A Phase I Study of INT-210 Capsules in Healthy Adult Subjects (INT-210-I101) (INT-210-I101)
27 mai 2026 mis à jour par: 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;
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Réel)
86
Phase
- La phase 1
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
-
-
-
Beijing, Chine
- Beijing Municipality - Beijing Municipality - No. 101, Luyuan East Road, Tongzhou District, Beijing
-
-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
Accepte les volontaires sains
Oui
La description
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.
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Tripler
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Single Ascending Dose from 50 mg to 800 mg
Single Ascending Dose
|
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
|
|
Expérimental: Food Effect: 400mg
|
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
|
|
Expérimental: Multiple Ascending Dose: 200 mg to 600mg
BID
|
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
|
|
Comparateur placebo: Placebo
Placebo for SAD, MAD and Food Effect
|
INT-210 Placebo BID
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
The incidence of treatment-emergent adverse events
Délai: From Day 1 through the safety follow-up visit on either Day 8 (SAD) or Day 21 (MAD)
|
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.
|
From Day 1 through the safety follow-up visit on either Day 8 (SAD) or Day 21 (MAD)
|
|
Treatment-emergent potentially clinically- significant abnormalities in safety laboratory parameters-hematology
Délai: From enrollment through the safety follow-up visit on either Day 8 (SAD) or Day 21 (MAD)
|
Hemoglobin, Hematocrit, Erythrocytes, Mean corpuscular volume, Platelets, Leukocytes, Eosinophils, Basophils, Neutrophils, Lymphocytes, Monocytes
|
From enrollment through the safety follow-up visit on either Day 8 (SAD) or Day 21 (MAD)
|
|
Treatment-emergent potentially clinically significant abnormalities in safety laboratory parameters: coagulation
Délai: From enrollment through the safety follow-up visit on either Day 8 (SAD) or Day 21 (MAD)
|
Activated partial thromboplastin time, Prothrombin time, International Normalized Ratio, Fibrinogen
|
From enrollment through the safety follow-up visit on either Day 8 (SAD) or Day 21 (MAD)
|
|
Treatment-emergent potentially clinically significant abnormalities in safety laboratory parameters: serum chemistry
Délai: From enrollment through the safety follow-up visit on either Day 8 (SAD) or Day 21 (MAD)
|
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)
|
From enrollment through the safety follow-up visit on either Day 8 (SAD) or Day 21 (MAD)
|
|
Treatment-emergent potentially clinically significant abnormalities in safety laboratory parameters: urinalysis
Délai: From enrollment through the safety follow-up visit on either Day 8 (SAD) or Day 21 (MAD)
|
Specific gravity, PH, Glucose, Protein, Nitrite , Urobilinogen, Occult Blood, White blood cells, Ketones, Red blood cells
|
From enrollment through the safety follow-up visit on either Day 8 (SAD) or Day 21 (MAD)
|
|
Treatment-emergent potentially clinically significant abnormalities in electrocardiogram values: QTcF (milliseconds)
Délai: From enrollment through the safety follow-up visit on either Day 8 (SAD) or Day 21 (MAD)
|
ECG assessment (QTcF) as determined by the Investigator/consulting board-certified cardiologist
|
From enrollment through the safety follow-up visit on either Day 8 (SAD) or Day 21 (MAD)
|
|
Treatment-emergent potentially clinically significant abnormalities in vital signs: heart rate (beats per minute)
Délai: From enrollment through the safety follow-up visit on either Day 8 (SAD) or Day 21 (MAD)
|
From enrollment through the safety follow-up visit on either Day 8 (SAD) or Day 21 (MAD)
|
|
|
Treatment-emergent potentially clinically significant abnormalities in vital signs: blood pressure (mmHg)
Délai: From enrollment through the safety follow-up visit on either Day 8 (SAD) or Day 21 (MAD)
|
From enrollment through the safety follow-up visit on either Day 8 (SAD) or Day 21 (MAD)
|
|
|
Treatment-emergent potentially clinically significant abnormalities in vital signs: respiration rate (BPM)
