A Phase I Study to Evaluate the Food Effect on Ecnoglutide Tablet
A Randomized, Open-label, Multiple-dose, Multicenter Phase I Study to Evaluate the Food Effect on the Pharmacokinetics of Ecnoglutide Tablets in Chinese Adult Participants
The aim of the study is to evaluate food effect on pharmacokinetics of oral ecnoglutide tablets in Chinese participants
調査の概要
詳細な説明
There are two parts in this study. Part I will assess the effect of high-fat meal, while eligible participants will be randomized and allocated to either cohort F1(fasting) or F2(with meal) in a ratio of 1:1 to receive oral ecnoglutide tablet for up to 14 days. Part II will assess the effect of different dosing conditions, while eligible participants will be randomized and allocated to either cohort T1(no intake after 30min of dosing) or T2(no intake after 60min of dosing) in a ratio of 1:1 to receive oral ecnoglutide tablet for up to 14 days.
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:Yao Li
- 電話番号:010-67889253
- メール:ra@sciwindbio.com
研究場所
-
-
Zhejiang
-
Hangzhou、Zhejiang、中国
- Zhejiang Provincial People's Hospital
-
コンタクト:
- Yiwen Zhang
- 電話番号:0571-85893643
- メール:ra@sciwindbio.com
-
-
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:
- Body mass index (BMI): 19.0 kg/m² ≤ BMI < 30.0 kg/m², with body weight ≥ 55 kg (male) or ≥ 50 kg (female);
- Participants of childbearing potential agree to have no plans for pregnancy during the entire study period and within 6 months after the last dose: female participants must be non-pregnant and non-lactating, with no plans to donate ova, and male participants must have no plans to donate sperm; all participants voluntarily use effective contraception, with female participants avoiding pregnancy and male participants avoiding causing pregnancy in their partners;
Exclusion Criteria:
- History of severe drug allergy (especially known or suspected allergy to any component of Ecnoglutide Tablets, regardless of the severity of previous allergic reactions), or severe atopic allergic disease/history (e.g., asthma, urticaria, eczematous dermatitis, etc.), or discretion by the investigator to have a severe allergic condition (e.g., allergy to two or more drugs/foods, or repeated allergic reactions requiring medical intervention);
- Diagnosis of overweight or obesity of endocrine origin, such as Cushing's syndrome;
- Diagnosis of diabetes mellitus of any type (excluding gestational diabetes mellitus);
- History of acute or chronic pancreatitis, pancreatic injury, symptomatic biliary disease, or other high-risk factors that may lead to pancreatitis;
- Diagnosis of other endocrine diseases of significant clinical significance, including but not limited to hyperthyroidism or hypothyroidism, thyroid nodules (imaging showing C-TIRADS ≥ 4A), thyroid cancer, or a personal or family history of multiple endocrine neoplasia type 2 (MEN2);
- Occurrence of severe gastrointestinal diseases, including but not limited to inflammatory bowel disease, active ulcers, severe irritable bowel syndrome, celiac disease, recurrent dyspepsia, or clinically abnormal gastric emptying (e.g., pyloric obstruction), within 6 months prior to screening; or presence of gastrointestinal symptoms such as nausea, vomiting, diarrhea, or constipation at screening/before the first dose;
- Occurrence of severe hypoglycemia or recurrent symptomatic hypoglycemia (≥ 2 episodes within 6 months) (e.g., anxiety, dizziness, sweating, tremor, hunger, and poor concentration, etc.), within 6 months prior to screening;
- Diagnosis of malignant tumor within 5 years, except for cured basal cell carcinoma of the skin, cervical carcinoma in situ, etc., as discreted by the investigator to be clinically insignificant;
- History of depression, or other severe psychiatric illness, or suicidal ideation or suicidal behavior;
- Within 3 months prior to screening, participation in and use of any investigational drug, vaccine, special medical food, or invasive device clinical trial, or planned participation in other clinical trials during the study period;
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:処理
- 割り当て: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 |
|---|---|
|
実験的:F1
Day 1 to Day 14: Fast overnight for at least 10 hours before each dose, and take the tablet with 240 mL of plain water. No food intake is allowed within 4h after dose administration. |
oral, once daily for 7 days oral, once daily for 7 days |
|
実験的:F2
Day 1 to Day 13: take breakfast within 30min before each dose, and then take the tablet with 240 mL of plain water. No food intake is allowed within 4h after dose administration. Day 14: take breakfast with high fat and high calorie |
oral, once daily for 7 days oral, once daily for 7 days |
|
実験的:T1
Day 1 to Day 14: fast after 30min of dosing |
oral, once daily for 7 days oral, once daily for 7 days |
|
実験的:T2
Day 1 to Day 14: fast after 60min of dosing |
oral, once daily for 7 days oral, once daily for 7 days |
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 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Maximum concentration
時間枠:From Day1 to Day42
|
Cmax of ecnoglutide |
From Day1 to Day42
|
|
Minimum concentration
時間枠:From Day1 to Day42
|
Cmin of ecnoglutide |
From Day1 to Day42
|
|
Area under the curve from time 0 to infinity
時間枠:From Day1 to Day42
|
AUC0-∞of ecnoglutide |
From Day1 to Day42
|
|
Area under the curve from time 0 to 24h
時間枠:From Day1 to Day42
|
AUC0-24h of ecnoglutide |
From Day1 to Day42
|
|
Area under the curve from time 0 to last quantifiable time point
時間枠:From Day1 to Day42
|
AUC0-t of ecnoglutide |
From Day1 to Day42
|
|
Time to reach maximum concentration
時間枠:From Day1 to Day42
|
Tmax of ecnoglutide |
From Day1 to Day42
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
The incidence of adverse events
時間枠:From Day1 to Day42
|
From Day1 to Day42
|
|
|
Anti-drug antibody
時間枠:From Day1 to Day42
|
ADA of ecnoglutide |
From Day1 to Day42
|
協力者と研究者
捜査官
- 主任研究者:Yiwen Zhang、Zhejiang 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
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