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Human Mass Balance Study of [¹⁴C]HRS-1893

2026년 6월 15일 업데이트: Shandong Suncadia Medicine Co., Ltd.
HRS-1893-107 is a Phase 1, single-center, non-randomized, open-label, single-dose study designed to investigate the mass balance, metabolism, and pharmacokinetics of [14C]HRS-1893. The study aims to quantify the radioactive recovery rate, determine the primary excretion pathways, evaluate the whole blood-to-plasma radioactivity ratio, identify major metabolites, and characterize the pharmacokinetic (PK) profile of HRS-1893 and its metabolites. Safety and tolerability will be monitored throughout the trial.

연구 개요

상태

아직 모집하지 않음

정황

연구 유형

중재적

등록 (추정된)

6

단계

  • 1단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 연락처 백업

연구 장소

    • Jiangsu
      • Wuxi, Jiangsu, 중국, 214100
        • Jiangnan University Affiliated Hospital
        • 연락하다:
        • 수석 연구원:
          • Yiqing Zhao

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인

건강한 자원 봉사자를 받아들입니다

설명

Inclusion Criteria:

  1. Age range: 18 - 45 years old (inclusive of the boundaries, based on the date of signing the informed consent form). Healthy male.
  2. Body Mass Index (BMI) ranging from 19 to 26 kg/m2 (including the boundary values), with a weight of ≥ 50.0 kg.
  3. After comprehensive physical examinations (including vital signs, physical examinations, etc.) and laboratory tests (such as blood routine, blood biochemistry, coagulation function, urine routine, fecal routine + occult blood, thyroid function), as well as abdominal B-ultrasound and chest anteroposterior X-ray films, no clinically significant abnormalities were found (ALT, AST, total bilirubin, direct bilirubin, creatine kinase must be < 1.5 times the upper limit of the normal reference value, glomerular filtration rate (eGFR) > 90 mL/(min·1.73 m2)), or the researchers judged that there were minor abnormalities that did not affect the participants' enrollment (such as hemangioma, cyst, calcification focus, nodules, etc.). Among them, abdominal B-ultrasound and chest anteroposterior X-ray films can accept the abdominal B-ultrasound or abdominal CT that can be traced within 6 months before administration, and the results of chest anteroposterior X-ray films or chest CT.
  4. The 12-lead electrocardiogram shows no clinically significant abnormalities (among which QTc Fridericia (QTcF) must be < 450 ms).
  5. Understand the research procedures and methods, voluntarily participate in this trial, and sign the informed consent form in person.

Exclusion Criteria:

  1. Systolic blood pressure (SBP) during the screening period or baseline period: SBP ≥ 140 mmHg or < 90 mmHg; Diastolic blood pressure (DBP): DBP ≥ 90 mmHg or < 60 mmHg, and the clinical doctor determines that it has clinical significance.
  2. During the screening period, any one of the following infectious disease screenings - hepatitis B surface antigen, hepatitis C antibody, syphilis antibody, or human immunodeficiency virus antibody - showing any abnormal result and judged by the researcher to have clinical significance will be included.
  3. There is a history of syncope in the past.
  4. Those who have a history of allergies to drugs, foods, or the environment, or who are allergic to the test drug or any of its components.
  5. Within one month prior to taking the research drug, any prescription drugs, over-the-counter drugs, or herbal medicines were taken; those whose drug half-life was within five half-lives at the time of screening; and those who plan to take non-research trial drugs during the trial period.
  6. Select those who smoked an average of more than 5 cigarettes per day over the past 4 weeks; those who consumed an average of more than 15 grams of alcohol per day in a week (15 grams of alcohol is equivalent to 450 mL of beer or 150 mL of wine or 50 mL of low-alcohol liquor); or those whose alcohol breath test result was greater than 0 mg/100 mL during the screening period; or those who refrained from smoking, drinking alcohol and consuming caffeinated foods or beverages during the screening period and the test period, and had special dietary requirements that they could not comply with the unified diet.
  7. Habitual constipation or diarrhea.
  8. Those with a history of drug use or substance abuse; or those who tested positive for drug abuse in the screening urine test during the selection process.
  9. Those who habitually consume grapefruit juice or excessive amounts of tea, coffee and/or caffeinated beverages, or those who are unable to quit during the trial period.
  10. Those who have a history of fainting during blood collection or blood transfusion, or who have difficulty in blood collection or cannot tolerate venipuncture for blood collection.
  11. Screen those who have participated in any clinical trials of drugs or medical devices within the past three months (the definition of participation in clinical trials is based on the participants receiving treatment with the trial drugs or medical devices).
  12. Those who received the vaccine within the previous 1 month or during the trial period or within 1 month after administration.
  13. Those who had experienced blood loss or blood donation of 400 mL within the past 3 months, or those who received blood transfusion within the past 1 month will be selected.
  14. Staff members of the research center or other individuals directly involved in the implementation of the plan.
  15. The researchers believe that there are other circumstances that make the participants unsuitable for this trial, such as those that might increase the risk of the trial, affect the participants' compliance with the protocol, or cause physical or psychological conditions that prevent them from completing the trial.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 해당 없음
  • 중재 모델: 단일 그룹 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: [14C]HRS-1893 Group
[14C]HRS-1893.
[14C]HRS-1893 suspension.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
기간
Total radioactivity ratio of whole blood/plasma
기간: 0 to anticipated 11 days.
0 to anticipated 11 days.
Time to reach maximum concentration (Tmax)
기간: 0 to anticipated 11 days.
0 to anticipated 11 days.
Maximum concentration (Cmax)
기간: 0 to anticipated 11 days.
0 to anticipated 11 days.
Area under the plasma concentration-time curve from Time 0 to the last quantifiable time point (AUC0-t)
기간: 0 to anticipated 11 days.
0 to anticipated 11 days.
Area under the plasma concentration-time curve from Time 0 to infinity (AUC0-∞)
기간: 0 to anticipated 11 days.
0 to anticipated 11 days.
Half-life (t1/2)
기간: 0 to anticipated 11 days.
0 to anticipated 11 days.
Apparent clearance (CL/F)
기간: 0 to anticipated 11 days.
0 to anticipated 11 days.
Apparent volume of distribution (V/F)
기간: 0 to anticipated 11 days.
0 to anticipated 11 days.
Percentage of parent drug and its metabolites in plasma as a percentage of total radioactive exposure (%AUC)
기간: 0 to anticipated 11 days.
0 to anticipated 11 days.
Percentage of parent drug and its metabolites in urine and feces as a percentage of administered dose (%Dose)
기간: 0 to anticipated 11 days.
0 to anticipated 11 days.
Total radioactivity ratio for blood/plasma
기간: 0 to anticipated 11 days.
0 to anticipated 11 days.
The cumulative recovery amount and recovery rate of total radioactive substances in urine and feces
기간: 0 to anticipated 11 days.
0 to anticipated 11 days.

2차 결과 측정

결과 측정
기간
Safety and tolerability as measured by incidence of adverse events (AEs) and serious AEs
기간: 0 to anticipated 11 days.
0 to anticipated 11 days.

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (추정된)

2026년 6월 1일

기본 완료 (추정된)

2026년 7월 1일

연구 완료 (추정된)

2026년 7월 1일

연구 등록 날짜

최초 제출

2026년 6월 15일

QC 기준을 충족하는 최초 제출

2026년 6월 15일

처음 게시됨 (실제)

2026년 6월 18일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 6월 18일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 6월 15일

마지막으로 확인됨

2026년 6월 1일

추가 정보

이 연구와 관련된 용어

추가 관련 MeSH 약관

기타 연구 ID 번호

  • HRS-1893-107

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

미정

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

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. .

[14C]HRS-1893에 대한 임상 시험

구독하다