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:
2025-12-25 @ 3:16 AM
Ignite Modification Date:
2025-12-25 @ 3:16 AM
NCT ID:
NCT06304805
Eligibility Criteria:
Inclusion Criteria:
* able to understand the purpose, methods and possible adverse events of the study and agree to volunteering consent before the start of study
* healthy subject; male or female
* Age between 18 and 55 (inclusive)
* body mass index (BMI) between 19.0 and 26.0 (inclusive), male weight \<=50 kg, female weight \<=45 kg
* normal/ clinically insignificant test results (including physical exam, laboratory tests, 12-lead ECG, chest x-ray, etc.)
* participant/partner of the participant does not have plans for child bearing from screening until 6 months after study, and is willing to take contraceptive measures during study period and for 6 months, and does not have plans to donate sperm/egg during the said period
Exclusion Criteria:
* history of allergic reactions, or allergic to any components to the study drugs that by investigator's judgement unsuitable for the study
* any clinically significant conditions that could affect study outcomes, safety or compliance
* history of major surgery within 3 months before first dose, or have plans to receive surgery during the study, or history of any surgery that could affect drug absorption, distribution, metabolism and excretion
* have difficulties to receive venous needle puncture, or cannot tolerate venous needle puncture, or history of hematophobia or needle sickness
* history of substance abuse
* have special food requirement or cannot follow food requirement of the study, or lactose intolerant
* use of any investigational drug or participation of any clinical study (for drug or medical device) within 3 months before first dose, or cannot participate the study in person/on site
* history of blood donation, blood loss (\>= 400 mL, excluding normal blood loss during female menstrual period), or reception of blood transfusion within 3 months before screening
* history of daily cigarette consumption of more than 5 within 3 months before screening, or cannot avoid using cigarette/tabacco products during the study
* history of alcohol abuse (more than 14 units of alcohol per week) within 3 months before screening, or cannot avoid alcohol consumption during study
* history of large tea/coffee/caffeinated drink intake (more than 8 cups per day) within 3 months before first dose
* history of irregular dietary schedule within 1 months of first dose (including, dieting, overeating, low sodium intake, etc.)
* use of any prescription / over-the-counter drug, or Chinese herbal medication, or health supplementary products within 14 days of test article administration
* vaccination within 14 days before first test article administration, or have plans to receive vaccination during the study period
* any one positive result for hepatitis-B surface antigen, Hepatitis C antibody, HIV antibody or syphilis antibody
* alcohol breathing test results of \> 0.0 mg/100mL for blood alcohol concentration
* positive test results on substance use (including, morphine, methylamphetamine, ketamine, tetrahydrocannabinol, methylene-dioxy-methyl-amphetamine)
* female in pregnancy or breastfeeding period, or positive pregnancy test result
* history of unprotected sexual activities within 14 days before first dose
* consumption of food or drink rich in caffeine/xanthine (such as chocolate, coffee, tea, coke) or food/food product of grapefruit, dragon fruit, mango, tangerine, or any food that could affect drug absorption, distribution, metabolism and excretion
* any reasons that is deemed unsuitable for study participation as determined by investigator
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT06304805
Study Brief:
Protocol Section:
NCT06304805