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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05941247




Registration number
NCT05941247
Ethics application status
Date submitted
5/04/2023
Date registered
12/07/2023
Date last updated
1/03/2024

Titles & IDs
Public title
A Study to Evaluate the Effects of Single and Multiple Doses of Hemay005 Tablets in Health Caucasian Adult Volunteers
Scientific 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
Secondary ID [1] 0 0
HM005PS1S05
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Healthy 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Hemay005 60 mg

Experimental: Hemay005 60 mg - 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.


Treatment: Drugs: Hemay005 60 mg
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.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of participants with Adverse Events (AE) following administration of Hemay005 tablets as a measure of safety and tolerability
Timepoint [1] 0 0
Up to Day 20 after the first dose
Primary outcome [2] 0 0
Number of participants with abnormal hematology laboratory tests results following administration of Hemay005 tablets as a measure of safety and tolerability
Timepoint [2] 0 0
Up to Day 20 after the first dose
Primary outcome [3] 0 0
Number of participants with abnormal chemistry laboratory tests results following administration of Hemay005 tablets as a measure of safety and tolerability
Timepoint [3] 0 0
Up to Day 20 after the first dose
Primary outcome [4] 0 0
Number of participants with abnormal coagulation laboratory tests results following administration of Hemay005 tablets as a measure of safety and tolerability
Timepoint [4] 0 0
Up to Day 20 after the first dose
Primary outcome [5] 0 0
Number of participants with abnormal urinalysis results following administration of Hemay005 tablets as a measure of safety and tolerability
Timepoint [5] 0 0
Up to Day 20 after the first dose
Primary outcome [6] 0 0
Number of participants with abnormal stool analysis results following administration of Hemay005 tablets as a measure of safety and tolerability
Timepoint [6] 0 0
Up to Day 20 after the first dose
Primary outcome [7] 0 0
Number of participants with abnormal systolic and diastolic blood pressure following administration of Hemay005 tablets as a measure of safety and tolerability
Timepoint [7] 0 0
Up to Day 20 after the first dose
Primary outcome [8] 0 0
Number of participants with abnormal heart rate following administration of Hemay005 tablets as a measure of safety and tolerability
Timepoint [8] 0 0
Up to Day 20 after the first dose
Primary outcome [9] 0 0
Number of participants with abnormal body temperature following administration of Hemay005 tablets as a measure of safety and tolerability
Timepoint [9] 0 0
Up to Day 20 after the first dose
Primary outcome [10] 0 0
Number of participants with abnormal electrocardiograms readings following administration of Hemay005 tablets as a measure of safety and tolerability
Timepoint [10] 0 0
Up to Day 20 after the first dose
Secondary outcome [1] 0 0
Change from baseline in the maximum plasma concentration (Cmax) following administration of Hemay005 tablets to evaluate the pharmacokinetics (PK) characteristics of Hemay005 tablets
Timepoint [1] 0 0
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.
Secondary outcome [2] 0 0
Change from baseline in time to Cmax (Tmax) following administration of Hemay005 tablets to evaluate the pharmacokinetics (PK) characteristics of Hemay005 tablets
Timepoint [2] 0 0
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.
Secondary outcome [3] 0 0
Area under the curve from time 0 to the last measurable concentration (AUC0-t) to evaluate the Pharmacokinetic (PK) parameters of Hemay005 tablets
Timepoint [3] 0 0
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.
Secondary outcome [4] 0 0
Area under the curve from time 0 extrapolated to infinite time (AUC0-inf) to assess the Pharmacokinetic (PK) parameters of Hemay005 tablets
Timepoint [4] 0 0
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.
Secondary outcome [5] 0 0
Change from Baseline in half-life (t1/2) following administration of Hemay005 tablets to evaluate the pharmacokinetics (PK) characteristics of Hemay005 tablets
Timepoint [5] 0 0
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.
Secondary outcome [6] 0 0
Change from Baseline in apparent clearance (CL/F) following administration of Hemay005 tablets to evaluate the pharmacokinetics (PK) characteristics of Hemay005 tablets
Timepoint [6] 0 0
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.
Secondary outcome [7] 0 0
Change from Baseline in apparent volume of distribution (Vz/F) following administration of Hemay005 tablets to evaluate the pharmacokinetics (PK) characteristics of Hemay005 tablets
Timepoint [7] 0 0
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.
Secondary outcome [8] 0 0
Change from Baseline in serum trough concentration (Ctrough) following administration of Hemay005 tablets to evaluate the pharmacokinetics (PK) characteristics of Hemay005 tablets
Timepoint [8] 0 0
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.
Secondary outcome [9] 0 0
Area under the curve extrapolated as a percentage of the total (AUC_%Extrap) to assess the Pharmacokinetic (PK) parameters of Hemay005 tablets
Timepoint [9] 0 0
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.
Secondary outcome [10] 0 0
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
Timepoint [10] 0 0
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.

Eligibility
Key inclusion criteria
1. 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.

2. 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).

3. 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.

4. 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.

5. A negative result on urine drug screen (amphetamines/methamphetamines, barbiturates,
benzodiazepines, cannabinoids, cocaine, opiates).

6. Provide written informed consent prior to undertaking any study-related procedures.

7. Must not be under any administrative or legal supervision or under
institutionalization as per a regulatory or juridical order.
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. 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.

2. Any history or presence of gastrointestinal, hepatic, renal disease that affect drug
absorption or metabolism.

3. Any history or presence of chronic infectious diseases such as tuberculosis (TB)
(judged by the Investigator according to QuantiFERON-TB Gold).

4. Presence or history of drug/food hypersensitivity, or anaphylactic reaction, diagnosed
and treated by a physician, or have special dietary requirements.

5. Known hypersensitivity to any component of the IMP formulation.

6. Any surgery within 1 months prior to the first dose.

7. 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.

8. 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).

9. 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.

10. 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).

11. Positive alcohol test at screening and check-in on Day -1.

12. 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).

13. 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).

14. 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).

15. 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.

16. 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.

17. Made a blood donation of greater than 400 ml within 4 weeks prior to the first dose or
during the study.

18. 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.

19. Any vaccination in the 14 days prior to administration of the first dose.

20. 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.

21. 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.

22. Any participant who cannot be contacted in the case of an emergency.

23. Any participant in whom venous blood collection is difficult.

Study design
Purpose of the study
Basic Science
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
17/07/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
20/08/2023
Sample size
Target
Accrual to date
Final
12
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Scientia Clinical Research Ltd - Randwick
Recruitment postcode(s) [1] 0 0
2031 - Randwick

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Ganzhou Hemay Pharmaceutical Co., Ltd
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Hemay Pharmaceutical PTY. LTD.
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief 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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT05941247
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Christopher J Argent
Address 0 0
Scientia Clinical Research Ltd
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries