Ignite Creation Date:
2025-12-25 @ 4:22 AM
Ignite Modification Date:
2025-12-26 @ 3:25 AM
Study NCT ID:
NCT07101120
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-08-03
First Post:
2025-07-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Phase 2 Study to Evaluate Efficacy and Safety of KH607 Tablets in Adult Participents With Major Depressive Disorder
Sponsor:
Chengdu Kanghong Pharmaceutical Group Co., Ltd.
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2025-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: