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

Kanghong Pharmaceutical

Status and phase: Not yet enrolling; Phase 2

Conditions: Major Depressive Disorder (MDD)

Treatments: Drug: placebo; Drug: KH607 tablets

Study type: Interventional

Funder types: Industry

Identifiers

NCT07101120

KH607-40101

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

key 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

120 participants in 4 patient groups, including a placebo group

Part A: KH607

Experimental group

Description:

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

Treatment:

Drug: KH607 tablets

Drug: KH607 tablets

Drug: KH607 tablets

Part B: Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: placebo

Part B: KH607 30mg

Experimental group

Description:

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

Treatment:

Drug: KH607 tablets

Drug: KH607 tablets

Drug: KH607 tablets

Part B: KH607 20mg

Experimental group

Description:

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

Treatment:

Drug: KH607 tablets

Drug: KH607 tablets

Drug: KH607 tablets