MedTrace Logo

A Phase 2 Study to Evaluate Efficacy and Safety of KH607 Tablets in Adult Participents With Major Depressive Disorder

NCT07101120 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2025-08-03

No results posted yet for this study

Summary

This is a two-part (open-label followed by double-blind) study evaluating the safety, tolerability, pharmacokinetics, and efficacy of KH607 in 120 participants diagnosed with moderate or severe Major Depressive Disorder.

Conditions

  • Major Depressive Disorder (MDD)

Interventions

DRUG

KH607 tablets

oral 30mg , once daily for 14 days

DRUG

placebo

oral, once daily for 21 days

DRUG

KH607 tablets

oral 20mg, once daily for 21 days

DRUG

KH607 tablets

oral 30mg, once daily for 21 days

Sponsors & Collaborators

  • Chengdu Kanghong Pharmaceutical Group 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
2025-08-31
Primary Completion
2025-12-31
Completion
2026-04-30

More Related Trials

Entities

Drugs

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 NCT07101120 on ClinicalTrials.gov