To Evaluate the Safety, Tolerability, Pharmacokinetics and the Effect of Food on the Hemay5259 Sustained-release Tablets in Healthy Subjects.

NCT07703904 | Not Yet Recruiting Phase 1

• 1 other identifier: HM5259HV1S01
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

Evaluation of the pharmacokinetics of Hemay 5259 sustained-release tablets in healthy human subjects

Conditions

Pharmacokinetics

Outcome Measures

Primary Outcomes (8)

• Pharmacokinetics (PK) of Hemay5259: Maximum plasma concentration (Cmax)in Part 1 and Part 2

  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

  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

  Day1-Day4，Day10-Day22

• Pharmacokinetics (PK) of Hemay5259:time to Cmax (Tmax) in single dose and Multiple dose

  Day1-Day4，Day10-Day22

• Pharmacokinetics (PK) of Hemay5259:time to half-life (t1/2)in single dose and Multiple dose

  Day1-Day4，Day10-Day22

• PK of Hemay5259: Observed Apparent volume of distribution (Vz/F) in singel dose and multiple dose:

  Day1-Day4，Day10-Day22

• PK of Hemay5259: Observed Accumulation ratio calculated from AUC (Rac(AUC)) in multiple dose

  D13-D22

• PK of Hemay5259: Observed Accumulation ratio calculated from Cmax (Rac(Cmax)) in multiple dose

  Day13-Day22

Secondary Outcomes (1)

• Adverse events assessments after single and multiple ascending dose administration at baseline and repeatedly until study completion

  through study completion, an average of 1 month

Study Arms (4)

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

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.

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

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.

Drug: Placebo group 2

Interventions

Hemay5259 group 1 DRUG

Food influence test: single administration of the drug, multiple dosing trial: administration once daily

Hemay5259 group 1

placebo group 1 DRUG

Food effect trial: single administration of the drug, multiple dosing trial: administration once daily

Placebo group 1

Hemay5259 group 2 DRUG

Food influence test: single administration of the drug, multiple dosing test: administration once daily

Hemay5259 group 2

Placebo group 2 DRUG

Food influence test: single administration of the drug, multiple dosing test: administration once daily

Placebo group 2

Eligibility Criteria

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

You may qualify if:

• 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);
• 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.

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 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.

Sponsors & Collaborators

• Hemay Pharmaceutical PTY. LTD.: lead

Study Sites (1)

Scientia Clinical Research Ltd

Randwick, New South Wales, Australia

Location

Central Study Contacts

Zimeng Wang

CONTACT

022-24929667; wangzimeng@hemay.com.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 18, 2026
• First Posted: July 15, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): October 31, 2026
• Last Updated: July 15, 2026

Record last verified: 2026-07

Locations

AU (1)