Study to Assess the Safety, Tolerability and Pharmacokinetics of ZX-7101A and the Food Effect in Healthy Volunteers
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 1 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Single dose of ZX-7101A treatment A Administrated as a single oral dose in healthy subjects |
Drug: ZX-7101A
tablet
Drug: Placebo
Tablet
|
Experimental: Single dose of ZX-7101A treatment B Administrated as a single oral dose in healthy subjects |
Drug: ZX-7101A
tablet
Drug: Placebo
Tablet
|
Experimental: Single dose of ZX-7101A treatment C Administrated as a single oral dose in healthy subjects |
Drug: ZX-7101A
tablet
Drug: Placebo
Tablet
|
Experimental: Single dose of ZX-7101A treatment D Administrated as a single oral dose in healthy subjects |
Drug: ZX-7101A
tablet
Drug: Placebo
Tablet
|
Experimental: Single dose of ZX-7101A treatment E Administrated as a single oral dose in healthy subjects |
Drug: ZX-7101A
tablet
Drug: Placebo
Tablet
|
Experimental: ZX-7101A food effect Administered as a selected, single oral dose of ZX-7101A in fasting state and non-fasting (with food) state. |
Drug: ZX-7101A
tablet
|
Outcome Measures
Primary Outcome Measures
- Incidence and severity of adverse effect (TEAEs) and severe adverse events (SAEs) [Day 1-day15]
safety and tolerability
Secondary Outcome Measures
- 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
Eligibility Criteria
Criteria
Inclusion Criteria:
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Healthy adults age of 18-45 years old
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BMI in the range of 9~26 kg/m2; Bodyweight (male) ≥50kg, Bodyweight (Female) ≥45kg
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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:
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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
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Estimated glomerular filtration rate (eGFR) <90 mL/min/1.73 m2
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QTc interval > 450ms ( Fridericia's correction , QTcF=QT/(RR^0.33) ), QRS>120ms
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Acute respiratory tract infection within 2 weeks
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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
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Use of tobacco or nicotine containing products more than the equivalent of 5 cigarettes per day within 3 months
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Unwilling or unable to restrict the intake of caffeine or alcohol within 72 hours before dosing or during the in-patient observation period
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Use or intake of any known liver enzyme inducer or inhibitor within 14 days
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History of drug abuse or positive urine drug test
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Positive test for Hepatitis C antibody (HCV), Hepatitis B surface antigen (HbsAg), Human immunodeficiency virus (HIV) antibody, or Syphilis antibody at Screening
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Accumulative blood donation >400ml within 3 months or >200ml within 4 weeks or planning to donate during the study
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Pregnancy or lactating at screening
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Having difficulty of drawing blood from vein
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Treatment with an investigational drug or procedure within 3 months
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Received vaccination within 3 months or plan to be received vaccine during the study
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Received any surgical procedure within 3 months at screening
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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.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Fudan University affiliated Huashan Hospital | Shanghai | Shanghai | China |
Sponsors and Collaborators
- Nanjing Zenshine Pharmaceuticals
Investigators
- Study Director: Xiaoli Qin, PhD, Zenshine Pharmaceuticals
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ZX-7101A-201