NCT05938179

A Study of HS-10353 in Adult Participants With Major Depressive Disorder

A Multicenter, Randomized, Double-blind, Placebo-controlled Phase II Study Evaluating the Efficacy and Safety of HS-10353 in Chinese Adults With Depression.

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 144 (estimated)
• Sponsor: Jiangsu Hansoh Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This is a randomized, double-blind, placebo-controlled Phase II clinical study to evaluate the efficacy and safety of continuous oral administration of HS-10353 in Chinese adults with depression.HS-10353 is a new generation of GABAA receptor isomeric modulator developed by our company, which can correct the dysfunction of GABAA receptor function and restore the balance between GABA receptor and NMDA receptor. Oral administration of HS-10353 at night for 14 days is expected to reduce clinical symptoms in patients with depression. As an oral preparation of allopregnenolone analogitics, it has good bioavailability, rapid onset and high safety, and has broad clinical application prospects, which is expected to better meet the treatment needs of clinical depression in China in the future.

Conditions

• Major Depressive Disorder (MDD)

Interventions

Type	Name	Description
DRUG	HS-10353 30mg oral capsules	HS-10353 30mg oral capsules
DRUG	HS-10353 50mg oral capsules	HS-10353 50mg oral capsules
DRUG	Placebo for HS-10353 30mg capsules	Placebo for HS-10353 30mg capsules
DRUG	Placebo for HS-10353 50mg capsules	Placebo for HS-10353 50mg capsules

Timeline

• Start date: 2023-08-31
• Primary completion: 2024-11-01
• Completion: 2025-04-30
• First posted: 2023-07-10
• Last updated: 2023-07-11