PharmacokineticsPhase 1NCT07703904
To Evaluate the Safety, Tolerability, Pharmacokinetics and the Effect of Food on the Hemay5259 Sustained-release Tablets in Healthy Subjects.
A Phase 1 study testing Hemay5259 group 1 and Hemay5259 group 2 in people with Pharmacokinetics, run by Hemay Pharmaceutical PTY. LTD. at 1 site in Australia.
Trial summary
Evaluation of the pharmacokinetics of Hemay 5259 sustained-release tablets in healthy human subjects Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Pharmacokinetics
- What is being tested?
- Hemay5259 group 1 and Hemay5259 group 2
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteAustralia
- Study dates
- 1 Jul 2026to 31 Oct 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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
- Must have given written informed consent before any study-related activities are carried out and must be able to understand the full nature and purpose of the study, including possible risks and adverse effects.
- Adult males and females between ≥ 18 and ≤ 55 years (inclusive) at Screening.
- Body mass index (BMI) ≥ 18.0 and ≤ 30.0 kg/m2 with a body weight ≥ 50 kg (males) or ≥45 kg (females) at Screening.
- Participants with normal results or non-clinically significant (NCS) abnormal results in the opinion of the PI or delegate for a comprehensive examination, including physical examination, vital signs examination, laboratory tests (hematology, biochemistry, coagulation and urinalysis).
- a)Female participants are eligible to participate if they are not pregnant, not breastfeeding, and at least 1 of the following conditions applies:
- Women of non-childbearing potential (WONCBP), defined as surgically sterile (hysterectomy, bilateral salpingectomy, or bilateral oophorectomy - verbal confirmation through medical history review acceptable) or postmenopausal (no menses for 12 months and confirmed by follicle stimulating hormone [FSH] level >40 mIU/mL);
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- Woman of childbearing potential (WOCBP) and agree to practice true abstinence or agrees to use an highly effective method of contraception (refer to Section 4.6.3) consistently from the signing of informed consent form (ICF) to 90 days after the last dose of IPs and refrain from donating eggs during this period. And WOCBP must have a negative serum pregnancy test at screening and a negative urine pregnancy test at Day -1.
- Participant is in an exclusively same-sex relationship. b)Male participants must agree to practice true abstinence; be surgically sterilized (performed at least 6 months prior to screening and documented to no longer produce sperm - verbal confirmation through medical history review acceptable); or agree to use a condom plus effective contraception methods (refer to Section 4.6.3) for their female partner, if of childbearing potential, from the signing of ICF to 90 days after the last dose of IPs and refrain from donating sperm during this period. These contraception requirements do not apply if the male participant is in an exclusively same sex relationship.
- Able and willing to attend the necessary visits to the study site. Exclusion Criteria：
- 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 depression.
- Any history or presence of gastrointestinal, hepatic, renal disease that affect drug absorption or metabolism.
- Any surgery within 1 months prior to the first dose.
- Any history or presence of chronic infectious diseases such as tuberculosis (judged by the Investigator according to QuantiFERON gold).
- Participants with a clinically significant infection history within 4 weeks prior to first dose, or any serious infection requiring intravenous antimicrobial therapy within 6 months prior to Screening.
- Alkaline phosphatase (ALP), aspartate aminotransferase (AST), and alanine aminotransferase (ALT) >1.5 × upper limit of normal (ULN) at Screening or Day -1.
- Participants with clinically significant abnormal 12-lead electrocardiogram (ECG) results as judged by the PI or delegate or with a corrected QTc (formula: QTcF = QT/RR1/3) interval greater than 450 msec in males and 470 msec in females.
- Participants with positive test results for hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab), treponema pallidum antibody (Syphilis TP Ab) or human immunodeficiency virus antibody (HIV Ab) at Screening.
- Participants with estimated glomerular filtration rate (eGFR) < 90 mL/min/1.73m2 (using the CKD-EPI equation).
- 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 IP formulation.
- Participants who regularly drink more than 14 standard units of alcohol per week for females and more than 21 standard units of alcohol per week for males; 1 standard unit contains 10 g of alcohol, such as 285 mL of beer, 30 mL of 40% spirits or 100 mL of wine within 6 months prior to Screening.
- Participants with a history of drug abuse or a positive drug abuse screening test.
- 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.
- Positive alcohol test at screening and check-in on D-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 from first drug administration to the last time point for collecting PK blood samples.
- Any consumption of chocolate or caffeine or products containing caffeine within 48 h prior to the first dose; or unable to stop consumption of above ingredients from first drug administration to the last time point for collecting PK blood samples.
- Any consumption of alcohol or products containing alcohol within 48 h prior to Day-1; or unable to stop consumption of alcohol first drug administration to the last time point for collecting PK blood samples.
