Status:
COMPLETED
Study to Assess the Safety, Tolerability and Pharmacokinetics of ZX-7101A and the Food Effect in Healthy Volunteers
Lead Sponsor:
Nanjing Zenshine Pharmaceuticals
Conditions:
Safety Issues
Tolerance
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 19 2022
Estimated Enrollment :
66 Patients enrolled
Trial Details
Trial ID
NCT05217732
Start Date
December 1 2021
End Date
December 19 2022
Last Update
July 21 2023
Active Locations (1)
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1
Fudan University affiliated Huashan Hospital
Shanghai, Shanghai Municipality, China