Major Depressive Disorder (MDD)Phase 2NCT07101120
A Phase 2 Study to Evaluate Efficacy and Safety of KH607 Tablets in Adult Participents With Major Depressive Disorder
A Phase 2 study testing KH607 tablets in people with Major Depressive Disorder (MDD), run by Chengdu Kanghong Pharmaceutical Group Co., Ltd. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Major Depressive Disorder (MDD)
- What is being tested?
- KH607 tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 126 participants
- Where
- 1 siteChina
- Study dates
- 19 Mar 2025to 9 Feb 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
- 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 locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Major Depressive Disorder (MDD)
- Being tested
- KH607 tablets, placebo
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KH607 tabletsDrug
oral 30mg , once daily for 14 days
placeboDrug
oral, once daily for 21 days
KH607 tabletsDrug
oral 20mg, once daily for 21 days
KH607 tabletsDrug
oral 30mg, once daily for 21 days
| Study group | Role | What they receive |
|---|---|---|
| Part A: KH607 | Experimental | Participants receive KH607, 30 milligrams (mg), oral tablets, once daily for 14 days, as tolerated. Receives: Drug: KH607 tablets |
| Part B: Placebo | Placebo comparator | Eligible participants receive matching placebo tabels once daily for 21 days. Receives: Drug: placebo |
| Part B: KH607 30mg | Experimental | Participants receive KH607, 30 milligrams (mg), oral tablets, once daily for 21 days. Receives: Drug: KH607 tablets |
| Part B: KH607 20mg | Experimental | Participants receive KH607, 20 milligrams (mg), oral tablets, once daily for 21 days. Receives: Drug: KH607 tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline to Day 22
Secondary outcomes (18)
Part A：Pharmacokinetic parameters of KH607 tablets (Cmax）
Maximum observed plasma concentration following administration
Measured: 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
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.
Measured: 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
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.
Measured: 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
The MADRS was a ten-item diagnostic questionnaire which psychiatrists used to measure the severity of depressive episodes in participants with mood disorders. It was designed as an adjunct to the HAM-D, to be more sensitive than the Hamilton Scale to the changes brought on by antidepressants and other forms of treatment. Each item yielded a score of 0 to 6. The MADRS total score was calculated as the sum of the 10 individual item scores, which ranged from 0 to 60. Higher MADRS scores indicated more severe depression. A negative change from baseline indicated less severe depression. A positive change from baseline indicated more severe depression. The analysis was performed in participants included in Part A of the study.
Measured: 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
The 14-item HAM-A was used to rate the severity of symptoms of anxiety. Each of the 14 items was defined by a series of symptoms, and measured both psychic anxiety (mental agitation and psychological distress) and somatic anxiety (physical complaints related to anxiety). Scoring for HAM-A was calculated by assigning scores of 0 (not present) to 4 (very severe), with a total score range of 0 to 56. The HAM-A total score was calculated as the sum of the 14 individual item scores. A negative change from baseline indicated less anxiety. A positive change from baseline indicated more anxiety. The analysis was performed in participants included in Part A of the study.
Measured: Part A: Day 3,8,12,15,21,28
Percentage of Participants With Clinical Global Impression - Severity (CGI-S) Response - Part A
The CGI-S item employed a 7-point Likert scale to measure the overall severtity in the participant's condition. The analysis was performed in participants included in Part A of the study.
Measured: Part A: Day 3,8,12,15,21,28
Percentage of Participants With Clinical Global Impression - Improvement (CGI-I) Response - Part A
The CGI-I item employed a 7-point Likert scale to measure the overall improvement in the participant's condition post-treatment. The investigator rated the participant's total improvement whether or not it was due entirely to drug treatment. The CGI-I was only rated at post-treatment assessments. By definition, all CGI-I assessments were evaluated against baseline conditions. CGI-I response was defined as having a CGI-I global improvement score of 1 (very much improved) or 2 (much improved). The analysis was performed in participants included in Part A of the study. Data is reported for participants who had CGI-I response.