Délai: From enrollment through the safety follow-up visit on either Day 8 (SAD) or Day 21 (MAD)
|
From enrollment through the safety follow-up visit on either Day 8 (SAD) or Day 21 (MAD)
|
|
|
Treatment-emergent potentially clinically significant abnormalities in vital signs: hemoglobin saturation (%)
Délai: From enrollment through the safety follow-up visit on either Day 8 (SAD) or Day 21 (MAD)
|
From enrollment through the safety follow-up visit on either Day 8 (SAD) or Day 21 (MAD)
|
|
|
Treatment-emergent potentially clinically significant abnormalities in vital signs: temperature (℃)
Délai: From enrollment through the safety follow-up visit on either Day 8 (SAD) or Day 21 (MAD)
|
From enrollment through the safety follow-up visit on either Day 8 (SAD) or Day 21 (MAD)
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Pharmacokinetics parameter: Cmax of INT-210
Délai: SAD: From Day 1 to Day 4; MAD: From Day 1 to Day 13; Food Effect: From Day 1 to Day 11
|
Maximum observed plasma concentration (ng/mL)
|
SAD: From Day 1 to Day 4; MAD: From Day 1 to Day 13; Food Effect: From Day 1 to Day 11
|
|
Pharmacokinetics parameter: Tmax of INT-210
Délai: SAD: From Day 1 to Day 4; MAD: From Day 1 to Day 13; Food Effect: From Day 1 to Day 11
|
Time of maximum observed concentration (Tmax) of INT-210
|
SAD: From Day 1 to Day 4; MAD: From Day 1 to Day 13; Food Effect: From Day 1 to Day 11
|
|
Pharmacokinetics parameter: AUC (0-T) of INT-210
Délai: SAD: From Day 1 to Day 4; MAD: From Day 1 to Day 13; Food Effect: From Day 1 to Day 11
|
Area Under the concentration-time curve from dosing to the time of the last measured concentration (AUC0-T) (h*ng/L) of INT-210
|
SAD: From Day 1 to Day 4; MAD: From Day 1 to Day 13; Food Effect: From Day 1 to Day 11
|
|
Pharmacokinetics parameter: T1/2 of INT-210
Délai: SAD: From Day 1 to Day 4; MAD: From Day 1 to Day 13; Food Effect: From Day 1 to Day 11
|
Half-life (T1/2) (hours) of INT-210
|
SAD: From Day 1 to Day 4; MAD: From Day 1 to Day 13; Food Effect: From Day 1 to Day 11
|
|
Pharmacokinetics parameter: CL/F of INT-210
Délai: SAD: From Day 1 to Day 4; MAD: From Day 1 to Day 13; Food Effect: From Day 1 to Day 11
|
Apparent clearance (L/h) of INT-210
|
SAD: From Day 1 to Day 4; MAD: From Day 1 to Day 13; Food Effect: From Day 1 to Day 11
|
|
Pharmacokinetics parameter: Vz/F of INT-210
Délai: SAD: From Day 1 to Day 4; MAD: From Day 1 to Day 13; Food Effect: From Day 1 to Day 11
|
Apparent volume of distribution (L) of INT-210
|
SAD: From Day 1 to Day 4; MAD: From Day 1 to Day 13; Food Effect: From Day 1 to Day 11
|
|
Pharmacokinetics parameter: AUCinf of INT-210
Délai: SAD: From Day 1 to Day 4; MAD: From Day 1 to Day 13; Food Effect: From Day 1 to Day 11
|
Area under the curve from time 0 extrapolated to infinite time (AUCinf) (h*ng/L) of INT-210
|
SAD: From Day 1 to Day 4; MAD: From Day 1 to Day 13; Food Effect: From Day 1 to Day 11
|
Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Potential risk of QT/QTc interval prolongation of INT-210
Délai: SAD: From Day 1 to Day 4; MAD: From Day 1 to Day 13; Food Effect: From Day 1 to Day 11
|
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".
|
SAD: From Day 1 to Day 4; MAD: From Day 1 to Day 13; Food Effect: From Day 1 to Day 11
|
|
Fraction excreted: Fraction of drug excreted unchanged in urine and Feces
Délai: SAD: From Day 1 to Day 4; MAD: From Day 1 to Day 13; Food Effect: From Day 1 to Day 11
|
Fraction of dose excreted unchanged into urine and feces as a percentage (%)
|
SAD: From Day 1 to Day 4; MAD: From Day 1 to Day 13; Food Effect: From Day 1 to Day 11
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
4 septembre 2025
Achèvement primaire (Réel)
6 janvier 2026
Achèvement de l'étude (Réel)
6 janvier 2026
Dates d'inscription aux études
Première soumission
24 avril 2026
Première soumission répondant aux critères de contrôle qualité
27 mai 2026
Première publication (Réel)
1 juin 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
1 juin 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
27 mai 2026
Dernière vérification
1 mai 2026
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- INT-210-I101
- CTR20253467 (Autre identifiant: National Medical Products Administration (NMPA))
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .