Clinical trial NCT05217732: Study to Assess the Safety, Tolerability and Pharmacokinetics of ZX-7101A and the Food Effect in Healthy Volunteers
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Safety Issues
Tolerance
Pharmacokinetics
Food Effect
Lead sponsor: Nanjing Zenshine Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2022-02-01
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: single ascending doses in part 1 and fasting/nonfasting crossover in part 2
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Incidence and severity of adverse effect (TEAEs) and severe adverse events (SAEs)
timeFrame: Day 1-day15
Secondary outcomes:
measure: Peak plama concentration of ZX-7101A
timeFrame: Days 1-15
measure: Area under the plasma concentration of ZX-7101A
timeFrame: Days 1-15
measure: Half-life of ZX-7101A
timeFrame: Days 1-15
measure: Concentration of ZX-7101A in urine
timeFrame: Days 1-15
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Fudan University affiliated Huashan Hospital
state: Shanghai
Study officials:
affiliation: Zenshine Pharmaceuticals
name: Xiaoli Qin, PhD
role: STUDY_DIRECTOR
References: