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

NCT05217732 | Completed Phase 1 DMC

• 1 other identifier: ZX-7101A-201
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Incidence and severity of adverse effect (TEAEs) and severe adverse events (SAEs)

  safety and tolerability

  Day 1-day15

Secondary Outcomes (4)

• Peak plama concentration of ZX-7101A

  Days 1-15

• Area under the plasma concentration of ZX-7101A

  Days 1-15

• Half-life of ZX-7101A

  Days 1-15

• Concentration of ZX-7101A in urine

  Days 1-15

Study Arms (6)

Single dose of ZX-7101A treatment A

EXPERIMENTAL

Administrated as a single oral dose in healthy subjects

Drug: ZX-7101A; Drug: Placebo

Single dose of ZX-7101A treatment B

EXPERIMENTAL

Administrated as a single oral dose in healthy subjects

Drug: ZX-7101A; Drug: Placebo

Single dose of ZX-7101A treatment C

EXPERIMENTAL

Administrated as a single oral dose in healthy subjects

Drug: ZX-7101A; Drug: Placebo

Single dose of ZX-7101A treatment D

EXPERIMENTAL

Administrated as a single oral dose in healthy subjects

Drug: ZX-7101A; Drug: Placebo

Single dose of ZX-7101A treatment E

EXPERIMENTAL

Administrated as a single oral dose in healthy subjects

Drug: ZX-7101A; Drug: Placebo

ZX-7101A food effect

EXPERIMENTAL

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

Drug: ZX-7101A

Interventions

ZX-7101A DRUG

tablet

Single dose of ZX-7101A treatment A; Single dose of ZX-7101A treatment B; Single dose of ZX-7101A treatment C; Single dose of ZX-7101A treatment D; Single dose of ZX-7101A treatment E; ZX-7101A food effect

Placebo DRUG

Tablet

Single dose of ZX-7101A treatment A; Single dose of ZX-7101A treatment B; Single dose of ZX-7101A treatment C; Single dose of ZX-7101A treatment D; Single dose of ZX-7101A treatment E

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nanjing Zenshine Pharmaceuticals: lead

Study Sites (1)

Fudan University affiliated Huashan Hospital

Shanghai, Shanghai Municipality, China

Location

Study Officials

• Xiaoli Qin, PhD

  Zenshine Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: double-blind, placebo-controled study
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: single ascending doses in part 1 and fasting/nonfasting crossover in part 2

Study Record Dates

• First Submitted: January 19, 2022
• First Posted: February 1, 2022
• Study Start: December 1, 2021
• Primary Completion: August 29, 2022
• Study Completion: December 19, 2022
• Last Updated: July 21, 2023

Record last verified: 2022-01

Locations

CN (1)