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

NCT07101120 | Not Yet Recruiting Phase 2

• 1 other identifier: KH607-40101
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Major Depressive Disorder (MDD)

Outcome Measures

Primary Outcomes (2)

• Change From Baseline in the 17-item Hamilton Rating Scale for Depression (HAM-D17) Total Score at Day 15 - Part A

  The HAM-D total score comprised a sum of 17 individual item scores.The total score could range from 0 to 52. Higher scores indicated a greater degree of depression. The analysis was performed in participants included in Part B of the study.

  Baseline to Day 15

• Change From Baseline in the 17-item Hamilton Rating Scale for Depression (HAM-D17) Total Score at Day 22 - Part B

  The HAM-D total score comprised a sum of 17 individual item scores.The total score could range from 0 to 52. Higher scores indicated a greater degree of depression. The analysis was performed in participants included in Part B of the study.

  Baseline to Day 22

Secondary Outcomes (18)

• Part A：Pharmacokinetic parameters of KH607 tablets (Cmax）

  Part A: Day 1 to Day 21.

• Change From Baseline in the 17-item Hamilton Rating Scale for Depression (HAM-D17) Total Score at Day 15 - Part A

  Part A: Day 15

• Change From Baseline in the 17-item Hamilton Rating Scale for Depression (HAM-D17) Total Score at all other time points - Part A

  Part A: Day 3,8,12,21,28

• Change From Baseline in the Montgomery and Åsberg Depression Rating Scale (MADRS) Total Score at Day 15 and All Other Time Points - Part A

  Part A: Day 3,8,12,15,21,28

• Change From Baseline in Hamilton Anxiety Rating Scale (HAM-A) Total Score at All Time Points - Part A

  Part A: Day 3,8,12,15,21,28

Study Arms (4)

Part A: KH607

EXPERIMENTAL

Participants receive KH607, 30 milligrams (mg), oral tablets, once daily for 14 days, as tolerated.

Drug: KH607 tablets

Part B: Placebo

PLACEBO COMPARATOR

Eligible participants receive matching placebo tabels once daily for 21 days.

Drug: placebo

Part B: KH607 30mg

EXPERIMENTAL

Participants receive KH607, 30 milligrams (mg), oral tablets, once daily for 21 days.

Drug: KH607 tablets

Part B: KH607 20mg

EXPERIMENTAL

Participants receive KH607, 20 milligrams (mg), oral tablets, once daily for 21 days.

Drug: KH607 tablets

Interventions

KH607 tablets DRUG

oral 30mg , once daily for 14 days

Part A: KH607

placebo DRUG

oral, once daily for 21 days

Part B: Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age: 18 to 65 years old (inclusive), Male or female.
• Participant with diagnosis of MDD as diagnosed by Structured Clinical Interview for Diagnostic and Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) , with symptoms that have been present for at least a 4-week period
• Participant has a Hamilton Rating Scale for Depression (HAM-D) total score ≥24 at screening and Day 1 (prior to dosing).
• Participants who is taking antidepressants must have stopped for 7 days or 5 half-lives of the antidepressant prior to Day 1.
• Participant is willing to stop other antidepressant or antianxiety medications and any new pharmacotherapy regimens, including as-needed benzodiazepine anxiolytics and sleep aids, until after completion of the Day 42 visit.
• Fully understand the procedures and sigh the informed consent.

You may not qualify if:

• Participant is currently at significant risk of suicide, or has attempted suicide associated with the current episode of MDD.
• Participant has a history of treatment-resistant depression, defined as persistent depressive symptoms despite treatment with adequate doses of antidepressants from two different classes for an adequate amount of time.
• Participant has active psychosis.
• Participant had used modified electroconvulsive therapy (MECT), transcranial magnetic stimulation (TMS), vagus nerve stimulation (VNS), deep brain stimulation (DBS), light therapy, etc. within 1 month prior to Day 1.
• Subject has a history of sleep apnea.
• Participant has a medical history of bipolar disorder, schizophrenia, and/or schizoaffective disorder (such as olanzapine, risperidone, quetiapine, aripiprazole, eptifamol, ziprasidone, caliparazine, sodium valproate, lithium carbonate, etc.) within the current major depressive episode.

Sponsors & Collaborators

• Chengdu Kanghong Pharmaceutical Group Co., Ltd.: lead

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Central Study Contacts

Gang Wang, Medical Doctor

CONTACT

86-010-58303063; adgangwang@163.com

Bing Bing Fu, Medical Doctor

CONTACT

86-010-58303063; fbbkidd@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 24, 2025
• First Posted: August 3, 2025
• Study Start: August 1, 2025
• Primary Completion: December 1, 2025
• Study Completion: April 1, 2026
• Last Updated: August 3, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share