Testing the safety and effects of Y-3 in healthy adults

A Randomized, Double-blind, Placebo-controlled, Single Ascending Dose Phase 1 Study to Assess the Safety, Tolerability, and Pharmacokinetic Profiles of Y-3 in Healthy Adult Volunteers in the United States

This study is testing the safety and effects of a new drug called Y-3 in healthy adults aged 18 to 45 to see how it works compared to a placebo.

Quick facts

• Phase: PHASE1
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 18 Years to 45 Years
• Sex: All
• Sponsor: Neurodawn Pharmaceutical Co., Ltd. (industry)
• Locations: 1 site (Webster, Texas)
• Trial ID: NCT06770491 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the safety, tolerability, and pharmacokinetic profiles of the drug Y-3 in healthy adult volunteers aged 18 to 45 in the United States. Participants will receive either a single dose of Y-3 (40 mg or 60 mg) or a placebo and will undergo medical assessments, including a review of their medical history and physical examinations. The study will compare the pharmacokinetic profiles of Y-3 against a placebo to determine its safety and tolerability in this population.

Who should consider this trial

Good fit: Ideal candidates for this study are healthy adults aged 18 to 45 who meet specific health criteria.

Not a fit: Patients with known allergies to Y-3 or those with significant health issues may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide valuable information on the safety and pharmacokinetics of Y-3, potentially leading to its use in treating conditions like stroke.

How similar studies have performed: While this study focuses on a specific drug, similar pharmacokinetic studies have shown success in assessing new treatments, indicating a potentially promising approach.

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.

Where this trial is running

Webster, Texas

• Tranquil Clinical Research — Webster, Texas, United States (RECRUITING)

Study contacts

• Study coordinator: Mohammed

Conditions: Safety, Tolerability, Pharmacokinetic Study in Healthy Volunteers, safety, tolerability, Pharmacokinetic study in healthy volunteers, Y-3, stroke