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 @ 12:03 PM
Ignite Modification Date:
2025-12-24 @ 12:03 PM
NCT ID:
NCT06698861
Eligibility Criteria:
Inclusion Criteria:
1. Able to understand and voluntarily sign an informed consent form (ICF);
2. Age ≥18 and ≤45 years of age at the time of informed consent;
3. Subjects with a body weight ≥ 50 kg and with a body mass index (BMI) of ≥18.5 and \<30 kg/m2;
4. Subjects who are non-smokers for at least 24 weeks preceding Screening;
5. Males and females of childbearing potential, as well as all women \<2 years after the onset of menopause, must agree to use effective methods of contraception during the entire study period and for 12 weeks after dosing on Day 1; and females must agree to not breastfeed during the study;
6. Subjects who are healthy as determined by pre-study medical his-tory, physical examination, and 12-lead ECG;
7. Subjects whose clinical laboratory test results are within the refer-ence ranges for hematological parameters at Screening and admis-sion (Day -1 or Day 1 pre-dose). All other clinical laboratory test results must be within the reference range or judged not to be clini-cally significant and acceptable to the Investigator.
Exclusion Criteria:
1. Clinically significant illness or surgery within 28 days prior to Dosing;
2. Subjects have previously received G-CSF-related products;
3. Donation of blood or any blood loss \> 500 mL in the last 12 weeks prior to Screening;
4. Clinically significant vital sign abnormalities after ≥ 5 minutes supine or sitting rest, defined as any of the following values at Screening or admission (Day -1):
* systolic blood pressure \<90 or ≥ 140 mmHg; or
* diastolic blood pressure \<50 or ≥ 90 mmHg; or
* pulse rate \<50 or \>100 beats per minutes.
5. Subjects who have any clinically important abnormalities in the 12-lead ECG at Screening as considered by the Investigators that may pose a risk to subjects or interfere with the interpretation of QTc interval changes;
6. Subjects who have a prolonged QTcF \>450 ms at Screening or family history of long QT syndrome;
7. Subjects with history of drug or alcohol abuse; or those with positive result in the drug or ethanol examination at Screening or admission (Day -1);
8. Subjects who are positive for hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab), or human immunodeficiency virus (HIV) antibody at Screening;
9. Subjects with latex hypersensitivity or those have a history of severe allergy and/or severe drug reaction (e.g., anaphylaxis, other drug reaction requiring hospitalization, OR any other drug hypersensitivity); or those have known allergic reactions to any component of the treatments in this study;
10. Immunization with a live attenuated vaccine during a 28-day period prior to dosing, immunization with an inactivated or mRNA vaccine during a 14-day period prior to dosing, or planned immunization of any kind of vaccine during the course of the study;
11. Subjects with syphilis or those have a clinically significant history or evidence of any active or suspected bacterial, viral, fungal or parasitic infection, or unexplained cause of clinically significant inflammatory, within the 28 days prior to Dosing, e.g., common cold, viral syndrome, flu-like symptoms, etc;
12. Subjects who have acute gastrointestinal symptoms at Screening or admission (Day -1) (e.g., nausea, vomiting, diarrhea, and heartburn);
13. Take any prescription drugs within 14 days or nonprescription drugs (except routine vitamins at the recommended daily dose) within 7 days prior to Dosing were not allowed unless specified in the protocol or agreed as not clinically relevant by the Principal Investigator;
14. History of body organ transplant and are taking immunosuppressants at Screening; subject with history of bone marrow/hematopoietic stem cell transplantation, regardless of whether s/he is taking immunosuppressants at Screening, will be excluded;
15. Subjects who have received other investigational product within the last 12 weeks or within 5 times the half-life prior to Screening, whichever is longer;
16. Subjects who have received drugs containing lithium, systemic immunosuppressants, e.g., corticosteroid, or herbal remedies within 28 days prior to screening;
17. Subjects who have consumed grapefruit, grapefruit juice or other products containing grapefruit within 7 days prior to Dosing;
18. History of any malignant disease, including solid tumor and hematologic malignancies;
19. Pregnant subjects;
20. Subjects who are unlikely to co-operate with the requirements of the study;
21. Any reason which, in the opinion of the investigator, would prevent the subject from participating in the study.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT06698861
Study Brief:
Protocol Section:
NCT06698861