Pharmacokinetics Clinical Trial
Official title:
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
Verified date | January 2022 |
Source | Nanjing Zenshine Pharmaceuticals |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 66 |
Est. completion date | December 19, 2022 |
Est. primary completion date | August 29, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 45 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
China | Fudan University affiliated Huashan Hospital | Shanghai | Shanghai |
Lead Sponsor | Collaborator |
---|---|
Nanjing Zenshine Pharmaceuticals |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Incidence and severity of adverse effect (TEAEs) and severe adverse events (SAEs) | safety and tolerability | Day 1-day15 | |
Secondary | Peak plama concentration of ZX-7101A | To evaluate the maximum observed concentration (Cmax) after single oral dose of ZX-7101A | Days 1-15 | |
Secondary | Area under the plasma concentration of ZX-7101A | To evaluate the area under the curve (AUC) plasma-concentration after single oral dose of ZX-7101A | Days 1-15 | |
Secondary | Half-life of ZX-7101A | To evaluate the half-life of ZX-7101A after single oral dose of ZX-7101A | Days 1-15 | |
Secondary | Concentration of ZX-7101A in urine | To evaluate the concentration at a select treatment after single oral dose of ZX-7101A | Days 1-15 |
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