A Phase I Study of INT-210 Capsules in Healthy Adult Subjects (INT-210-I101) (INT-210-I101)
2026年5月27日 更新者：Innatus Therapeutics (Shanghai) Co., Ltd.
A Phase I, Single and Multiple Ascending Dose Escalation, and Food-Effect Study of the Safety, Tolerability and Pharmacokinetics of INT-210 Capsules in Healthy Adult Subjects
A Phase Ⅰ, Single and Multiple Ascending Dose escalation, and Food-Effect Study of the Safety, Tolerability and Pharmacokinetics of INT-210 Capsules in Healthy Adult Voluteers.
Primary Objectives:
● To assess the safety and tolerability of single and multiple oral dose of INT-210 capsules in healthy adult voluteers,
Secondary Objectives:
- To assess the pharmacokinetic(PK) profile of single and multiple oral doses of INT-210 capsules in healthy adult voluteers;
- To assess the safety and tolerability of INT-210 capsulese administered under fasting and fed(high-fat-meal) conditions in healthy adult voluteers;
- To assess the effect of food on the PK profile of a single oral dose of INT-210 capsules in healthy adult voluteers;
調査の概要
研究の種類
介入
入学 (実際)
86
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。
研究場所
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Beijing、中国
- Beijing Municipality - Beijing Municipality - No. 101, Luyuan East Road, Tongzhou District, Beijing
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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:
- Male or female healthy voluteers
- Aged 18-45 years(inclusive),
- In good general health with no evidence of active or chronic disease; and who agree to comply with the prescribed contraceptive requirement during the trial and for 3 months after the last dose.
Exclusion Criteria:
- Female who are pregnant or breastfeeding; or planing pregnancy, female of chidbearing potential not using adequate contraception.
- Pre-existing significant medical conditions(cardiac, hepatic, renal, gastrointestina, etc), abnormal lab results, active infection, or history of special conditions like long QT syndrome or hypocalcemia.
- Positive screening for HIV, Hepatitis B/C or syphilis;
- Recent subject in another clinical trial;
- Recent major surgery, or significant blood loss.
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：ランダム化
- 介入モデル：並列代入
- マスキング：トリプル
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：Single Ascending Dose from 50 mg to 800 mg
Single Ascending Dose
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400 mg INT-210; Oral administration
Escalating doses of 50, 100, 200, 400, 600, 800 mg of INT-210; Single dose administration; Oral administration
Escalating doses of 200, 400, 600 mg of INT-210; BID; Oral administration
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実験的：Food Effect: 400mg
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400 mg INT-210; Oral administration
Escalating doses of 50, 100, 200, 400, 600, 800 mg of INT-210; Single dose administration; Oral administration
Escalating doses of 200, 400, 600 mg of INT-210; BID; Oral administration
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実験的：Multiple Ascending Dose: 200 mg to 600mg
BID
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400 mg INT-210; Oral administration
Escalating doses of 50, 100, 200, 400, 600, 800 mg of INT-210; Single dose administration; Oral administration
Escalating doses of 200, 400, 600 mg of INT-210; BID; Oral administration
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プラセボコンパレーター：Placebo
Placebo for SAD, MAD and Food Effect
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INT-210 Placebo BID
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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 |
|---|---|---|
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The incidence of treatment-emergent adverse events
時間枠：From Day 1 through the safety follow-up visit on either Day 8 (SAD) or Day 21 (MAD)
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Number of participants with treatment-related adverse events as assessed.
The incidence of treatment-emergent adverse events will be measured using a combination of data collection methods, including tracking adverse events and assessing their onset or worsening relative to the initiation of treatment.
The most recent version of the Medical Dictionary for Regulatory Activities (MedDRA) preferred terms will be used to classify adverse events, including their relationship to the treatment and maximum severity.
