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

PHASE1RecruitingINTERVENTIONAL
Enrollment

20

Participants

Timeline

Start Date

January 6, 2025

Primary Completion Date

April 25, 2025

Study Completion Date

August 30, 2025

Conditions
SafetyTolerabilityPharmacokinetic Study in Healthy Volunteers
Interventions
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."

Trial Locations (1)

77598

RECRUITING

Tranquil Clinical Research, Webster

All Listed Sponsors
lead

Neurodawn Pharmaceutical Co., Ltd.

INDUSTRY