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 @ 11:04 PM
Ignite Modification Date:
2025-12-24 @ 11:04 PM
NCT ID:
NCT05088369
Eligibility Criteria:
Key Inclusion Criteria:
1. Healthy male or non-childbearing potential female
2. BMI ≥18.0 and ≤32.0 kg/m2
3. Good health based on past medical history, medication use, vital signs and physical exam.
4. Normal renal and hepatic function.
5. Female partners of child bearing potential must agree to use contraception.
Key Exclusion Criteria:
1. Clinically significant medical history.
2. Significant drug allergy.
3. Use of experimental drug within 3 months prior.
4. Previously received HM201, AM and other derivatives.
5. History of old myocardial infarction.
6. Diagnosed with malignant tumor or history of treatment for malignant tumor.
7. History of drug or alcohol abuse.
8. Use of omitted medicines or substance opposing objective of study.
9. COVID19 vaccine administered within 14 days of initiation of investigational product or if to receive additional dose within 30 days of investigational product administration.
10. Use of tobacco/nicotine in excess of ≥ 5 cigarettes a day and unable or unwilling to prohibit smoking during admission to site.
11. Daily consumption of more than 1L of caffeine/xanthine beverage which cannot be discontinued more than 24 hours prior to dosing of investigational product and/or ECG measurement.
12. Regular use of nutraceuticals (e.g., St. John's wort, ginseng, ginkgo biloba, Chinese herbs, and melatonin) within 1 week before administration of investigational product.
13. Donation of plasma or platelet or 200 mL of whole blood within 4 weeks or 400 mL whole blood within 3 months before administration of investigational product.
14. Clinically relevant findings in ECG.
15. Systolic blood pressure below 100 mmHg or above 140 mmHg at screening.
16. Diastolic blood pressure above 90 mmHg at screening.
17. Heart rate below 40 beats/min or above 100 beats/min at screening.
18. Symptom of orthostatic hypotension is found at screening or before investigational product administration (Day -1).
19. Hepatitis B virus surface antigen (HBsAg), hepatitis B virus core antibody (HBcAb) hepatitis C virus antibodies (anti-HCV) or human immunodeficiency virus (HIV) antigen and antibody at screening.
20. Positive to syphilis.
21. Positive to urine drug test.
22. Positive alcohol breath test.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT05088369
Study Brief:
Protocol Section:
NCT05088369