The purpose of the study is to assess the safety and tolerability of single and multiple oral doses of Hemay005 tablets in healthy Caucasian adult volunteers.
This is a phase I, single-arm, open-label ethno-bridging study. The study is being conducted to test a potential new treatment for Behçet's disease (BD) called Hemay005. The primary objective of this study is to evaluate the safety and tolerability of Hemay005 tablets after single and multiple oral doses in healthy Caucasian adult volunteers. The secondary objective of this study is to assess the pharmacokinetic parameters (time to remove the study drug from blood) of Hemay005 tablets after single and multiple oral doses. The results of Chinese healthy volunteers will be used as a historical control to compare the ethnic differences between Chinese and Caucasians. Approximately 12 eligible healthy (Caucasian) adult participants (male: female = 1:1) will be enrolled in this study. The participant will be screened to determine their suitability to take part in the study within 28 days before receiving a dose of the study treatment. There will be one confinement period in the clinic, which will start on the day before dosing with dosing on Day 1 and discharge on Day 11. The participant will be asked to attend the clinic for a final study visit on Day 20. This visit will be the end of the participation in this study.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
12
The eligible healthy adult participants will enter Single-dose Administration Period, receiving a single administration of Hemay005 tablets orally at a dose of 60 mg on Day 1 morning under fasted condition. On Day 3, those participants will receive Hemay005 tablets at dose of 60 mg for 7 consecutive days, which will be administrated twice daily (BID) during Day 3 to Day 8 and only in the morning on Day 9.
Scientia Clinical Research Ltd
Randwick, New South Wales, Australia
Number of participants with Adverse Events (AE) following administration of Hemay005 tablets as a measure of safety and tolerability
Incidence and severity of adverse events as assessed by CTCAE V5.0 by the investigator.
Time frame: Up to Day 20 after the first dose
Number of participants with abnormal hematology laboratory tests results following administration of Hemay005 tablets as a measure of safety and tolerability
The safety and tolerability of Hemay005 tablets will be assessed by Clinical laboratory abnormality in hematology assessed by changes from baseline following administration of Hemay005 tablets
Time frame: Up to Day 20 after the first dose
Number of participants with abnormal chemistry laboratory tests results following administration of Hemay005 tablets as a measure of safety and tolerability
The safety and tolerability of Hemay005 tablets will be assessed by Clinical laboratory abnormality in clinical chemistry assessed by changes from baseline following administration of Hemay005 tablets
Time frame: Up to Day 20 after the first dose
Number of participants with abnormal coagulation laboratory tests results following administration of Hemay005 tablets as a measure of safety and tolerability
The safety and tolerability of Hemay005 tablets will be assessed by Clinical laboratory abnormality in coagulation assessed by changes from baseline following administration of Hemay005 tablets
Time frame: Up to Day 20 after the first dose
Number of participants with abnormal urinalysis results following administration of Hemay005 tablets as a measure of safety and tolerability
The safety and tolerability of Hemay005 tablets will be assessed by Clinical laboratory abnormality in urinalysis assessed by changes from baseline following administration of Hemay005 tablets
Time frame: Up to Day 20 after the first dose
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Number of participants with abnormal stool analysis results following administration of Hemay005 tablets as a measure of safety and tolerability
The safety and tolerability of Hemay005 tablets will be assessed by Clinical laboratory abnormality in stools assessed by changes from baseline following administration of Hemay005 tablets
Time frame: Up to Day 20 after the first dose
Number of participants with abnormal systolic and diastolic blood pressure following administration of Hemay005 tablets as a measure of safety and tolerability
The safety and tolerability of Hemay005 tablets will be assessed by changes in Vital signs from baseline measuring blood pressure. Blood pressure is measured by placing the stethoscope over the arm.
Time frame: Up to Day 20 after the first dose
Number of participants with abnormal heart rate following administration of Hemay005 tablets as a measure of safety and tolerability
The safety and tolerability of Hemay005 tablets will be assessed by changes in Vital signs from baseline measuring heart rate. Heart Rate is measured by an ECG and respiration rate is counted manually as breaths per minute by the Clinical Unit Assistants.
Time frame: Up to Day 20 after the first dose
Number of participants with abnormal body temperature following administration of Hemay005 tablets as a measure of safety and tolerability
The safety and tolerability of Hemay005 tablets will be assessed by changes in Vital signs from baseline measuring body temperature. Body temperature is measured using an oral thermometer.
Time frame: Up to Day 20 after the first dose
Number of participants with abnormal electrocardiograms readings following administration of Hemay005 tablets as a measure of safety and tolerability
12-lead ECGs will be obtained during the study using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT, and QT duration corrected for heart rate by Fridericia's formula (QTcF intervals) at each timepoint
Time frame: Up to Day 20 after the first dose
Change from baseline in the maximum plasma concentration (Cmax) following administration of Hemay005 tablets to evaluate the pharmacokinetics (PK) characteristics of Hemay005 tablets
The PK parameters are assessed by measuring the maximum plasma concentration (Cmax)
Time frame: On Day 1 and Day 9, blood samples for PK analysis will be collected within 1 hour pre-dose, 0.5, 1, 1.5, 2, 3, 5, 8, 12, 16, 24, 36 and 48 hours post-dose; during Day 4 to Day 8 in the morning prior to administration.
