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 @ 12:32 AM
Ignite Modification Date:
2025-12-25 @ 12:32 AM
NCT ID:
NCT07285967
Eligibility Criteria:
Inclusion Criteria:
* Participants who meet all the following criteria could be enrolled in this study:
1. Written informed consent obtained from the participant in compliance with all local legal requirements.
2. Male or female participant aged between 18 and 60 years (extremes included).
3. Body mass index (BMI) between 18-32 kg/m2 (extremes included) and body weight less than 120 kg.
4. Males must use a condom or remain abstinent during the trial and for 3 months after their last dose of study medication. And a fertile man's female partner must not try to become pregnant during the study.
5. Female participants of childbearing potential must be established on a highly effective method of contraception (The recommended birth control methods are: Implantable (e.g. Implanon(r)), injectable (e.g. Depo-Provera(r)), insertable (e.g. NuvaRing®), Mirena (r) (LNG-IUS)), Combined oral contraceptives pill or progestin-only pill, Evra patch®, Intrauterine device (e.g. ParaGard(r), copper T) or Female sterilization, Male sterilization. The recommended birth control methods must be taken at least 3 weeks prior to screening (i.e., to ensure the contraceptive method has taken effect).) prior to dosing and until 3 months after their last dose in combination with male partner's use of a condom during the trial and for 3 months after the last dose.
6. Free from any clinically relevant illness or disease that may adversely affect the safety of the participant, or the integrity of the study as determined by medical history, physical examination, safety laboratory, and other assessments.
7. Participants must be willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures. Without other intestinal diseases such as irritable bowel syndrome and acute diarrhea due to any infection.
Exclusion Criteria:
* If the participants meet any of the following criteria, they cannot be enrolled in this clinical trial:
1. Pregnant or lactating women.
2. Participants with dysphagia.
3. Severe infections requiring parenteral antibiotics treatment within 4 weeks prior to screening, e.g. sepsis, or severe pneumonia.
4. Any clinically relevant conditions e.g. cerebral stroke, myocardial infarction, heart failure, unstable angina, and severe heart rate abnormalities within 6 months before screening.
5. History or presence (within 6 months) of gastrointestinal, hepatic, or renal disease or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs.
6. Participant has a supine blood pressure outside the ranges of 90 to 140 mm Hg for systolic and 40 to 90 mm Hg for diastolic, confirmed with repeat per PI discretion, at the Screening Visit or Inpatient Check-in (Day -1).
7. Presence of any renal impairment or dysfunction (i.e. estimated glomerular filtration rate (eGFR)\<90 mL/ min).
8. Presence of hepatic impairment: Child-Pugh A, B or C and/or transaminase levels that are outside the upper normal limit (i.e., Serum bilirubin ≥1.5× upper limit of normal (ULN), ALT or AST levels \> ULN).
9. diagnosis of diabetes regardless the degree of control at screening visit
10. Hyperthyroidism or hypothyroidism.
11. Malignancy within 5 years, except for basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix that has been successfully treated.
12. Any major surgery within 6 months of screening.
13. Participant has a positive test result of HBV (positive HBsAg), HCV (positive anti-HCV), or human immunodeficiency virus I and II (positive anti-HIV I/II), Treponema Pallidum antibody (positive anti-TP) at screening.
14. Participants with innate or acquired immune system defects.
15. Participant has a resting heart rate outside the range of 40 to 100 bpm, confirmed with repeat per PI discretion, at the Screening Visit or Inpatient Check-in (Day -1).
16. Participant has an abnormal (CS) ECG at Screening or Inpatient Check-in (Day -1). Entry of any participant with an abnormal (NCS) ECG must be approved and documented by signature by the Investigator or a medically qualified sub-investigator.
17. Participant has a QT interval with Fridericia's correction method (QTcF) \>450 ms (males) or\>470 ms (females) or PR outside the range of 120 to 220 ms, confirmed with one repeat testing at the Screening Visit or Inpatient Check-in (Day -1) Visit; or history of risk factors for Torsades de Pointes (e.g., heart failure, hypokalemia, family history of Long QT Syndrome); or the use of concomitant medications that prolong the QT/QTc interval.
18. Participant has a history of a major psychiatric illness or currently receiving therapy for a psychiatric condition Participant has previously had a seizure or convulsion (lifetime, with the exception of febrile seizures), including absence seizure.
19. Taken any concomitant medications (including over-the-counter medications such as aspirin, acetaminophen, ibuprofen, herbal \[including traditional Chinese medicinal products\] or dietary supplements and cough syrup, as well as medicines requiring a prescription) within 14 days or 5 half-lives (whichever is longer), or St John's Wort within 30 days before the study drug administration.
20. Current use of strong inhibitors/inducers/substrates of CYP3A4, CYP3A5 and CYP2C8 with a narrow therapeutic index within 14 days before the study drug administration.
21. Participants were treated with another investigational drug, biological agent, or device within 1 month of screening, or 5 half-lives of investigational agent, whichever is longer.
22. Hypersensitivity to PA032 (active substance) or to any of the excipients.
23. Participant has a history of drug abuse or a history of alcohol abuse (more than 14 units/week, 1 unit=285 ml of beer, or 250 ml of spirit or 125 ml wine) within 1 year prior to the Screening Visit or is unwilling to agree to abstain from alcohol and drugs throughout the study.
24. Participant who regularly use nicotine-containing products (including but not limited to cigarettes, electronic cigarettes, pipes, cigars, chewing tobacco, nicotine patch, or nicotine gum) or a positive urine cotinine test at Inpatient Check-in (Day -1). The casual users may participate but must agree to refrain from the time of Screening for the duration of the study.
25. Participant has a positive urine result for drugs of abuse at Screening or Inpatient Check-in (Day -1).
26. Participant has a positive Alcohol breath test result at check-in (Day -1).
27. Participant has evidence of CS neurologic, cardiovascular, pulmonary, hepatic, hematopoietic disease, renal, metabolic, gastrointestinal, urologic, immunologic, endocrine disease, serious allergy, full-body allergic skin rash (including hives), psychiatric disorder, evidence of abnormal liver function test, evidence of abnormal renal function tests or other abnormality that may impact the ability of the participant to participate or potentially confound the study results.
28. Participant has poor peripheral venous access (defined as more than three failed attempts to cannulate.
29. Blood or plasma donation within 60 days prior to Day 1. Participants receive blood product transfusion within 90 days before screening.
30. Males intend to donate sperm or female to donate ova(eggs) during the study and within 3 months after last dose.
31. Employee or direct relative of an employe
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT07285967
Study Brief:
Protocol Section:
NCT07285967