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drugset / Trial / NCT06673927

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

NCT06673927 ↗

Phase 1 Completed 104 enrolled Shanghai Haiyan Pharmaceutical Technology Co., Ltd.
RandomizedParallel-groupDouble-blindTreatment

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

Timeline

Start
2017-12-01
Primary completion
2018-11-21
Completion
2019-03-08

Drugs

EvaluationDrugModalityDoseRoute
Subject FAZAMOREXANT Small molecule 2 mg Oral
Subject FAZAMOREXANT Small molecule 5 mg Oral
Subject FAZAMOREXANT Small molecule 10 mg Oral
Subject FAZAMOREXANT Small molecule 20 mg Oral
Subject FAZAMOREXANT Small molecule 40 mg Oral
Subject FAZAMOREXANT Small molecule 60 mg Oral
Subject FAZAMOREXANT Small molecule 80 mg Oral

Indications

insomnia