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Study on the Mass Balance of [14C]HRS-9190 for Injection in Healthy Participants 第I相・フェーズ1 6

募集準備中
治験（臨床試験）の詳細は主に英語で提供されていますが、治験レーダーAIがサポートします！「治験解説」をクリックして、選択した言語で試験情報を表示し、議論してください。
治験番号 NCT07494175 は 治療 の研究で、Healthy Adult Male に関するものです。この 第I相・フェーズ1 介入研究 臨床試験 は現在 募集準備中 で、2026年3月1日 に開始予定です。6 名の参加者 の募集が計画されています。この試験は 恒瑞医薬 によって主導され、2026年4月1日 に完了予定です。ClinicalTrials.gov からの最新更新日は 2026年3月27日 です。
概要
To evaluate the absorption, metabolism and excretion after a single intravenous bolus of \[14C\]HRS-9190 in healthy Participants
公式タイトル

Study on the Mass Balance of [14C]HRS-9190 for Injection in Healthy Participants

疾患名
Healthy Adult Male
その他の研究識別子
  • HRS-9190-103
NCT番号
NCT07494175
開始日
2026-03
最終更新日
2026-03-27
終了予定日
2026-04
目標参加者数
6
試験の種類
介入研究
治験の相・段階
第I相・フェーズ1
状況
募集準備中
主目的
治療
割付方法
該当なし
介入モデル
単一群割当
盲検化
なし（非盲検）
群（アーム）／介入
参加グループ/群介入/治療法
実験的Treatment group A: [14C] HRS-9190
[14C] HRS-9190
\[14C\] HRS-9190 for injection
主要評価項目
評価指標指標の説明時間枠
Total radioactive recovery rate and cumulative total radioactive recovery rate of excreta
From 0 to 120 hours after dosing
Percentage of unchanged HRS-9190 and its metabolites in the total radioactive exposure in plasma
From 0 to 120 hours after dosing
Percentage of unchanged HRS-9190 and its metabolites in urine and feces relative to the administered dose
From 0 to 120 hours after dosing
List of metabolites identified in plasma, urine, and feces
From 0 to 120 hours after dosing
Total radioactive pharmacokinetic parameter Tmax
From 0 to 120 hours after dosing
Total radioactive pharmacokinetic parameter Cmax
From 0 to 120 hours after dosing
Total radioactive pharmacokinetic parameter t1/2
From 0 to 120 hours after dosing
Total radioactive pharmacokinetic parameter MRT
From 0 to 120 hours after dosing
Total radioactive pharmacokinetic parameter AUC
From 0 to 120 hours after dosing
The whole blood-plasma radioactive distribution ratio
From 0 to 120 hours after dosing
副次評価項目
評価指標指標の説明時間枠
Adverse events
up to 13 days postdose
Plasma concentration of HRS-9190 (metabolites, if necessary)
From 0 to 120 hours after dosing
参加アシスタント
適格基準

対象年齢
成人
試験の最低年齢
18 Years
対象性別
男性
健康なボランティアを受け入れる
はい
  1. The participants have been fully informed of the nature, significance, potential benefits, possible inconveniences, and potential risks and discomforts of the trial prior to its commencement.
  2. Male participants aged between 18 and 45 years old (inclusive);
  3. ASA =I;
  4. Male participants with a body weight of ≥ 50 kg and a body mass index (BMI = weight (kg)/height² (m²)) ranging from 19 to 28 kg/m² (inclusive) during the screening period;
  5. Male participants must agree to use highly effective contraception and refrain from donating semen from the time of signing the informed consent form until 4 months after the last administration of the investigational product.

  1. Participants with a history of or current acute or chronic clinical diseases
  2. Participants with a history of neuromuscular diseases;
  3. Participants with a history of anesthetic complications;
  4. Participants with a history of airway diseases;
  5. Participants who have undergone major surgery within 6 months prior to screening;
  6. During the screening or baseline period: participants with clinically significant abnormal physical examination findings as judged by the investigator;
  7. Participants who test positive for one or more of the following: hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (anti-HCV), syphilis antibody, or human immunodeficiency virus antibody (anti-HIV);
  8. Participants with a known history of allergy to the study drug; a history of anaphylactic shock; or atopic diathesis;
  9. Participants with contraindications to anesthetic agents;
  10. Participants who use hepatic enzyme inhibitors/inducers (within 1 month prior to dosing), vaccines (within 1 month pre-screening or planned during trial), or any drugs/health products (within 7 half-lives or 14 days pre-dosing);
  11. Participants who have participated in other clinical trials and received investigational products within 3 months prior to screening, or plan to participate in other clinical trials during the trial period;
  12. Participants with history of significant blood loss/transfusion (≥400 mL within 3 months), active tobacco (>5 cigarettes/day), excessive alcohol/coffee consumption, use of interfering substances (e.g., grapefruit, caffeine) within 48h prior to dosing, or evidence of drug abuse;
  13. Participants with difficult venous access;
  14. Occupational radiation workers; individuals with ≥2 CTs or ≥3 X-rays in the past year; participants in radiolabeled trials (within 1 year);
  15. Participants who may be unable to complete the study for other reasons or are deemed unsuitable for enrollment by the investigator.
Jiangsu HengRui Medicine Co., Ltd. logo恒瑞医薬143 件のアクティブな治験を探索
試験中央連絡先
連絡先: Yuanyuan Huang, +0518-81220121, [email protected]
1 1カ国の場所

Shandong

First Affiliated Hospital of Shandong First Medical University (Shandong Provincial Qianfoshan Hospital), Jinan, Shandong, 250014, China
Wei Zhao, 主任研究者
Jianbo Wu, 主任研究者