Measured: Part A: Day 3,8,12,15,21,28
Percentage of Participants With HAM-D Response - Part A
HAM-D response was defined as having a 50% or greater reduction from baseline in HAM-D total score. The analysis was performed in participants included in Part A of the study. Data is reported for participants who had HAM-D response.
Measured: Part A: Day 3,8,12,15,21,28
Percentage of Participants With HAM-D Remission - Part A
HAM-D remission was defined as having a HAM-D total score of ≤7. The analysis was performed in participants included in Part A of the study.
Measured: Part A: Day 3,8,12,15,21,28
Change From Baseline in the 17-item Hamilton Rating Scale for Depression (HAM-D17) Total Score at all other time points - 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.
Measured: Part B: Day 3,8,15,28,35,42
Change From Baseline in the Montgomery and Åsberg Depression Rating Scale (MADRS) Total Score at Day 15 and All Other Time Points - Part B
The MADRS was a ten-item diagnostic questionnaire which psychiatrists used to measure the severity of depressive episodes in participants with mood disorders. It was designed as an adjunct to the HAM-D, to be more sensitive than the Hamilton Scale to the changes brought on by antidepressants and other forms of treatment. Each item yielded a score of 0 to 6. The MADRS total score was calculated as the sum of the 10 individual item scores, which ranged from 0 to 60. Higher MADRS scores indicated more severe depression. A negative change from baseline indicated less severe depression. A positive change from baseline indicated more severe depression. The analysis was performed in participants included in Part A of the study.
Measured: Part B: Days3, 8, 15, 22,28,35 and 42
Change From Baseline in Hamilton Anxiety Rating Scale (HAM-A) Total Score at All Time Points - Part B
The 14-item HAM-A was used to rate the severity of symptoms of anxiety. Each of the 14 items was defined by a series of symptoms, and measured both psychic anxiety (mental agitation and psychological distress) and somatic anxiety (physical complaints related to anxiety). Scoring for HAM-A was calculated by assigning scores of 0 (not present) to 4 (very severe), with a total score range of 0 to 56. The HAM-A total score was calculated as the sum of the 14 individual item scores. A negative change from baseline indicated less anxiety. A positive change from baseline indicated more anxiety. The analysis was performed in participants included in Part A of the study.
Measured: Part B: Days3, 8, 15, 22,28,35 and 42
Percentage of Participants With Clinical Global Impression - Severity (CGI-S) Response - Part B
Measured: Part B: Days3, 8, 15, 22,28,35 and 42
Percentage of Participants With Clinical Global Impression - Improvement (CGI-I) Response - Part B
Measured: Part B: Days3, 8, 15, 22,28,35 and 42
Percentage of Participants With HAM-D Response - Part B
Measured: Part B: Days3, 8, 15, 22,28,35 and 42
Percentage of Participants With HAM-D Remission - Part B
Measured: Part B: Days3, 8, 15, 22,28,35 and 42
Part A：Pharmacokinetic parameters of KH607 tablets（Tmax）
Time to reach the maximum observed plasma concentration following administration
Measured: Part A: Day 1 to Day 21.
Part A：Pharmacokinetic parameters of KH607 tablets（AUC0-inf）
The AUCs is the area under the plasma concentration-time curve from time 0 to the Infinity post-dose.
