Study to Assess the Safety, Tolerability and Pharmacokinetics of ZX-7101A and the Food Effect in Healthy Volunteers
Phase 1
Completed
- Conditions
- Safety IssuesTolerancePharmacokineticsFood Effect
- Interventions
- Drug: Placebo
- Registration Number
- NCT05217732
- Lead Sponsor
- Nanjing Zenshine Pharmaceuticals
- Brief Summary
Randomized, double-blind and placebo-controled study to assess the safety, tolerability and pharmacokinetics of single ascending doses of ZX-7101A and its food effect in China healthy adult volunteers. The study is composed of 2 parts. Part 1 is to assess the safety, tolerability and pharmacokinetics of a single ascending doses of ZX-7101A tablet. Part 2 is to assess the food effect on ZX-7101A at a selected dose in a cross-over design.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 66
Inclusion Criteria
- Healthy adults age of 18-45 years old
- BMI in the range of 9~26 kg/m2; Bodyweight (male) ≥50kg, Bodyweight (Female) ≥45kg
- In the judgement of the investigator, no clinically relevant abnormalities identified by a detailed medical history and full physical examination including BP and pulse rate measurement, or clinical laboratory tests
- Female subjects of nonchildbearing potential must be not pregnant or lactating. Subjects must consent and comply with the contraception requirement of the study.
- Able to understand the risks involved in the study, and provide written informed consent before the first study-specific procedure
- Able to understand and comply with the study procedures
Exclusion Criteria
- History of hypersensitivity or allergy to drug or food
- History of clinically significant abnormalities such as metabolic, liver, kidney, blood, lung, cardiovascular, gastrointestinal, urinary, endocrine, neurological, or psychiatric disorders; or in the judgement of the investigator, any medical abnormality that may be a concern to participate the study.
- Tympanic temperature >37.5℃, Pulse >100bmp or <50bmp, Systolic blood pressure ≥140mHg or ≤90mHg, or Diastolic blood pressure ≥90mHg or<50mHg
- Clinically relevant out-of-range baseline of total white cells or absolute neutrophil count
- Total bilirubin >1.5x ULN, AST >1.5 ULN or ALT >1.5ULN
- Estimated glomerular filtration rate (eGFR) <90 mL/min/1.73 m2
- QTc interval > 450ms （ Fridericia's correction ， QTcF=QT/(RR^0.33) ）, QRS>120ms
- Acute respiratory tract infection within 2 weeks
- Any condition possibly affecting drug absorption, e.g. gastrectomy
- Received treatment of any prescription drug or alternative medicine within 4 weeks before first dosing or any nonprescription drug within 2 weeks or 5x half-life, whichever is longer
- Regular alcohol consumption >14units/week I the past 6 months or positive in alcohol breath test
- Use of tobacco or nicotine containing products more than the equivalent of 5 cigarettes per day within 3 months
- Unwilling or unable to restrict the intake of caffeine or alcohol within 72 hours before dosing or during the in-patient observation period
- Use or intake of any known liver enzyme inducer or inhibitor within 14 days
- History of drug abuse or positive urine drug test
- Positive test for Hepatitis C antibody (HCV), Hepatitis B surface antigen (HbsAg), Human immunodeficiency virus (HIV) antibody, or Syphilis antibody at Screening
- Accumulative blood donation >400ml within 3 months or >200ml within 4 weeks or planning to donate during the study
- Pregnancy or lactating at screening
- Having difficulty of drawing blood from vein
- Treatment with an investigational drug or procedure within 3 months
- Received vaccination within 3 months or plan to be received vaccine during the study
- Received any surgical procedure within 3 months at screening
- Any other reason that, in the opinion of the investigator, unlikely to comply with the clinical study protocol or is unsuitable for any other reason.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Single dose of ZX-7101A treatment A ZX-7101A Administrated as a single oral dose in healthy subjects Single dose of ZX-7101A treatment B Placebo Administrated as a single oral dose in healthy subjects Single dose of ZX-7101A treatment C ZX-7101A Administrated as a single oral dose in healthy subjects Single dose of ZX-7101A treatment E ZX-7101A Administrated as a single oral dose in healthy subjects Single dose of ZX-7101A treatment A Placebo Administrated as a single oral dose in healthy subjects Single dose of ZX-7101A treatment B ZX-7101A Administrated as a single oral dose in healthy subjects Single dose of ZX-7101A treatment C Placebo Administrated as a single oral dose in healthy subjects Single dose of ZX-7101A treatment D ZX-7101A Administrated as a single oral dose in healthy subjects Single dose of ZX-7101A treatment D Placebo Administrated as a single oral dose in healthy subjects Single dose of ZX-7101A treatment E Placebo Administrated as a single oral dose in healthy subjects ZX-7101A food effect ZX-7101A Administered as a selected, single oral dose of ZX-7101A in fasting state and non-fasting (with food) state.
- Primary Outcome Measures
Name Time Method Incidence and severity of adverse effect (TEAEs) and severe adverse events (SAEs) Day 1-day15 safety and tolerability
- Secondary Outcome Measures
Name Time Method Concentration of ZX-7101A in urine Days 1-15 To evaluate the concentration at a select treatment after single oral dose of ZX-7101A
Half-life of ZX-7101A Days 1-15 To evaluate the half-life of ZX-7101A after single oral dose of ZX-7101A
Peak plama concentration of ZX-7101A Days 1-15 To evaluate the maximum observed concentration (Cmax) after single oral dose of ZX-7101A
Area under the plasma concentration of ZX-7101A Days 1-15 To evaluate the area under the curve (AUC) plasma-concentration after single oral dose of ZX-7101A
Trial Locations
- Locations (1)
Fudan University affiliated Huashan Hospital
🇨🇳Shanghai, Shanghai, China