A Phase I Study of INT-210 Capsules in Healthy Adult Subjects (INT-210-I101) (INT-210-I101)
2026년 5월 27일 업데이트: 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;
연구 개요
상태
완전한
연구 유형
중재적
등록 (실제)
86
단계
- 1단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Beijing, 중국
- Beijing Municipality - Beijing Municipality - No. 101, Luyuan East Road, Tongzhou District, Beijing
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
건강한 자원 봉사자를 받아들입니다
예
설명
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.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 삼루타
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: 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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실험적: 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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실험적: 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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위약 비교기: Placebo
Placebo for SAD, MAD and Food Effect
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INT-210 Placebo BID
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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The incidence of treatment-emergent adverse events
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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 (%)
기간: 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 (℃)
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Pharmacokinetics parameter: Cmax of INT-210
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Potential risk of QT/QTc interval prolongation of INT-210
기간: 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
기간: 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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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
연구 기록 날짜
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연구 주요 날짜
연구 시작 (실제)
2025년 9월 4일
기본 완료 (실제)
2026년 1월 6일
연구 완료 (실제)
2026년 1월 6일
연구 등록 날짜
최초 제출
2026년 4월 24일
QC 기준을 충족하는 최초 제출
2026년 5월 27일
처음 게시됨 (실제)
2026년 6월 1일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 6월 1일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 5월 27일
마지막으로 확인됨
2026년 5월 1일
추가 정보
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