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

NCT05938179 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 144

Last updated 2023-07-11

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Jiangsu Hansoh Pharmaceutical Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-08-31
Primary Completion
2024-11-01
Completion
2025-04-30

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05938179 on ClinicalTrials.gov