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

Sponsor
Nanjing Zenshine Pharmaceuticals (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05217732
Collaborator
(none)
66
1
6
7.9
8.3

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
66 participants
Allocation:
Randomized
Intervention Model:
Sequential Assignment
Intervention Model Description:
single ascending doses in part 1 and fasting/nonfasting crossover in part 2single ascending doses in part 1 and fasting/nonfasting crossover in part 2
Masking:
Triple (Participant, Care Provider, Investigator)
Masking Description:
double-blind, placebo-controled study
Primary Purpose:
Treatment
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
Actual Study Start Date :
Dec 1, 2021
Anticipated Primary Completion Date :
Apr 16, 2022
Anticipated Study Completion Date :
Jul 30, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Single dose of ZX-7101A treatment A

Administrated as a single oral dose in healthy subjects

Drug: ZX-7101A
tablet

Drug: Placebo
Tablet

Experimental: Single dose of ZX-7101A treatment B

Administrated as a single oral dose in healthy subjects

Drug: ZX-7101A
tablet

Drug: Placebo
Tablet

Experimental: Single dose of ZX-7101A treatment C

Administrated as a single oral dose in healthy subjects

Drug: ZX-7101A
tablet

Drug: Placebo
Tablet

Experimental: Single dose of ZX-7101A treatment D

Administrated as a single oral dose in healthy subjects

Drug: ZX-7101A
tablet

Drug: Placebo
Tablet

Experimental: Single dose of ZX-7101A treatment E

Administrated as a single oral dose in healthy subjects

Drug: ZX-7101A
tablet

Drug: Placebo
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

Outcome Measures

Primary Outcome Measures

  1. Incidence and severity of adverse effect (TEAEs) and severe adverse events (SAEs) [Day 1-day15]

    safety and tolerability

Secondary Outcome Measures

  1. Peak plama concentration of ZX-7101A [Days 1-15]

    To evaluate the maximum observed concentration (Cmax) after single oral dose of ZX-7101A

  2. Area under the plasma concentration of ZX-7101A [Days 1-15]

    To evaluate the area under the curve (AUC) plasma-concentration after single oral dose of ZX-7101A

  3. Half-life of ZX-7101A [Days 1-15]

    To evaluate the half-life of ZX-7101A after single oral dose of ZX-7101A

  4. Concentration of ZX-7101A in urine [Days 1-15]

    To evaluate the concentration at a select treatment after single oral dose of ZX-7101A

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 45 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Fudan University affiliated Huashan Hospital Shanghai Shanghai China

Sponsors and Collaborators

  • Nanjing Zenshine Pharmaceuticals

Investigators

  • Study Director: Xiaoli Qin, PhD, Zenshine Pharmaceuticals

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Nanjing Zenshine Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT05217732
Other Study ID Numbers:
  • ZX-7101A-201
First Posted:
Feb 1, 2022
Last Update Posted:
Feb 1, 2022
Last Verified:
Jan 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Feb 1, 2022