- 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 or within 5 times the elimination t1/2 of the medication, 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 > 400 ml within 4 weeks prior to the first dose or during the study or planning to donate blood during the study and follow up period.
- Any participant who enrolled in or participated in any other clinical study involving an IP, 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 in whom venous blood collection is difficult.
- 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 or any subinvestigator, 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Australia1 site
Scientia Clinical Research Ltd
Randwick, New South Wales
Christopher Argent, Dr, 02938255800, christopher.argent@scientiaclinicalresearch.com.au
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Single and Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Food Effect of Hemay5259 Extended-Release Tablet in Healthy Participants
Evaluation of the pharmacokinetics of Hemay 5259 sustained-release tablets in healthy human subjects
- Conditions
- Pharmacokinetics
- Being tested
- Hemay5259 group 1, placebo group 1, Hemay5259 group 2, Placebo group 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hemay5259 group 1Drug
Food influence test: single administration of the drug, multiple dosing trial: administration once daily
placebo group 1Drug
Food effect trial: single administration of the drug, multiple dosing trial: administration once daily
Hemay5259 group 2Drug
Food influence test: single administration of the drug, multiple dosing test: administration once daily
Placebo group 2Drug
Food influence test: single administration of the drug, multiple dosing test: administration once daily
| Study group | Role | What they receive |
|---|---|---|
| Hemay5259 group 1 | Experimental | Part1: Food effect group Hemay005 extended-release will be taken orally in single dose with a high-fat, high-calorie meal or at overnight fasting. Part 2: Multiple doses group Hemay005 extended-release will be taken orally once daily in 120mg Receives: Drug: Hemay5259 group 1 |
| Placebo group 1 | Placebo comparator | Part1: Food effect group Hemay005 extended-release will be taken orally in single dose with a high-fat, high-calorie meal or at overnight fasting. Part 2: Multiple doses group Hemay005 extended-release will be taken orally once daily. Receives: Drug: placebo group 1 |
| Hemay5259 group 2 | Experimental | Part1: Food effect group Hemay005 extended-release will be taken orally in single dose with a high-fat, high-calorie meal or at overnight fasting. Part 2: Multiple doses group Hemay005 extended-release will be taken orally once daily in 150mg Receives: Drug: Hemay5259 group 2 |
| Placebo group 2 | Placebo comparator | Part1: Food effect group Hemay005 extended-release will be taken orally in single dose with a high-fat, high-calorie meal or at overnight fasting. Part 2: Multiple doses group Hemay005 extended-release will be taken orally once daily. Receives: Drug: Placebo group 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics (PK) of Hemay5259: Maximum plasma concentration (Cmax)in Part 1 and Part 2
Measured: Day1-Day4，Day10-Day22
Pharmacokinetics (PK) of Hemay5259: Area under the curve from time 0 to the last measurable concentration (AUC0-last) in single dose and Multiple dose
Measured: Day1-Day4，Day10-Day22
Pharmacokinetics (PK) of Hemay5259: Area under the curve from time 0 extrapolated to infinite time (AUC0-inf)single dose and Multiple dose
Measured: Day1-Day4，Day10-Day22
Pharmacokinetics (PK) of Hemay5259:time to Cmax (Tmax) in single dose and Multiple dose
Measured: Day1-Day4，Day10-Day22
Pharmacokinetics (PK) of Hemay5259:time to half-life (t1/2)in single dose and Multiple dose
Measured: Day1-Day4，Day10-Day22
PK of Hemay5259: Observed Apparent volume of distribution (Vz/F) in singel dose and multiple dose:
Measured: Day1-Day4，Day10-Day22
PK of Hemay5259: Observed Accumulation ratio calculated from AUC (Rac(AUC)) in multiple dose
Measured: D13-D22
PK of Hemay5259: Observed Accumulation ratio calculated from Cmax (Rac(Cmax)) in multiple dose
Measured: Day13-Day22
Secondary outcomes (1)
Adverse events assessments after single and multiple ascending dose administration at baseline and repeatedly until study completion
This safety outcome combines the measure of the number of subjects experiencing adverse events (AEs), the nature and severity of those AEs and their relationship to the study treatments.
Measured: through study completion, an average of 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2026
- Study start1 Jul 2026 (estimated)
- Primary completion31 Aug 2026 (estimated)
- Study completion31 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PharmacokineticsStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hemay Pharmaceutical PTY. LTD.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07703904
- Sponsor's protocol ID
- HM5259HV1S01
- Status last verified
- Jul 2026
- First submitted
- 18 Jun 2026
- Last updated
- 15 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Single and Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Food Effect of Hemay5259 Extended-Release Tablet in Healthy Participants
- ClinicalTrials.gov ID
- NCT07703904
- Acronym / sponsor ID
- HM5259HV1S01
- Conditions
- Pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Hemay Pharmaceutical PTY. LTD.Industry (pharma, biotech, devices)
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- 31 Aug 2026 (estimated)
- Study completion
- 31 Oct 2026 (estimated)
- First posted
- 15 Jul 2026 (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.
