) 18 to 32 kg/m2
  • Willing and able to give informed consent
  • Additional inclusion criteria apply

Inclusion Criteria for Ulcerative Colitis (UC) subjects:

  • Subject has a history of UC
  • Subject is either not taking any medication for UC or has been taking a stable dose of ulcerative colitis medications for ≥ 14 days
  • Additional inclusion criteria apply

  • Is positive for hepatitis A, B or C, HIV or tuberculosis
  • Has clinically significant abnormalities in baseline laboratory evaluations
  • Subject has a clinically significant abnormal electrocardiogram (ECG)
  • Participated in another clinical trial of an investigational drug (or medical device) within 30 days prior to screening (or within 60 days prior to screening if investigational drug was a biologic, or is currently participating in another trial of an investigational drug (or medical device)
  • Additional exclusion criteria apply

Exclusion Criteria for Healthy Subjects:

  • Use of prescription drugs or any chronic over the counter medications within 14 days prior to clinic admission or requires continuing use during study participation, with the exception of hormonal contraceptives or hormone replacement therapy or standard daily multivitamin.
  • Additional exclusion criteria apply
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Anaheim Clinical Trials, LLC, Anaheim, California, 92801, United States