A Phase 1 Study of Y-3 in US Healthy Volunteers.

Launched by NEURODAWN PHARMACEUTICAL CO., LTD. · Jan 7, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new drug called Y-3 to see how safe it is and how it behaves in the body when given to healthy adults. The researchers will give participants either a dose of Y-3 (40 mg or 60 mg) or a placebo, which is a substance that looks like the drug but has no active ingredients. The goal is to understand how the drug is processed in the body and to ensure it is safe for use.

To be eligible for this study, participants need to be healthy adults aged 18 to 45, weigh at least 50 kg (about 110 lbs), and have a body mass index (BMI) between 19 and 28. They should not have any serious health conditions, allergies to Y-3, or be on any other medications or special diets. Participants will stay for four nights at the research facility, where they will take the drug or placebo once, answer questions about their health, and follow specific guidelines, such as not consuming alcohol or caffeine in excess. This study aims to gather important information about Y-3, which could help in its future use for treating various health conditions.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Medically documented as healthy at the time of screening as determined by their medical history, medical assessment, physical examination, 12-lead electrocardiogram (ECG), and clinical laboratory tests, etc.
• • 2. Within 18-45 years at the time of informed consent, inclusive.
• • 3. Body weight ≥ 50 kg for male and ≥ 45 kg for female, body mass index (BMI) within the range of 19 - 28 kg/m2, inclusive.
• • 4. Fully understand and provide a signed informed consent before performing any study-related procedures.
• • 5. Comply with the study and follow-up procedures.
• Exclusion Criteria:
• • 1. Known allergy to Y-3 or any of its excipients.
• • 2. Have disease history or current disease that may affect the safety evaluation of the subject or the internal process of the study drug, that the investigator judged to be of clinical significance, including the cardiovascular system, endocrine system, central nervous system, digestive system, respiratory system, hematological system, immunology, psychiatry, metabolic abnormalities, etc.
• • 3. Clinically significant abnormal 12-lead electrocardiograms (ECG) and vital signs judged by the investigator.
• • 4. Clinically significant abnormal laboratory tests (hematology, serum chemistry, coagulation, urinalysis, etc.) and other screening tests judged by the investigator.
• • 5. Test positive for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, syphilis antibody or human immunodeficiency virus (HIV) antibody.
• • 6. Alcoholics or regular drinkers within 6 months prior to screening, that is, those who drink more than 14 units of alcohol per week (1 unit = 360 mL of beer or 45 mL of alcohol with 40% alcohol content or 150 mL of wine), or whose alcohol breath test results are greater than 0.0 mg/100 mL, or who cannot abstain from alcohol during the study.
• • 7. Smokers, that is, those who smoke more than 3 cigarettes per day within 3 months prior to screening, or those who cannot comply with the prohibition of smoking during the study.
• • 8. Current or former drug users, or positive urine screen for drugs of abuse at screening.
• • 9. Have special requirements for diet and cannot follow the unified diet.
• • 10. Drink too much tea, coffee and/or caffeine-containing beverages (more than 8 cups, 1 cup = 250 mL) every day within 3 months prior to screening, or who have consumed any diet (food or beverage) rich in grapefruit, pitaya and mango within 14 days prior to screening.
• • 11. Have taken any prescription drug or over-the-counter drug, traditional Chinese medicine or herbal medicine, health products within 14 days prior to screening, or 5 half-lives, whichever is longer, before the first dose of study drug, or have received vaccine inoculation within 14 days prior to screening; or plan to inoculate vaccine during the study.
• • 12. Participated in any other clinical trials within 3 months prior to screening.
• • 13. Donation or loss of blood equal to or in excess of 200 mL within 3 months prior to screening.
• • 14. Female subjects who have unprotected intercourse within 14 days prior to screening, or pregnant or lactating women.
• • 15. Male subjects (or their partners) or female subjects have baby plans during the whole trial period and within 3 months after the end of the trial, or subjects are unwilling to take one or more non-drug contraceptive measures (such as complete abstinence, condoms, ligation, etc.) during the study.
• • 16. Subjects voluntarily withdraw from the study due to personal reason, or subjects who the investigator believes are not suitable for enrollment for other reasons.
• • 17. Suicidal ideation, history of suicidal behavior, or history of psychiatric comorbidities.