HealthyPhase 1NCT05941247
A Study to Evaluate the Effects of Single and Multiple Doses of Hemay005 Tablets in Health Caucasian Adult Volunteers
A Phase 1 study testing Hemay005 60 mg in people with Healthy, run by Ganzhou Hemay Pharmaceutical Co., Ltd at 1 site in Australia.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Hemay005 60 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteAustralia
- Study dates
- 17 Jul 2023to 20 Aug 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adult male or female Caucasian participants (male: female = 1:1) between 18 and 55 years of age (both inclusive) at the time of signing the informed consent.
- Body weight between 50 and 100 kg (both inclusive) for males or between 45 and 100 kg (both inclusive) for females; and body mass index (BMI) within 18-32 kg/m2 (both inclusive).
- In good health as determined by screening tests. Good health is defined as having no clinically relevant abnormalities identified by a detailed medical history, full physical examination, vital signs (including measurement of body temperature, HR, blood pressure and respiratory rate), 12-lead ECG, and clinical laboratory tests.
- Female participants must not be pregnant or breastfeeding and must use an effective contraception method from informed consent obtained to 180 days after last dose administration, with the exception of participants who have undergone sterilization in the preceding 3 months, or who are postmenopausal.
- A woman of childbearing potential (WOCBP) must undergo pregnancy testing prior to the first dose of the investigational medicinal product (IMP). The participant must be excluded from the study if the serum pregnancy test is positive. A postmenopausal state is defined as 12 months of amenorrhea without an alternative medical cause. In the absence of 12 months of amenorrhea, menopause may be confirmed by follicle-stimulating hormone (FSH) measurement. Females on hormonal replacement therapy (HRT), where menopausal status is indeterminate, will be required to use a non-estrogen hormonal contraceptive method if they wish to continue their HRT during the study. Participants must otherwise discontinue HRT to allow for confirmation of postmenopausal status prior to enrollment in the study.
- Males who are sexually active and who are partners of women of childbearing potential must agree to use an effective contraception from informed consent obtained to 180 days after last dose administration.
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- A negative result on urine drug screen (amphetamines/methamphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, opiates).
- Provide written informed consent prior to undertaking any study-related procedures.
- Must not be under any administrative or legal supervision or under institutionalization as per a regulatory or juridical order.
Who cannot join
- Any history or presence of clinically relevant cardiovascular, pulmonary, gastrointestinal, hepatic, renal, metabolic, hematological, neurological, musculoskeletal, rheumatological, psychiatric, systemic, ocular, or infectious disease, or signs of acute illness.
- Any history or presence of gastrointestinal, hepatic, renal disease that affect drug absorption or metabolism.
- Any history or presence of chronic infectious diseases such as tuberculosis (TB) (judged by the Investigator according to QuantiFERON-TB Gold).
- Presence or history of drug/food hypersensitivity, or anaphylactic reaction, diagnosed and treated by a physician, or have special dietary requirements.
- Known hypersensitivity to any component of the IMP formulation.
- Any surgery within 1 months prior to the first dose.
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- Positive result on any of the following tests: hepatitis B virus (HBV), hepatitis C virus (HCV), human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), hepatitis B core antibodies (HBcAb) (for those with positive result on HbcAb, a HBV deoxyribonucleic acid (DNA) test will be performed and those with positive HBV DNA results will be excluded), HCV antibody (HCVAb), anti-human immunodeficiency virus 1 and 2 antibodies.
- History or presence of alcohol abuse (defined as alcohol consumption more than 2 units per day 6 months prior to the first dose, 1 unit=360 mL of beer or 45 mL of alcohol 40% and above or 150 mL of wine).
- History of drug abuse including narcotic and psychiatric drugs within 1 year prior to screening or a positive drug abuse test result at screening. One repeat is allowed at the discretion of the study doctor in case of false positives.
- Regular smoking (defined as more than 5 cigarettes or equivalent per week) within one year prior to the first dose, or unable to stop smoking from 48 hours prior to the first drug administration to the last time point for collecting PK blood samples (Day 11).
- Positive alcohol test at screening and check-in on Day -1.
- Any consumption of xanthine bases and/or grapefruit or products containing xanthine bases and/or grapefruit within 2 weeks prior to the first dose; or unable to stop consumption of above ingredients during the pharmacokinetic (PK) assessments period (Day 1 to Day 11).
- Any consumption of chocolate or caffeine or products containing caffeine within 48hours prior to the first dose; or unable to stop consumption of above ingredients during the PK assessments period (Day1 to Day11).
