A Study of Zovaglutide (ZT002 Injection) in Participants With Hepatic Impairment and Healthy Participants
A Phase I Clinical Study to Evaluate the Pharmacokinetic Characteristics and Safety of Single Dose of Zovaglutide (ZT002 Injection) in Participants With Varying Degrees of Hepatic Impairment and Matched Participants With Normal Hepatic Function
This study is a single-dose, open-label, non-randomized, parallel design phase I clinical study to evaluate the PK characteristics and safety of single subcutaneous injection of ZT002 Injection in participants with varying degrees of Hepatic Impairment and matched participants with normal hepatic function.
調査の概要
研究の種類
入学 (推定)
段階
- フェーズ 1
連絡先と場所
研究連絡先
- 名前：Donglei Wang
- 電話番号：+8613932155055
- メール：wang.donglei@qlbiopharm.com
研究連絡先のバックアップ
- 名前：Kun Guan
- 電話番号：+8615040353238
- メール：guan.kun@qlbiopharm.com
研究場所
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Chongqing Municipality
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Chongqing、Chongqing Municipality、中国、400000
- The Second Affiliated Hospital of Chongqing Medical University
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コンタクト：
- Xian Yu, Doctor
- 電話番号：18512356862
- メール：22168398@qq.com
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Henan
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Zhengzhou、Henan、中国、450000
- Henan Infectious Diseases Hospital & The Sixth People's Hospital of Zhengzhou
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コンタクト：
- Shuang Li, Master
- 電話番号：13938529645
- メール：li36918@163.com
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Sichuan
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Chengdu、Sichuan、中国、610072
- Sichuan Academy of Medical Science & Sichuan Provincial People's Hospital
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コンタクト：
- Mengchang Yang, Doctor
- 電話番号：18140049936
- メール：ymc681@126.com
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
All participants:
- Male or female subjects aged≥18 years and≤75 years (both inclusive) at the time of signing the Informed Consent Form (ICF).
- Body Mass Index (Body mass index (BMI) 18.0 - 32.0 kg/m² (both inclusive). Body weight ≥50 kg for male participants and ≥45 kg for female participants.
- Ability to understand the trial procedures and possible adverse events, be able and willing to provide a written informed consent.
Participants with Hepatic Impairment:
• Participants with chronic mild and moderate hepatic impairment, assessed by Child-Pugh scoring
Exclusion Criteria:
All participants:
- History of medullary thyroid carcinoma (MTC) or type 2 multiple endocrine neoplasia (MEN2) in personal or family history.
- Those with any type of malignant tumors within 5 years prior to screening (except cured basal cell carcinoma of the skin or carcinoma in situ of the cervix).or any GI disease which impacts gastric emptying
- Have a history of severe GI disease within 6 months before screening , or have received GI surgery (appendectomy, cholecystectomy are excepted), or clinically significant gastric emptying disorders.
- Medical history of hypoglycemia within 6 months before screening;
- eGFR<60 mL/min/1.73m²
Participants with Hepatic Impairment:
- Those with systolic blood pressure exceeding 160 mmHg or diastolic blood pressure exceeding 100 mmHg in the screening period;
- Have a severe portal shunt or prior portosystemic shunt within 3 months before screening;
- Severe ascites and/or pleural effusion requiring paracentesis;
- Have other causes of hepatic injury unrelated to hepatic parenchymal disease and/or cholestatic liver disease at screening;.
- History of acute liver failure, esophagogastric variceal bleeding within 6 months before screening;
- History of Hepatic encephalopathy of Grade 3 or 4.
- Have hemoglobin <70 grams per deciliter (g/L)
- Have platelet <50×10^9/L
- HbA1c ≥ 8.0% or fasting blood glucose ≥ 11.10 mmol/L at screening.
研究計画
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：他の
- 割り当て：非ランダム化
- 介入モデル：並列代入
- 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 |
|---|---|
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実験的：Group A (Mild Hepatic Impairment)
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All subjects will be treated with a single subcutaneous injection of Zovaglutide All subjects will be treated with a single subcutaneous injection of Zovaglutide. |
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実験的：Group B (Moderate Hepatic Impairment)
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All subjects will be treated with a single subcutaneous injection of Zovaglutide All subjects will be treated with a single subcutaneous injection of Zovaglutide. |
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実験的：Group C (Normal hepatic function)
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All subjects will be treated with a single subcutaneous injection of Zovaglutide All subjects will be treated with a single subcutaneous injection of Zovaglutide. |
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 |
|---|---|
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Area Under the Concentration Versus Time Curve (AUC) of ZT002 From Time Zero to Infinity (AUC0-∞)
時間枠：Start of treatment up to Day 36
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Start of treatment up to Day 36
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Maximum Concentration of ZT002 (Cmax)
時間枠：Start of treatment up to Day 36
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Start of treatment up to Day 36
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Area Under the Concentration Versus Time Curve (AUC) of ZT002 From Time Zero to Tlast (AUC0-t)
時間枠：Start of treatment up to Day 36
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Start of treatment up to Day 36
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二次結果の測定
結果測定 |
時間枠 |
|---|---|
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Time to maximum concentration (Tmax)
時間枠：Start of treatment up to Day 36
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Start of treatment up to Day 36
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Apparent terminal half-life (t1/2)
時間枠：Start of treatment up to Day 36
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Start of treatment up to Day 36
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Apparent clearance (CL/F)
時間枠：Start of treatment up to Day 36
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Start of treatment up to Day 36
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Incidence and severity of adverse events
時間枠：Start of treatment up to Day 36
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Start of treatment up to Day 36
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協力者と研究者
捜査官
- 主任研究者：Mengchang Yang, Doctor、Sichuan Academy of Medical Science & Sichuan Provincial People's Hospital
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
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。