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

NCT ID: NCT05217732

Last Updated: 2023-07-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-12-01
• Study Completion Date: 2022-12-19

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.

Conditions

Safety Issues; Tolerance; Pharmacokinetics; Food Effect

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Single dose of ZX-7101A treatment A

Administrated as a single oral dose in healthy subjects

Group Type: EXPERIMENTAL

ZX-7101A

Intervention Type: DRUG

tablet

Placebo

Intervention Type: DRUG

Tablet

Single dose of ZX-7101A treatment B

Administrated as a single oral dose in healthy subjects

Group Type: EXPERIMENTAL

ZX-7101A

Intervention Type: DRUG

tablet

Placebo

Intervention Type: DRUG

Tablet

Single dose of ZX-7101A treatment C

Administrated as a single oral dose in healthy subjects

Group Type: EXPERIMENTAL

ZX-7101A

Intervention Type: DRUG

tablet

Placebo

Intervention Type: DRUG

Tablet

Single dose of ZX-7101A treatment D

Administrated as a single oral dose in healthy subjects

Group Type: EXPERIMENTAL

ZX-7101A

Intervention Type: DRUG

tablet

Placebo

Intervention Type: DRUG

Tablet

Single dose of ZX-7101A treatment E

Administrated as a single oral dose in healthy subjects

Group Type: EXPERIMENTAL

ZX-7101A

Intervention Type: DRUG

tablet

Placebo

Intervention Type: DRUG

Tablet

ZX-7101A food effect

Administered as a selected, single oral dose of ZX-7101A in fasting state and non-fasting (with food) state.

Group Type: EXPERIMENTAL

ZX-7101A

Intervention Type: DRUG

tablet

Interventions

ZX-7101A

tablet

Intervention Type: DRUG

Placebo

Tablet

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Nanjing Zenshine Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Xiaoli Qin, PhD

Role: STUDY_DIRECTOR

Zenshine Pharmaceuticals

Locations

Fudan University affiliated Huashan Hospital

Shanghai, Shanghai Municipality, China

Countries

China

Other Identifiers

ZX-7101A-201

Identifier Type: -

Identifier Source: org_study_id