Human Mass Balance Study of [¹⁴C]HRS-1893
2026年6月15日 更新者: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.
調査の概要
研究の種類
介入
入学 (推定)
6
段階
- フェーズ 1
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前:Wenzheng Xiong
- 電話番号:+86-0518-82342973
- メール:wenzheng.xiong.wx10@hengrui.com
研究連絡先のバックアップ
- 名前:Jing He
- 電話番号:+86-0518-82342973
- メール:jing.he@hengrui.com
研究場所
-
-
Jiangsu
-
Wuxi、Jiangsu、中国、214100
- Jiangnan University Affiliated Hospital
-
コンタクト:
- Yiqing Zhao
- 電話番号:+86-0510-88682779
- メール:13358100007@126.com
-
主任研究者:
- Yiqing Zhao
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
健康ボランティアの受け入れ
はい
説明
Inclusion Criteria:
- Age range: 18 - 45 years old (inclusive of the boundaries, based on the date of signing the informed consent form). Healthy male.
- Body Mass Index (BMI) ranging from 19 to 26 kg/m2 (including the boundary values), with a weight of ≥ 50.0 kg.
- 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.
- The 12-lead electrocardiogram shows no clinically significant abnormalities (among which QTc Fridericia (QTcF) must be < 450 ms).
- Understand the research procedures and methods, voluntarily participate in this trial, and sign the informed consent form in person.
Exclusion Criteria:
- 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.
- 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.
- There is a history of syncope in the past.
- 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.
- 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.
- 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.
- Habitual constipation or diarrhea.
- 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.
- 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.
- 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.
- 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).
- Those who received the vaccine within the previous 1 month or during the trial period or within 1 month after administration.
- 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.
- Staff members of the research center or other individuals directly involved in the implementation of the plan.
- 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.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:処理
- 割り当て:なし
- 介入モデル:単一グループの割り当て
- マスキング:なし(オープンラベル)
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的:[14C]HRS-1893 Group
[14C]HRS-1893.
|
[14C]HRS-1893 suspension.
|
この研究は何を測定していますか?
主要な結果の測定
結果測定 |
時間枠 |
|---|---|
|
Total radioactivity ratio of whole blood/plasma
時間枠:0 to anticipated 11 days.
|
0 to anticipated 11 days.
|
|
Time to reach maximum concentration (Tmax)
時間枠:0 to anticipated 11 days.
|
0 to anticipated 11 days.
|
|
Maximum concentration (Cmax)
時間枠: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)
時間枠:0 to anticipated 11 days.
|
0 to anticipated 11 days.
|
|
Area under the plasma concentration-time curve from Time 0 to infinity (AUC0-∞)
時間枠:0 to anticipated 11 days.
|
0 to anticipated 11 days.
|
|
Half-life (t1/2)
時間枠:0 to anticipated 11 days.
|
0 to anticipated 11 days.
|
|
Apparent clearance (CL/F)
時間枠:0 to anticipated 11 days.
|
0 to anticipated 11 days.
|
|
Apparent volume of distribution (V/F)
時間枠: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)
時間枠: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)
時間枠:0 to anticipated 11 days.
|
0 to anticipated 11 days.
|
|
Total radioactivity ratio for blood/plasma
時間枠: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
時間枠:0 to anticipated 11 days.
|
0 to anticipated 11 days.
|
二次結果の測定
結果測定 |
時間枠 |
|---|---|
|
Safety and tolerability as measured by incidence of adverse events (AEs) and serious AEs
時間枠:0 to anticipated 11 days.
|
0 to anticipated 11 days.
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
2026年6月1日
一次修了 (推定)
2026年7月1日
研究の完了 (推定)
2026年7月1日
試験登録日
最初に提出
2026年6月15日
QC基準を満たした最初の提出物
2026年6月15日
最初の投稿 (実際)
2026年6月18日
学習記録の更新
投稿された最後の更新 (実際)
2026年6月18日
QC基準を満たした最後の更新が送信されました
2026年6月15日
最終確認日
2026年6月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。