Change from baseline in time to Cmax (Tmax) following administration of Hemay005 tablets to evaluate the pharmacokinetics (PK) characteristics of Hemay005 tablets
The PK parameters are assessed by measuring the time to Cmax (Tmax)
Time frame: On Day 1 and Day 9, blood samples for PK analysis will be collected within 1 hour pre-dose, 0.5, 1, 1.5, 2, 3, 5, 8, 12, 16, 24, 36 and 48 hours post-dose; during Day 4 to Day 8 in the morning prior to administration.
Area under the curve from time 0 to the last measurable concentration (AUC0-t) to evaluate the Pharmacokinetic (PK) parameters of Hemay005 tablets
The PK parameters are assessed by measuring the area under the curve from time 0 to the last measurable concentration (AUC0-t)
Time frame: On Day 1 and Day 9, blood samples for PK analysis will be collected within 1 hour pre-dose, 0.5, 1, 1.5, 2, 3, 5, 8, 12, 16, 24, 36 and 48 hours post-dose; during Day 4 to Day 8 in the morning prior to administration.
Area under the curve from time 0 extrapolated to infinite time (AUC0-inf) to assess the Pharmacokinetic (PK) parameters of Hemay005 tablets
The PK parameters are assessed by measuring the area under the curve from time 0 extrapolated to infinite time (AUC0-inf),
Time frame: On Day 1 and Day 9, blood samples for PK analysis will be collected within 1 hour pre-dose, 0.5, 1, 1.5, 2, 3, 5, 8, 12, 16, 24, 36 and 48 hours post-dose; during Day 4 to Day 8 in the morning prior to administration.
Change from Baseline in half-life (t1/2) following administration of Hemay005 tablets to evaluate the pharmacokinetics (PK) characteristics of Hemay005 tablets
The PK parameters are assessed by measuring the half-life (t1/2)
Time frame: On Day 1 and Day 9, blood samples for PK analysis will be collected within 1 hour pre-dose, 0.5, 1, 1.5, 2, 3, 5, 8, 12, 16, 24, 36 and 48 hours post-dose; during Day 4 to Day 8 in the morning prior to administration.
Change from Baseline in apparent clearance (CL/F) following administration of Hemay005 tablets to evaluate the pharmacokinetics (PK) characteristics of Hemay005 tablets
The PK parameters are assessed by measuring the apparent clearance (CL/F)
Time frame: On Day 1 and Day 9, blood samples for PK analysis will be collected within 1 hour pre-dose, 0.5, 1, 1.5, 2, 3, 5, 8, 12, 16, 24, 36 and 48 hours post-dose; during Day 4 to Day 8 in the morning prior to administration.
Change from Baseline in apparent volume of distribution (Vz/F) following administration of Hemay005 tablets to evaluate the pharmacokinetics (PK) characteristics of Hemay005 tablets
The PK parameters are assessed by measuring the apparent volume of distribution (Vz/F)
Time frame: On Day 1 and Day 9, blood samples for PK analysis will be collected within 1 hour pre-dose, 0.5, 1, 1.5, 2, 3, 5, 8, 12, 16, 24, 36 and 48 hours post-dose; during Day 4 to Day 8 in the morning prior to administration.
Change from Baseline in serum trough concentration (Ctrough) following administration of Hemay005 tablets to evaluate the pharmacokinetics (PK) characteristics of Hemay005 tablets
The PK parameters are assessed by measuring the serum trough concentration (Ctrough)
Time frame: On Day 1 and Day 9, blood samples for PK analysis will be collected within 1 hour pre-dose, 0.5, 1, 1.5, 2, 3, 5, 8, 12, 16, 24, 36 and 48 hours post-dose; during Day 4 to Day 8 in the morning prior to administration.
Area under the curve extrapolated as a percentage of the total (AUC_%Extrap) to assess the Pharmacokinetic (PK) parameters of Hemay005 tablets
The PK parameters are assessed by measuring the area under the curve extrapolated as a percentage of the total (AUC\_%Extrap)
Time frame: On Day 1 and Day 9, blood samples for PK analysis will be collected within 1 hour pre-dose, 0.5, 1, 1.5, 2, 3, 5, 8, 12, 16, 24, 36 and 48 hours post-dose; during Day 4 to Day 8 in the morning prior to administration.
Change from Baseline in mean residence time from the time of dosing to the time of last measurable concentration (MRTlast) to assess the Pharmacokinetic (PK) parameters of Hemay005 tablets
The PK parameters are assessed by measuring mean residence time from the time of dosing to the time of last measurable concentration (MRTlast)
Time frame: On Day 1 and Day 9, blood samples for PK analysis will be collected within 1 hour pre-dose, 0.5, 1, 1.5, 2, 3, 5, 8, 12, 16, 24, 36 and 48 hours post-dose; during Day 4 to Day 8 in the morning prior to administration.