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
Overview
- Phase
- Phase 1
- Intervention
- ZX-7101A
- Conditions
- Safety Issues
- Sponsor
- Nanjing Zenshine Pharmaceuticals
- Enrollment
- 66
- Locations
- 1
- Primary Endpoint
- Incidence and severity of adverse effect (TEAEs) and severe adverse events (SAEs)
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Arms & Interventions
Single dose of ZX-7101A treatment A
Administrated as a single oral dose in healthy subjects
Intervention: ZX-7101A
Single dose of ZX-7101A treatment A
Administrated as a single oral dose in healthy subjects
Intervention: Placebo
Single dose of ZX-7101A treatment B
Administrated as a single oral dose in healthy subjects
Intervention: ZX-7101A
Single dose of ZX-7101A treatment B
Administrated as a single oral dose in healthy subjects
Intervention: Placebo
Single dose of ZX-7101A treatment C
Administrated as a single oral dose in healthy subjects
Intervention: ZX-7101A
Single dose of ZX-7101A treatment C
Administrated as a single oral dose in healthy subjects
Intervention: Placebo
Single dose of ZX-7101A treatment D
Administrated as a single oral dose in healthy subjects
Intervention: ZX-7101A
Single dose of ZX-7101A treatment D
Administrated as a single oral dose in healthy subjects
Intervention: Placebo
Single dose of ZX-7101A treatment E
Administrated as a single oral dose in healthy subjects
Intervention: ZX-7101A
Single dose of ZX-7101A treatment E
Administrated as a single oral dose in healthy subjects
Intervention: Placebo
ZX-7101A food effect
Administered as a selected, single oral dose of ZX-7101A in fasting state and non-fasting (with food) state.
Intervention: ZX-7101A
Outcomes
Primary Outcomes
Incidence and severity of adverse effect (TEAEs) and severe adverse events (SAEs)
Time Frame: Day 1-day15
safety and tolerability
Secondary Outcomes
- Peak plama concentration of ZX-7101A(Days 1-15)
- Area under the plasma concentration of ZX-7101A(Days 1-15)
- Half-life of ZX-7101A(Days 1-15)
- Concentration of ZX-7101A in urine(Days 1-15)