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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05217732
Other study ID # ZX-7101A-201
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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