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From Day 1 through the safety follow-up visit on either Day 8 (SAD) or Day 21 (MAD)
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Treatment-emergent potentially clinically- significant abnormalities in safety laboratory parameters-hematology
時間枠：From enrollment through the safety follow-up visit on either Day 8 (SAD) or Day 21 (MAD)
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Hemoglobin, Hematocrit, Erythrocytes, Mean corpuscular volume, Platelets, Leukocytes, Eosinophils, Basophils, Neutrophils, Lymphocytes, Monocytes
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From enrollment through the safety follow-up visit on either Day 8 (SAD) or Day 21 (MAD)
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Treatment-emergent potentially clinically significant abnormalities in safety laboratory parameters: coagulation
時間枠：From enrollment through the safety follow-up visit on either Day 8 (SAD) or Day 21 (MAD)
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Activated partial thromboplastin time, Prothrombin time, International Normalized Ratio, Fibrinogen
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From enrollment through the safety follow-up visit on either Day 8 (SAD) or Day 21 (MAD)
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Treatment-emergent potentially clinically significant abnormalities in safety laboratory parameters: serum chemistry
時間枠：From enrollment through the safety follow-up visit on either Day 8 (SAD) or Day 21 (MAD)
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Glucose, Blood urea nitrogen, Creatinine, Sodium, Potassium, Calcium, Chloride, Magnesium, Bicarbonate, Phosphate, Bilirubin, total and direct, Alkaline phosphatase, Aspartate transaminase (=SGOT), Alanine transaminase (=SGPT), Gamma glutamyl transferase, Total protein, Albumin, Creatine kinase, Lactate dehydrogenase (LDH)
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From enrollment through the safety follow-up visit on either Day 8 (SAD) or Day 21 (MAD)
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Treatment-emergent potentially clinically significant abnormalities in safety laboratory parameters: urinalysis
時間枠：From enrollment through the safety follow-up visit on either Day 8 (SAD) or Day 21 (MAD)
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Specific gravity, PH, Glucose, Protein, Nitrite , Urobilinogen, Occult Blood, White blood cells, Ketones, Red blood cells
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From enrollment through the safety follow-up visit on either Day 8 (SAD) or Day 21 (MAD)
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Treatment-emergent potentially clinically significant abnormalities in electrocardiogram values: QTcF (milliseconds)
時間枠：From enrollment through the safety follow-up visit on either Day 8 (SAD) or Day 21 (MAD)
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ECG assessment (QTcF) as determined by the Investigator/consulting board-certified cardiologist
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From enrollment through the safety follow-up visit on either Day 8 (SAD) or Day 21 (MAD)
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Treatment-emergent potentially clinically significant abnormalities in vital signs: heart rate (beats per minute)
時間枠：From enrollment through the safety follow-up visit on either Day 8 (SAD) or Day 21 (MAD)
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From enrollment through the safety follow-up visit on either Day 8 (SAD) or Day 21 (MAD)
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Treatment-emergent potentially clinically significant abnormalities in vital signs: blood pressure (mmHg)
時間枠：From enrollment through the safety follow-up visit on either Day 8 (SAD) or Day 21 (MAD)
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From enrollment through the safety follow-up visit on either Day 8 (SAD) or Day 21 (MAD)
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Treatment-emergent potentially clinically significant abnormalities in vital signs: respiration rate (BPM)
時間枠：From enrollment through the safety follow-up visit on either Day 8 (SAD) or Day 21 (MAD)
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From enrollment through the safety follow-up visit on either Day 8 (SAD) or Day 21 (MAD)
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Treatment-emergent potentially clinically significant abnormalities in vital signs: hemoglobin saturation (%)
時間枠：From enrollment through the safety follow-up visit on either Day 8 (SAD) or Day 21 (MAD)
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From enrollment through the safety follow-up visit on either Day 8 (SAD) or Day 21 (MAD)
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Treatment-emergent potentially clinically significant abnormalities in vital signs: temperature (℃)
