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
Not provided
Not provided
Not provided
The primary objectives of this study are to evaluate the safety and tolerance of single and multiple oral administration of PA3670 tablets in Chinese adult healthy subjects and the effect of food on pharmacokinetics of PA3670 tablets in Chinese adult healthy subjects.
Stage I: Single dose, Single Ascending Dose (SAD) This is a randomized, double-blind, placebo-controlled, dose-escalation clinical trial.
The objective is to evaluate the safety, tolerability and pharmacokinetics characteristics of PA3670 tablets in Chinese healthy subjects. There are three dose groups of PA3670(5 mg、15 mg、30 mg) proposed to be tested sequentially in this study. A total of 30 healthy subjects are planned to be enrolled in this study and will be randomly assigned to the corresponding dose group in equal proportion, stratified by gender (male vs female). 10 subjects in each dose group are randomly assigned in a ratio of 4:1 to receive PA3670 tablets or placebo. All subjects will be dosed in a single dose, and the dose-related safety, tolerability and PK of PA3670 will be evaluated.
Stage Ⅱ: Multiple dose This is a randomized, double-blind, placebo-controlled, multiple dose clinical trial. A total of 10 subjects are planned to be enrolled in this study and will be randomly assigned in a ratio of 4:1 to receive 15mg PA3670 tablets or placebo. All subjects will be dosed for 9 consecutive days, and safety, tolerability and PK of PA3670 will be evaluated.
Stage Ⅲ: Study on the effect of food on Pharmacokinetics This is a randomized, open, two group crossover clinical trial. A total of 20 subjects are planned to be enrolled in this study, and will be randomly assigned to a dosing order (i.e. fasting administration followed by high-fat meal administration, or high-fat meal administration followed by fasting administration) in a ratio of 1:1. Subjects will be dosed 15 mg PA3670 tablets in a single dose, and the food-related PK of PA1010 will be evaluated.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PA3670 5 mg | Placebo Comparator | Ten subjects will be randomly assigned in a ratio of 4:1 to receive 5 mg of PA3670 tablets or PA3670 placebo tablets. They will be administered a single dose and observed for four days. |
|
| PA3670 15 mg | Placebo Comparator | Ten subjects will be randomly assigned in a ratio of 4:1 to receive 15 mg of PA3670 tablets or PA3670 placebo tablets. They will be administered a single dose and observed for four days. |
|
| PA3670 30 mg | Placebo Comparator | Ten subjects will be randomly assigned in a ratio of 4:1 to receive 30 mg of PA3670 tablets or PA3670 placebo tablets. They will be administered a single dose and observed for four days. |
|
| PA3670 15 mg for 9days | Placebo Comparator | Ten subjects will be randomly assigned at a 4: 1 ratio to receive either 15mg of PA3670 tablets or PA3670 placebo tablets, once daily for 9 days. |
|
| PA3670 15mg before and after meals | Other | Ten subjects will be administered 15mg PA3670 after overnight fasting for 10 hours in the first cycle, and then will be administered 10mg PA3670 within 30 minutes after high-fat meal in the second cycle. They will receive a single dose in each cycle and will be observed for four days. The cleaning period between the two cycles is more than 7 days. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PA3670 | Drug | Placebo as control |
|
| Measure | Description | Time Frame |
|---|---|---|
| Body temperature | Vital sign-body temperature | Up to 72 hours after last dose |
| Systolic and diastolic blood pressure | Vital sign-Systolic and diastolic blood pressure | Up to 72 hours after last dose |
| Pulse rate | Vital sign-Pulse rate | Up to 72 hours after last dose |
| Breathing rate | Vital sign-Breathing rate | Up to 72 hours after last dose |
| Number of subjects having abnormal hematology laboratory parameters | Absolute and relative number of subjects with values below, within or above the normal range will be assessed. | Up to 72 hours after last dose |
| Number of subjects with abnormal clinical chemistry parameters | Absolute and relative number of subjects with values below, within or above the normal range will be assessed. | Up to 72 hours after last dose |
| Number of subjects with abnormal values for urinalysis | Absolute and relative number of subjects with values below, within or above the normal range will be assessed. | Up to 72 hours after last dose |
| Number of subjects with abnormal with blood coagulation function |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics of PA3670-Cmax | Blood samples will be collected serially, and the concentrations of PA3670 in plasma samples are determined by liquid chromatography/mass spectrometry/mass spectrometry (LC/MS/MS), followed by the calculation of pharmacokinetic parameter Maximum Observed Plasma Concentration (Cmax) | 4 days or 12 days |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Hong Ren, MD | The Second Affiliated Hospital of Chongqing Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Second Affiliated Hospital of Chongqing Medical University | Chongqing | Chongqing Municipality | 400010 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
|
| PA3670 15mg after and before meals | Other | Ten subjects will be administered 15mg PA3670 within 30 minutes after the high-fat meal in the first cycle, and then will be administered 10mg PA3670 after overnight fasting 10 hours in the second cycle. They will receive a single dose in each cycle and will be observed for four days. The cleaning period between the two cycles is more than 7 days. |
|
Absolute and relative number of subjects with values below, within or above the normal range will be assessed. |
| Up to 72 hours after last dose |
| ECG parameter-QTc interval | A 12-lead electrocardiogram (ECG) will be recorded using an ECG machine that automatically measures QTc interval | Up to 72 hours after last dose |
| ECG parameter-PR interval | A 12-lead electrocardiogram (ECG) will be recorded using an ECG machine that automatically measures PR interval. | Up to 72 hours after last dose |
| ECG parameter-QRS duration | A 12-lead electrocardiogram (ECG) will be recorded using an ECG machine that automatically measures QRS duration | Up to 72 hours after last dose |
| Number of subjects experiencing adverse events (AEs) | An adverse event (AE) is defined as any untoward medical occurrence in a clinical study subject administered a medicinal product which does not necessarily have a causal relationship with this treatment. | 7 days or 15 days |
| Pharmacokinetics of PA3670-Tmax |
Blood samples will be collected serially, and the concentrations of PA3670 in plasma samples are determined by liquid chromatography/mass spectrometry/mass spectrometry (LC/MS/MS), followed by the calculation of pharmacokinetic parameter Time to Reach Maximum Observed Plasma Concentration (Tmax) |
| 4 days or 12 days |
| Pharmacokinetics of single dose of PA3670-AUC | Blood samples will be collected serially, and the concentrations of PA3670 in plasma samples are determined by liquid chromatography/mass spectrometry/mass spectrometry (LC/MS/MS), followed by the calculation of pharmacokinetic parameter Area Under the Plasma Concentration-Time Curve (AUC) | 4 days or 12 days |