A Study of KH607 as Monotherpy in Adults Participants With Major Depressive Disorder

NCT07741240 | Not Yet Recruiting Phase 3

• 1 other identifier: KH607-60101
• Study Type: interventional
• Target: 232
• Locations: 0 countries
• Sites: N/A

Brief Summary

This trial includes a short-term study and a long-term study. The short-term study is a multicenter, randomized, double-blind, placebo-controlled parallel-group study with a 6-week duration. The long-term study is a multicenter, open-label, single-arm study with a maximum duration of 27 weeks.

Conditions

Major Depressive Disorder (MDD)

Outcome Measures

Primary Outcomes (1)

• Double Blind (DB) Treatment Phase: Change from Baseline in 17-item Hamilton Rating Scale for Depression (HAM-D17) Total Score in Participants with Major Depressive Disorder

  The HAM-D is a clinician-administered scale designed to measure depression severity and detects changes due to antidepressant treatment.HAM-D17 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.

  Baseline up to Day 22

Secondary Outcomes (20)

• Double Blind (DB) Treatment Phase: Change from Baseline in HAM-D17 Total Score in Participants with Major Depressive Disorder

  Baseline up to Day 42

• Double Blind (DB) Treatment Phase: Change from Baseline in the Montgomery and Åsberg Depression Rating Scale (MADRS) Total Score

  Baseline up to Day 42

• Double Blind (DB) Treatment Phase: Change from Baseline in Hamilton Anxiety Rating Scale (HAM-A) Total Score

  Baseline up to Day 42

• Double Blind (DB) Treatment Phase: Change from Baseline in Clinical Global Impressions-Severity (CGI-S) score

  Baseline up to Day 42

• Double Blind (DB) Treatment Phase:Change in Clinical Global Impressions-Improvement (CGI-I) score

  Baseline up to Day 42

Study Arms (3)

Part A: KH607

EXPERIMENTAL

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

Drug: KH607 tablets

Part A: Placebo

PLACEBO COMPARATOR

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

Drug: placebo

Part B: KH607

EXPERIMENTAL

All participants will receive 20 mg (2 tablets) KH607 Tablets QN before go to bed. Treatment will continue for 21 consecutive days, followed by a 6-week drug off-drug observation period. After completing Cycle 1, participants may enter Cycle 2 and Cycle 3 sequentially, up to a maximum of 3 treatment cycles. The maximum duration of the long-term study is 27 weeks.

Drug: KH607 tablets

Interventions

KH607 tablets DRUG

oral 20mg, once daily for 21 days

Part A: KH607

placebo DRUG

oral, once daily for 21 days

Part A: 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.
• Based on investigator's clinical assessment, study participants meet the diagnostic criteria for Major Depressive Disorder (MDD) as defined in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), with a diagnosis of single episode or recurrent episodes (ICD-10 codes: 296.2/296.3), without psychotic features. For patients with first-episode depression, the current episode must have a duration of ≥3 months; for patients with recurrent depression, the current depressive episode must have a duration of ≥1 month
• Depressive episode confirmed by the Mini International Neuropsychiatric Interview Version 7.0.0 (M.I.N.I. 7.0.0).
• Patients must have a 17-item Hamilton Depression Rating Scale (HAM-D17) total score ≥24, a Clinical Global Impression-Severity (CGI-S) score ≥4, and a score ≥2 on Item 1 (Depressed Mood) of the HAM-D17 at screening and baseline
• Body weight ≥45.0 kg for females or ≥50.0 kg for males, with a body mass index (BMI) ≥19 kg/m²
• 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 antidepressants, antipsychotics, mood stabilizers, sedatives and hypnotics during the trial.
• Fully understand the procedures and sigh the informed consent.
• Only for long-term studys:
• Participants who complete the short-term study (Visit 8 completion), have a ≥50% reduction from short-term study baseline in HAM-D17 total score at Visit 8, and volunteer to enter the long-term study.

You may not qualify if:

• Other psychiatric disorders meeting DSM-5 criteria, including but not limited to schizophrenia spectrum and other psychotic disorders, bipolar and related disorders, panic disorder, agoraphobia, social anxiety disorder, obsessive-compulsive disorder, post-traumatic stress disorder, generalized anxiety disorder, anorexia nervosa and bulimia nervosa, neurodevelopmental disorders, schizoaffective disorder, or any other psychiatric disorder that, in the Investigator's judgment, may compromise subject compliance.
• A reduction of ≥25% in HAM-D17 total score at baseline compared with the screening visit (this criterion does not apply if baseline and screening assessments are performed at the same visit).
• Participants with clinically significant risk of suicide or self-harm, defined as any of the following:
• A score ≥4 on Item 10 (Suicidal Thoughts) of the MADRS;
• An answer of "Yes" to Question 4 (active suicidal ideation with intent without specific plan) or Question 5 (active suicidal ideation with specific plan and intent) of the C-SSRS within the past 6 months at screening, or a suicide-related behavior within the past 6 months (any "Yes" response for Actual Attempt, Interrupted Attempt, or Aborted Attempt).
• Participants meeting any of the following depressive disorder diagnoses:
• Poor response to adequate dose and adequate duration (at least 6 weeks) of two or more antidepressants with distinct pharmacological mechanisms during a prior depressive episode (based on Investigator interview, to be adjudicated and documented by the Investigator);
• Depressive disorder secondary to other psychiatric disorders or somatic diseases (e.g., depression induced by hypothyroidism);
• Substance/medication-induced depressive disorder.
• Participants receiving structured psychotherapy (interpersonal therapy, psychodynamic therapy, cognitive behavioral therapy, etc.), music therapy, exercise therapy, acupuncture, or other therapies from screening through baseline, who require continuation of such therapies during the study.
• Receipt of depression-related neuromodulation therapies within 1 month prior to enrollment, including but not limited to modified electroconvulsive therapy (MECT), transcranial magnetic stimulation (TMS), vagus nerve stimulation (VNS), deep brain stimulation (DBS).
• Prior use of atypical antipsychotics or mood stabilizers during the current depressive episode (e.g., olanzapine, risperidone, quetiapine, aripiprazole, brexpiprazole, ziprasidone, cariprazine, valproate, lithium carbonate).
• Use of any strong CYP3A4 inhibitor or inducer within 14 days (or 5 half-lives, whichever is longer) prior to enrollment.
• Abnormal hepatic or renal function prior to enrollment: liver function abnormalities (ALT or AST \>2×ULN), renal function abnormalities (Cr \>1.5×ULN), or other conditions deemed inappropriate for enrollment by the Investigator.
• Positive test results at screening for active hepatitis B (HBV-DNA ≥1000 copies/mL or 200 IU/mL), hepatitis C antibody, syphilis antibody, or human immunodeficiency virus (HIV) antibody.

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 3
• 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 23, 2026
• First Posted: August 3, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: August 3, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share