時間枠：From enrollment through the safety follow-up visit on either Day 8 (SAD) or Day 21 (MAD)
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From enrollment through the safety follow-up visit on either Day 8 (SAD) or Day 21 (MAD)
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Pharmacokinetics parameter: Cmax of INT-210
時間枠：SAD: From Day 1 to Day 4; MAD: From Day 1 to Day 13; Food Effect: From Day 1 to Day 11
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Maximum observed plasma concentration (ng/mL)
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SAD: From Day 1 to Day 4; MAD: From Day 1 to Day 13; Food Effect: From Day 1 to Day 11
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Pharmacokinetics parameter: Tmax of INT-210
時間枠：SAD: From Day 1 to Day 4; MAD: From Day 1 to Day 13; Food Effect: From Day 1 to Day 11
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Time of maximum observed concentration (Tmax) of INT-210
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SAD: From Day 1 to Day 4; MAD: From Day 1 to Day 13; Food Effect: From Day 1 to Day 11
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Pharmacokinetics parameter: AUC (0-T) of INT-210
時間枠：SAD: From Day 1 to Day 4; MAD: From Day 1 to Day 13; Food Effect: From Day 1 to Day 11
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Area Under the concentration-time curve from dosing to the time of the last measured concentration (AUC0-T) (h*ng/L) of INT-210
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SAD: From Day 1 to Day 4; MAD: From Day 1 to Day 13; Food Effect: From Day 1 to Day 11
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Pharmacokinetics parameter: T1/2 of INT-210
時間枠：SAD: From Day 1 to Day 4; MAD: From Day 1 to Day 13; Food Effect: From Day 1 to Day 11
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Half-life (T1/2) (hours) of INT-210
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SAD: From Day 1 to Day 4; MAD: From Day 1 to Day 13; Food Effect: From Day 1 to Day 11
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Pharmacokinetics parameter: CL/F of INT-210
時間枠：SAD: From Day 1 to Day 4; MAD: From Day 1 to Day 13; Food Effect: From Day 1 to Day 11
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Apparent clearance (L/h) of INT-210
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SAD: From Day 1 to Day 4; MAD: From Day 1 to Day 13; Food Effect: From Day 1 to Day 11
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Pharmacokinetics parameter: Vz/F of INT-210
時間枠：SAD: From Day 1 to Day 4; MAD: From Day 1 to Day 13; Food Effect: From Day 1 to Day 11
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Apparent volume of distribution (L) of INT-210
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SAD: From Day 1 to Day 4; MAD: From Day 1 to Day 13; Food Effect: From Day 1 to Day 11
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Pharmacokinetics parameter: AUCinf of INT-210
時間枠：SAD: From Day 1 to Day 4; MAD: From Day 1 to Day 13; Food Effect: From Day 1 to Day 11
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Area under the curve from time 0 extrapolated to infinite time (AUCinf) (h*ng/L) of INT-210
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SAD: From Day 1 to Day 4; MAD: From Day 1 to Day 13; Food Effect: From Day 1 to Day 11
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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Potential risk of QT/QTc interval prolongation of INT-210
時間枠：SAD: From Day 1 to Day 4; MAD: From Day 1 to Day 13; Food Effect: From Day 1 to Day 11
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A correlation model will be constructed using drug concentrations and ECG parameters to analyze the concentration-QTc relationship, and the potential risk of QT/QTc interval prolongation will be assessed by establishing a "concentration-effect model".
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SAD: From Day 1 to Day 4; MAD: From Day 1 to Day 13; Food Effect: From Day 1 to Day 11
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Fraction excreted: Fraction of drug excreted unchanged in urine and Feces
時間枠：SAD: From Day 1 to Day 4; MAD: From Day 1 to Day 13; Food Effect: From Day 1 to Day 11
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Fraction of dose excreted unchanged into urine and feces as a percentage (%)
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SAD: From Day 1 to Day 4; MAD: From Day 1 to Day 13; Food Effect: From Day 1 to Day 11
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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 (実際)
2025年9月4日
一次修了 (実際)
2026年1月6日
研究の完了 (実際)
2026年1月6日
試験登録日
最初に提出
2026年4月24日
QC基準を満たした最初の提出物
2026年5月27日
最初の投稿 (実際)
2026年6月1日
学習記録の更新
投稿された最後の更新 (実際)
2026年6月1日
QC基準を満たした最後の更新が送信されました
2026年5月27日
最終確認日
2026年5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。