Food Effect, Pharmacokinetics, Safety Issues, Tolerance
Conditions
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.
Interventions
DRUGPlacebo
Tablet
DRUGZX-7101A
tablet
Sponsors
Nanjing Zenshine Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
double-blind, placebo-controled study
Intervention model description
single ascending doses in part 1 and fasting/nonfasting crossover in part 2
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence and severity of adverse effect (TEAEs) and severe adverse events (SAEs) | Day 1-day15 | safety and tolerability |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Half-life of ZX-7101A | Days 1-15 | To evaluate the half-life of ZX-7101A after single oral dose of ZX-7101A |
| Concentration of ZX-7101A in urine | Days 1-15 | To evaluate the concentration at a select treatment after single oral dose of ZX-7101A |
Countries
China
Outcome results
None listed