Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:38 PM
Ignite Modification Date:
2025-12-24 @ 9:38 PM
NCT ID:
NCT05217732
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.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT05217732
Study Brief:
Protocol Section:
NCT05217732