NCT07101120

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

A Phase 2, Two-Part (Open-Label Followed by Double-Blind) Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of KH607 in the Treatment of Adult Participants With Moderate or Severe Major Depressive Disorder

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Chengdu Kanghong Pharmaceutical Group Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Part A is an open-label study with dosing of KH607 tablets for 14 days. Part B is a randomized, double-blind, parallel-group, placebo-controlled study. Eligible participants will be randomized to KH607 group or placebo group for 21 days.

Conditions

• Major Depressive Disorder (MDD)

Interventions

Type	Name	Description
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

Timeline

• Start date: 2025-08-01
• Primary completion: 2025-12-01
• Completion: 2026-04-01
• First posted: 2025-08-03
• Last updated: 2025-08-03