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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-31

Study Completion Date

2026-04-30

Brief Summary

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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.

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Detailed Description

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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

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Major Depressive Disorder (MDD)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Part A: KH607

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

Group Type EXPERIMENTAL

KH607 tablets

Intervention Type DRUG

oral 30mg , once daily for 14 days

Part B: Placebo

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

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

oral, once daily for 21 days

Part B: KH607 30mg

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

Group Type EXPERIMENTAL

KH607 tablets

Intervention Type DRUG

oral 30mg, once daily for 21 days

Part B: KH607 20mg

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

Group Type EXPERIMENTAL

KH607 tablets

Intervention Type DRUG

oral 20mg, once daily for 21 days

Interventions

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KH607 tablets

oral 30mg , once daily for 14 days

Intervention Type DRUG

placebo

oral, once daily for 21 days

Intervention Type DRUG

KH607 tablets

oral 20mg, once daily for 21 days

Intervention Type DRUG

KH607 tablets

oral 30mg, once daily for 21 days

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Age: 18 to 65 years old (inclusive), Male or female.
2. 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
3. Participant has a Hamilton Rating Scale for Depression (HAM-D) total score ≥24 at screening and Day 1 (prior to dosing).
4. Participants who is taking antidepressants must have stopped for 7 days or 5 half-lives of the antidepressant prior to Day 1.
5. 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.
6. Fully understand the procedures and sigh the informed consent.

Exclusion Criteria

1. Participant is currently at significant risk of suicide, or has attempted suicide associated with the current episode of MDD.
2. 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.
3. Participant has active psychosis.
4. 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.
5. Subject has a history of sleep apnea.
6. 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.
7. Participant has a clinically significant abnormal 12-lead ECG at the screening or baseline visits. NOTE: mean QT interval calculated using the Fridericia method (QTcF) of \>450 msec in males or \>470 msec in females will be the basis for exclusion from the study.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No