NCT06964711

GW117 ODT （Orally Disintegrating Tablets） Safety and Pharmacokinetics Study in Healthy Subjects

A Randomized, Double-Blind, Placebo-Controlled, Single Dose and Multiple Ascending Dose, Single Center Phase1 Study of Safety, Tolerability and Pharmacokinetics of GW117 ODT in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 92 (actual)
• Sponsor: Beijing Greatway Pharmaceutical Technology Co.,Ltd. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

To evaluate the safety, tolerability and pharmacokinetics of single and multiple ascending doses of GW117 ODT in healthy volunteers

Detailed description

Single ascending dose (SAD), multiple ascending dose (MAD), double-blind placebo-controlled study in Chinese healthy volunteers.

Conditions

• Major Depressive Disorder

Interventions

Type	Name	Description
DRUG	GW117 ODT	Sublingual route ， 0.5mg/1mg/2mg/4mg，QD
DRUG	Placebo	GW117 Placebo matching for Sublingual route ，QD

Timeline

• Start date: 2021-07-12
• Primary completion: 2023-03-24
• Completion: 2023-03-24
• First posted: 2025-05-09
• Last updated: 2025-05-09

Locations

1 site across 1 country: China