Evaluation of the pharmacokinetics of Hemay 5259 sustained-release tablets in healthy human subjects
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Hemay5259 group 1 | Experimental | Drug: Hemay5259 group 1Part1: Food effect group Hemay005 extended-release will be taken orally in single dose with a high-fat, high-calorie meal or at overnight fasting. Part 2: Multiple doses group Hemay005 extended-release will be taken orally once daily in 120mg |
| Placebo group 1 | Placebo comparator | Drug: placebo group 1Part1: Food effect group Hemay005 extended-release will be taken orally in single dose with a high-fat, high-calorie meal or at overnight fasting. Part 2: Multiple doses group Hemay005 extended-release will be taken orally once daily. |
| Hemay5259 group 2 | Experimental | Drug: Hemay5259 group 2Part1: Food effect group Hemay005 extended-release will be taken orally in single dose with a high-fat, high-calorie meal or at overnight fasting. Part 2: Multiple doses group Hemay005 extended-release will be taken orally once daily in 150mg |
| Placebo group 2 | Placebo comparator | Drug: Placebo group 2Part1: Food effect group Hemay005 extended-release will be taken orally in single dose with a high-fat, high-calorie meal or at overnight fasting. Part 2: Multiple doses group Hemay005 extended-release will be taken orally once daily. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (36 listed)
- Must have given written informed consent before any study-related activities are carried out and must be able to understand the full nature and purpose of the study, including possible risks and adverse effects.
- Adult males and females between ≥ 18 and ≤ 55 years (inclusive) at Screening.
- Body mass index (BMI) ≥ 18.0 and ≤ 30.0 kg/m2 with a body weight ≥ 50 kg (males) or ≥45 kg (females) at Screening.
- Participants with normal results or non-clinically significant (NCS) abnormal results in the opinion of the PI or delegate for a comprehensive examination, including physical examination, vital signs examination, laboratory tests (hematology, biochemistry, coagulation and urinalysis).
- a)Female participants are eligible to participate if they are not pregnant, not breastfeeding, and at least 1 of the following conditions applies:
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Hemay5259 group 1Food influence test: single administration of the drug, multiple dosing trial: administration once daily | Drug | Hemay5259 group 1 |
| placebo group 1Food effect trial: single administration of the drug, multiple dosing trial: administration once daily | Drug | Placebo group 1 |
| Hemay5259 group 2Food influence test: single administration of the drug, multiple dosing test: administration once daily | Drug | Hemay5259 group 2 |
| Placebo group 2Food influence test: single administration of the drug, multiple dosing test: administration once daily | Drug | Placebo group 2 |
Primary outcome
Pharmacokinetics (PK) of Hemay5259: Maximum plasma concentration (Cmax)in Part 1 and Part 2
Time frame: Day1-Day4，Day10-Day22
Pharmacokinetics (PK) of Hemay5259: Area under the curve from time 0 to the last measurable concentration (AUC0-last) in single dose and Multiple dose
Time frame: Day1-Day4，Day10-Day22
Pharmacokinetics (PK) of Hemay5259: Area under the curve from time 0 extrapolated to infinite time (AUC0-inf)single dose and Multiple dose
Time frame: Day1-Day4，Day10-Day22
Pharmacokinetics (PK) of Hemay5259:time to Cmax (Tmax) in single dose and Multiple dose
Time frame: Day1-Day4，Day10-Day22
Pharmacokinetics (PK) of Hemay5259:time to half-life (t1/2)in single dose and Multiple dose
Time frame: Day1-Day4，Day10-Day22
PK of Hemay5259: Observed Apparent volume of distribution (Vz/F) in singel dose and multiple dose:
Time frame: Day1-Day4，Day10-Day22
PK of Hemay5259: Observed Accumulation ratio calculated from AUC (Rac(AUC)) in multiple dose
Time frame: D13-D22
PK of Hemay5259: Observed Accumulation ratio calculated from Cmax (Rac(Cmax)) in multiple dose
Time frame: Day13-Day22
1 secondary outcome
Adverse events assessments after single and multiple ascending dose administration at baseline and repeatedly until study completion
Time frame: through study completion, an average of 1 month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2026.
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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.
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 Hemay5259 group 1 and Hemay5259 group 2 in people with Pharmacokinetics, run by Hemay Pharmaceutical PTY. 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 36 inclusion and 0 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: opening soon, as of the sponsor's last update on 15 Jul 2026. 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zimeng Wang (022-24929667, wangzimeng@hemay.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacokinetics (PK) of Hemay5259: Maximum plasma concentration (Cmax)in Part 1 and Part 2 (time frame: Day1-Day4，Day10-Day22). The study lists 8 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 15 Jul 2026.