NCT06673927

A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Doses of YZJ-1139 in Healthy Participants

A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics of YZJ-1139 in Healthy Participants

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 104 (actual)
• Sponsor: Shanghai Haiyan Pharmaceutical Technology Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

Summary

Primary Objective： 1. To evaluate the tolerability, safety of single and multiple doses of YZJ-1139 in healthy participants 2. To evaluate the pharmacokinetic of single and multiple doses of YZJ-1139 in healthy participants Secondary objectives: To explore the safe tolerated dose of YZJ-1139, provide data support for the design of phase II dosing regimen

Conditions

• Insomnia

Interventions

Type	Name	Description
DRUG	YZJ-1139	Single oral dose, 2mg, 5mg, 10mg, 20mg, 40mg, 60mg, 80mg
DRUG	YZJ-1139	Multiple Dosing ，Each oral dose of 10 mg，20 mg，40 mg or 60 mg
DRUG	Placebo	Placebo administration

Timeline

• Start date: 2017-12-01
• Primary completion: 2018-11-21
• Completion: 2019-03-08
• First posted: 2024-11-05
• Last updated: 2025-02-10

Locations

1 site across 1 country: China