Study to Assess the Safety, Tolerability and Pharmacokinetics of ZX-7101A and the Food Effect in Healthy Volunteers

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05217732
• Other study ID #: ZX-7101A-201
• Status: Completed
• Phase: Phase 1
• Start date: December 1, 2021
• Est. completion date: December 19, 2022

Study information

• Verified date: January 2022
• Source: Nanjing Zenshine Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Food Effect
• Pharmacokinetics
• Safety Issues
• Tolerance

Intervention

Drug:
• ZX-7101A
tablet
• Placebo
Tablet

Locations

Country	Name	City	State
China	Fudan University affiliated Huashan Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Nanjing Zenshine Pharmaceuticals

Country where clinical trial is conducted

China, 

Outcome

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