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

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

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.

Study Overview

• Status: Completed
• Conditions: Pharmacokinetics; Tolerance; Safety Issues; Food Effect
• Intervention / Treatment: Drug: Placebo; Drug: ZX-7101A

• Study Type: Interventional
• Enrollment (Actual): 66
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Li Luo; Phone Number: 86-15951876049; Email: luoli@zenshine-pharma.com
• Study Contact Backup: Name: Shun Yang; Email: yangshun@zenshine-pharma.com

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China
      • Fudan University affiliated Huashan Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Triple

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Single dose of ZX-7101A treatment A; Administrated as a single oral dose in healthy subjects	Drug: Placebo; Tablet; Drug: ZX-7101A; tablet
Experimental: Single dose of ZX-7101A treatment B; Administrated as a single oral dose in healthy subjects	Drug: Placebo; Tablet; Drug: ZX-7101A; tablet
Experimental: Single dose of ZX-7101A treatment C; Administrated as a single oral dose in healthy subjects	Drug: Placebo; Tablet; Drug: ZX-7101A; tablet
Experimental: Single dose of ZX-7101A treatment D; Administrated as a single oral dose in healthy subjects	Drug: Placebo; Tablet; Drug: ZX-7101A; tablet
Experimental: Single dose of ZX-7101A treatment E; Administrated as a single oral dose in healthy subjects	Drug: Placebo; Tablet; Drug: ZX-7101A; tablet
Experimental: ZX-7101A food effect; Administered as a selected, single oral dose of ZX-7101A in fasting state and non-fasting (with food) state.	Drug: ZX-7101A; tablet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence and severity of adverse effect (TEAEs) and severe adverse events (SAEs)	safety and tolerability	Day 1-day15

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Peak plama concentration of ZX-7101A	To evaluate the maximum observed concentration (Cmax) after single oral dose of ZX-7101A	Days 1-15
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
Half-life of ZX-7101A	To evaluate the half-life of ZX-7101A after single oral dose of ZX-7101A	Days 1-15
Concentration of ZX-7101A in urine	To evaluate the concentration at a select treatment after single oral dose of ZX-7101A	Days 1-15

Collaborators and Investigators

• Sponsor: Nanjing Zenshine Pharmaceuticals
• Investigators: Study Director: Xiaoli Qin, PhD, Zenshine Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2021
• Primary Completion (Actual): August 29, 2022
• Study Completion (Actual): December 19, 2022

Study Registration Dates

• First Submitted: January 19, 2022
• First Submitted That Met QC Criteria: January 19, 2022
• First Posted (Actual): February 1, 2022

Study Record Updates

• Last Update Posted (Actual): July 21, 2023
• Last Update Submitted That Met QC Criteria: July 20, 2023
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: ZX-7101A-201

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No