- Any consumption of alcohol or products containing alcohol within 48 hours prior to study site admission (Day -1); or unable to stop consumption of alcohol during the PK assessments period (Day 1-Day 11).
- Any drug that inhibits or induces liver drug metabolism (inducers include barbiturates, carbamazepine, rifampicin, phenytoin, glucocorticoids, omeprazole, etc.; inhibitors include selective serotonin reuptake inhibitor (SSRI) antidepressants, cimetidine, diltiazem, macrolides, nitroimidazoles, sedative-hypnotics, verapamil, fluoroquinolones, antihistamines, etc.) within 30 days prior to the first dose or during the study.
- Any prescription medication, within 14 days prior to administration of the first dose, with the exception of hormonal contraception, menopausal hormone replacement therapy or occasional analgesics such as Paracetamol, Ibuprofen and standard daily vitamins etc. in short term at the Investigator's direction.
- Made a blood donation of greater than 400 ml within 4 weeks prior to the first dose or during the study.
- Any participant who enrolled in or participated in any other clinical study involving an investigational product, or in any other type of medical research within 1 month or within 5 times the elimination t1/2 prior to administration of the first dose.
- Any vaccination in the 14 days prior to administration of the first dose.
- Any participant who, in the judgment of the Investigator, is likely to be non-compliant during the study, or to be unable to cooperate due to language problems or poor mental development.
- Any participant who is the Investigator, research assistant, pharmacist, study coordinator, or other staff thereof directly involved in conducting the study or any person dependent on (employees or immediate family members) the study site, the Investigator or the Sponsor.
- Any participant who cannot be contacted in the case of an emergency.
- Any participant in whom venous blood collection is difficult.
Trial locations and contacts
1 site in 1 country.
Australia1 site
Scientia Clinical Research Ltd
Randwick, New South Wales, 2031
About this study
Official title: A Phase I, Single-arm, Open-label, Ethnobridging Study to Evaluate the Safety, Tolerability, and Pharmacokinetics (PK) of Single and Multiple Oral Doses of Hemay005 Tablets in Healthy Caucasian Adult Volunteers
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.
Read the detailed description
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.
- Conditions
- Healthy
- Being tested
- Hemay005 60 mg
- Keywords
- PK parameters, Caucasian
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hemay005 60 mgDrug
Also called Hemay005 treatment group
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.
| Study group | Role | What they receive |
|---|---|---|
| Hemay005 60 mg | Experimental | The participant will receive single administration of Hemay005 tablets at dose of 60 mg on Day 1. Thereafter, those participants will receive Hemay005 tablets at dose of 60 mg for 7 consecutive days, which will be administrated twice daily. Receives: Drug: Hemay005 60 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Up to Day 20 after the first dose
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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: Up to Day 20 after the first dose
Secondary outcomes (10)
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)
Measured: 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)
Measured: 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)
Measured: 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),
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2023
- Study start17 Jul 2023
- Primary completion8 Aug 2023
- Study completion20 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ganzhou Hemay Pharmaceutical Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Hemay Pharmaceutical PTY. LTD.
- Responsible party
- Sponsor
- Investigators
- Christopher J Argent, Principal investigator, Scientia Clinical Research Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05941247
- Sponsor's protocol ID
- HM005PS1S05
- Status last verified
- Jul 2023
- First submitted
- 5 Apr 2023
- Last updated
- 1 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared to other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Single-arm, Open-label, Ethnobridging Study to Evaluate the Safety, Tolerability, and Pharmacokinetics (PK) of Single and Multiple Oral Doses of Hemay005 Tablets in Healthy Caucasian Adult Volunteers
- ClinicalTrials.gov ID
- NCT05941247
- Acronym / sponsor ID
- HM005PS1S05
- Conditions
- Healthy
- Keywords
- PK parameters, Caucasian
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Ganzhou Hemay Pharmaceutical Co., LtdIndustry (pharma, biotech, devices)
- Collaborators
- Hemay Pharmaceutical PTY. LTD.
- Study start
- 17 Jul 2023 (actual)
- Primary completion
- 8 Aug 2023 (actual)
- Study completion
- 20 Aug 2023 (actual)
- First posted
- 12 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hemay005 60 mg | Experimental | Drug: Hemay005 60 mgThe participant will receive single administration of Hemay005 tablets at dose of 60 mg on Day 1. Thereafter, those participants will receive Hemay005 tablets at dose of 60 mg for 7 consecutive days, which will be administrated twice daily. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Healthy adult male or female Caucasian participants (male: female = 1:1) between 18 and 55 years of age (both inclusive) at the time of signing the informed consent.
- Body weight between 50 and 100 kg (both inclusive) for males or between 45 and 100 kg (both inclusive) for females; and body mass index (BMI) within 18-32 kg/m2 (both inclusive).
- In good health as determined by screening tests. Good health is defined as having no clinically relevant abnormalities identified by a detailed medical history, full physical examination, vital signs (including measurement of body temperature, HR, blood pressure and respiratory rate), 12-lead ECG, and clinical laboratory tests.
- Female participants must not be pregnant or breastfeeding and must use an effective contraception method from informed consent obtained to 180 days after last dose administration, with the exception of participants who have undergone sterilization in the preceding 3 months, or who are postmenopausal.
- A woman of childbearing potential (WOCBP) must undergo pregnancy testing prior to the first dose of the investigational medicinal product (IMP). The participant must be excluded from the study if the serum pregnancy test is positive. A postmenopausal state is defined as 12 months of amenorrhea without an alternative medical cause. In the absence of 12 months of amenorrhea, menopause may be confirmed by follicle-stimulating hormone (FSH) measurement. Females on hormonal replacement therapy (HRT), where menopausal status is indeterminate, will be required to use a non-estrogen hormonal contraceptive method if they wish to continue their HRT during the study. Participants must otherwise discontinue HRT to allow for confirmation of postmenopausal status prior to enrollment in the study.
Key exclusion criteria (23 listed)
- Any history or presence of clinically relevant cardiovascular, pulmonary, gastrointestinal, hepatic, renal, metabolic, hematological, neurological, musculoskeletal, rheumatological, psychiatric, systemic, ocular, or infectious disease, or signs of acute illness.
- Any history or presence of gastrointestinal, hepatic, renal disease that affect drug absorption or metabolism.
- Any history or presence of chronic infectious diseases such as tuberculosis (TB) (judged by the Investigator according to QuantiFERON-TB Gold).
- Presence or history of drug/food hypersensitivity, or anaphylactic reaction, diagnosed and treated by a physician, or have special dietary requirements.
- Known hypersensitivity to any component of the IMP formulation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hemay005 60 mgAlso: Hemay005 treatment groupThe 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. | Drug | Hemay005 60 mg |
Primary outcome
Number of participants with Adverse Events (AE) following administration of Hemay005 tablets as a measure of safety and tolerability
Time frame: Up to Day 20 after the first dose
Incidence and severity of adverse events as assessed by CTCAE V5.0 by the investigator.
Number of participants with abnormal hematology laboratory tests results following administration of Hemay005 tablets as a measure of safety and tolerability
Time frame: Up to Day 20 after the first dose
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
Number of participants with abnormal chemistry laboratory tests results following administration of Hemay005 tablets as a measure of safety and tolerability
Time frame: Up to Day 20 after the first dose
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
Number of participants with abnormal coagulation laboratory tests results following administration of Hemay005 tablets as a measure of safety and tolerability
Time frame: Up to Day 20 after the first dose
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
Number of participants with abnormal urinalysis results following administration of Hemay005 tablets as a measure of safety and tolerability
Time frame: Up to Day 20 after the first dose
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
Number of participants with abnormal stool analysis results following administration of Hemay005 tablets as a measure of safety and tolerability
Time frame: Up to Day 20 after the first dose
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
Number of participants with abnormal systolic and diastolic blood pressure following administration of Hemay005 tablets as a measure of safety and tolerability
Time frame: Up to Day 20 after the first dose
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.
Number of participants with abnormal heart rate following administration of Hemay005 tablets as a measure of safety and tolerability
Time frame: Up to Day 20 after the first dose
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.
Number of participants with abnormal body temperature following administration of Hemay005 tablets as a measure of safety and tolerability
Time frame: Up to Day 20 after the first dose
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.
Number of participants with abnormal electrocardiograms readings following administration of Hemay005 tablets as a measure of safety and tolerability
Time frame: Up to Day 20 after the first dose
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
10 secondary outcomes
Change from baseline in the maximum plasma concentration (Cmax) following administration of Hemay005 tablets to evaluate the pharmacokinetics (PK) characteristics of Hemay005 tablets
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
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
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
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
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
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
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
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
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
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2024.
- Individual participant dataSharing planned: No. IPD will not be shared to other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christopher J Argent principal investigator
Scientia Clinical Research Ltd
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Hemay005 60 mg in people with Healthy, run by Ganzhou Hemay Pharmaceutical Co., Ltd at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with Adverse Events (AE) following administration of Hemay005 tablets as a measure of safety and tolerability (time frame: Up to Day 20 after the first dose). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2024.