Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| CTR20253467 | Other Identifier | National Medical Products Administration (NMPA) |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Ascending Dose from 50 mg to 800 mg | Experimental | Single Ascending Dose |
|
| Food Effect: 400mg | Experimental |
| |
| Multiple Ascending Dose: 200 mg to 600mg | Experimental | BID |
|
| Placebo | Placebo Comparator | Placebo for SAD, MAD and Food Effect |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| INT-210 Capsule | Drug | 400 mg INT-210; Oral administration |
| |
| Measure | Description | Time Frame |
|---|---|---|
| The incidence of treatment-emergent adverse events | 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 | 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 | 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 | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics parameter: Cmax of INT-210 | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Potential risk of QT/QTc interval prolongation of INT-210 | 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 |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Municipality - Beijing Municipality - No. 101, Luyuan East Road, Tongzhou District, Beijing | Beijing | China |
Not provided
| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| ID | Term |
|---|---|
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| INT-210 Capsule |
| Drug |
Escalating doses of 50, 100, 200, 400, 600, 800 mg of INT-210; Single dose administration; Oral administration |
|
| INT-210 Capsule | Drug | Escalating doses of 200, 400, 600 mg of INT-210; BID; Oral administration |
|
| INT-210 Placebo | Drug | INT-210 Placebo BID |
|
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) | 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) | 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) | 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) | 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 (%) | 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 (℃) | From enrollment through the safety follow-up visit on either Day 8 (SAD) or Day 21 (MAD) |
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 | 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 | 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 | 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 | 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 | 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 |
| Fraction excreted: Fraction of drug excreted unchanged in urine and Feces | 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 |