A Study to Evaluate the Effects of Single and Multiple Doses of Hemay005 Tablets in Health Caucasian Adult Volunteers

NCT05941247 | Completed Phase 1

• 1 other identifier: HM005PS1S05
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

PK parameters; Caucasian

Outcome Measures

Primary Outcomes (10)

• 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.

  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

  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

  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

  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

  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

  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.

  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.

  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.

  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

  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

  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

  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

  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

  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

  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.

Study Arms (1)

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.

Drug: Hemay005 60 mg

Interventions

Hemay005 60 mg DRUG

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.

Also known as: Hemay005 treatment group

Hemay005 60 mg

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Ganzhou Hemay Pharmaceutical Co., Ltd: lead
• Hemay Pharmaceutical PTY. LTD.: collaborator

Study Sites (1)

Scientia Clinical Research Ltd

Randwick, New South Wales, 2031, Australia

Location

MeSH Terms

Interventions

Hemay005

Study Officials

• Christopher J Argent

  Scientia Clinical Research Ltd

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 5, 2023
• First Posted: July 12, 2023
• Study Start: July 17, 2023
• Primary Completion: August 8, 2023
• Study Completion: August 20, 2023
• Last Updated: March 1, 2024

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)