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 @ 9:37 PM
Ignite Modification Date:
2025-12-24 @ 9:37 PM
NCT ID:
NCT05960032
Eligibility Criteria:
Inclusion Criteria:
* Healthy Chinese adults and includes participants who are between 18 to 55 years old
* BMI of 18 to 30 kg/m\^2; and a total body weight ≥50 kg (110 lb) for males and ≥45 kg (99 lb) for females
* Non-smoker (no use of tobacco or nicotine products).
Exclusion Criteria:
* Evidence or history of clinically significant disease.
* Use of medication other than topical products without significant systemic absorption.
* Previous participantion in a clinical research study or investigational study prior to the first dosing.
* Any clinically significant abnormal laboratory test results or positive test.
* Evidence of organ dysfunction or any clinically significant deviation from normal.
* Screening supine BP ≥140 mm Hg (systolic) or ≥90 mm Hg (diastolic).
* Standard 12-lead ECG that demonstrates clinically relevant abnormalities.
* Abnormalities in clinical laboratory tests: AST or ALT level \> ULN; Total bilirubin level \> ULN; ANC or ALC level \> ULN.
* Positive urine drug screen, alcohol breath test, or urine cotinine test.
* Positive pregnancy test.
* Positive result for COVID-19.
* History of significant alcohol abuse or drug abuse.
* History of anaphylaxix reaction or a clinically important reaction to any drug.
* Donation of plasma within 30 days prior to dosing. Donation or loss of blood of approximately 400 mL or more within 60 days prior to dosing.
* Inability to be venipunctured and/or tolerate catheter venous access.
* Habitual use of snuff tobacco.
* History of sensitivity to heparin or heparin-induced thrombocytopenia.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT05960032
Study Brief:
Protocol Section:
NCT05960032