NCT06770491

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Neurodawn Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The goal of this clinical trial is to assess the safety, tolerability, and pharmacokinetic profiles of Y-3 in healthy adult volunteers in the United States. The main questions it aims to answer are: * What the pharmacokinetic profiles of single ascending doses of Y-3 (40 mg and 60 mg) in the US healthy adult volunteers? * If drug Y-3 (40mg and 60 mg) is safe and tolerate in the US healthy adult volunteers. Researchers will compare drug Y-3 (40 mg and 60 mg) to a placebo (a look-alike substance that contains no drug) to see what the pharmacokinetic profiles of single ascending doses of Y-3 (40 mg and 60 mg) in the US healthy adult volunteers and if drug Y-3 (40mg and 60 mg) is safe and tolerate in the US healthy adult volunteers. Participants will: * Take drug Y-3 (40 mg) or Y-3 (60 mg) or a placebo only once. * Answer questions regarding your medical history. * Comply with the study procedures and requests. * Complete all tests and collections of PK Sampling. * Must not have any special dietary requirements and be able to consume the food (low-fat) provided by Tranquil Clinical Research during your 4-night stay. * Must avoid excessive ( \> 8 cups per day) caffeine consumption (i.e. coffee or tea) during your time in the study. * Must not consume any food or beverage rich in grapefruit, papaya, or mango during your time in the study. * Must not take any other medications, including traditional Chinese medicines and herbal medicines, during your time in the study. * Must avoid sexual activity or use non-drug contraceptive measures (i.e. condoms) during your time in the study. * Female participants must not become pregnant while in the study. * Must not receive any vaccinations during your time in the study. * Must not donate blood for purposes outside of study procedures during your time in the study. * Must not drink alcohol during your time in the study. * Must not smoke during your time in the study. * Inform your Study Doctor if you no longer wish to participate in the study.

Conditions

• Safety
• Tolerability
• Pharmacokinetic Study in Healthy Volunteers

Interventions

Type	Name	Description
DRUG	Y-3 for injection	The investigational drug (Y-3) consists of two parts: Y-3 for injection (lyophilized powder) and Solvent for Y-3 for injection (concentrated solution). Name: Y-3 for injection Strength: 20 mg Dosage Form: Lyophilized powder for injection Storage Condition: 2-8°C Supplier: Neurodawn Pharmaceutical Co., Ltd. Name: Reconstitution diluent for Y-3 for injection Strength: 3ml (containing 0.6 g propylene glycol) Dosage Form: Concentrated solution for injection Storage Condition: 2-8°C Supplier: Neurodawn Pharmaceutical Co., Ltd.
DRUG	Placebo	The placebo consists of two parts: placebo (lyophilized powder) and Solvent for Y-3 for injection(concentrated solution). Name: Placebo Strength: 0 mg Dosage Form: Lyophilized powder for injection Storage Condition: 2-8°C Supplier: Neurodawn Pharmaceutical Co., Ltd. Name: Solvent for Y-3 for injection Strength: 3 mL (containing 0.6 g propylene glycol) Dosage Form: Concentrated solution for injection Storage Condition: 2-8°C Supplier: Neurodawn Pharmaceutical Co., Ltd.

Timeline

• Start date: 2025-02-04
• Primary completion: 2025-09-20
• Completion: 2025-09-20
• First posted: 2025-01-13
• Last updated: 2025-12-18

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study