Measured: Part A: Day 1 to Day 21.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2025
- Study start19 Mar 2025
- Primary completion9 Feb 2026
- Study completion9 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive Disorder (MDD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chengdu Kanghong Pharmaceutical Group Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07101120
- Sponsor's protocol ID
- KH607-40101
- Status last verified
- Aug 2025
- First submitted
- 24 Jul 2025
- Last updated
- 28 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07101120
- Acronym / sponsor ID
- KH607-40101
- Conditions
- Major Depressive Disorder (MDD)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- Chengdu Kanghong Pharmaceutical Group Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 19 Mar 2025 (actual)
- Primary completion
- 9 Feb 2026 (actual)
- Study completion
- 9 Feb 2026 (actual)
- First posted
- 3 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Part A: KH607 | Experimental | Drug: KH607 tabletsParticipants receive KH607, 30 milligrams (mg), oral tablets, once daily for 14 days, as tolerated. |
| Part B: Placebo | Placebo comparator | Drug: placeboEligible participants receive matching placebo tabels once daily for 21 days. |
| Part B: KH607 30mg | Experimental | Drug: KH607 tabletsParticipants receive KH607, 30 milligrams (mg), oral tablets, once daily for 21 days. |
| Part B: KH607 20mg | Experimental | Drug: KH607 tabletsParticipants receive KH607, 20 milligrams (mg), oral tablets, once daily for 21 days. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KH607 tabletsoral 30mg , once daily for 14 days | Drug | Part A: KH607 |
| placebooral, once daily for 21 days | Drug | Part B: Placebo |
| KH607 tabletsoral 20mg, once daily for 21 days | Drug | Part B: KH607 20mg |
| KH607 tabletsoral 30mg, once daily for 21 days | Drug | Part B: KH607 30mg |
Primary outcome
Change From Baseline in the 17-item Hamilton Rating Scale for Depression (HAM-D17) Total Score at Day 15 - Part A
Time frame: Baseline to Day 15
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.
Change From Baseline in the 17-item Hamilton Rating Scale for Depression (HAM-D17) Total Score at Day 22 - Part B
Time frame: Baseline to Day 22
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.
18 secondary outcomes
Part A：Pharmacokinetic parameters of KH607 tablets (Cmax）
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Part A: Day 3,8,12,15,21,28
Percentage of Participants With Clinical Global Impression - Severity (CGI-S) Response - Part A
Time frame: Part A: Day 3,8,12,15,21,28
Percentage of Participants With Clinical Global Impression - Improvement (CGI-I) Response - Part A
Time frame: Part A: Day 3,8,12,15,21,28
Percentage of Participants With HAM-D Response - Part A
Time frame: Part A: Day 3,8,12,15,21,28
Percentage of Participants With HAM-D Remission - Part A
Time frame: Part A: Day 3,8,12,15,21,28
Change From Baseline in the 17-item Hamilton Rating Scale for Depression (HAM-D17) Total Score at all other time points - Part B
Time frame: Part B: Day 3,8,15,28,35,42
Change From Baseline in the Montgomery and Åsberg Depression Rating Scale (MADRS) Total Score at Day 15 and All Other Time Points - Part B
Time frame: Part B: Days3, 8, 15, 22,28,35 and 42
Change From Baseline in Hamilton Anxiety Rating Scale (HAM-A) Total Score at All Time Points - Part B
Time frame: Part B: Days3, 8, 15, 22,28,35 and 42
Percentage of Participants With Clinical Global Impression - Severity (CGI-S) Response - Part B
Time frame: Part B: Days3, 8, 15, 22,28,35 and 42
Percentage of Participants With Clinical Global Impression - Improvement (CGI-I) Response - Part B
Time frame: Part B: Days3, 8, 15, 22,28,35 and 42
Percentage of Participants With HAM-D Response - Part B
Time frame: Part B: Days3, 8, 15, 22,28,35 and 42
Percentage of Participants With HAM-D Remission - Part B
Time frame: Part B: Days3, 8, 15, 22,28,35 and 42
Part A：Pharmacokinetic parameters of KH607 tablets（Tmax）
Time frame: Part A: Day 1 to Day 21.
Part A：Pharmacokinetic parameters of KH607 tablets（AUC0-inf）
Time frame: Part A: Day 1 to Day 21.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2026.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing KH607 tablets in people with Major Depressive Disorder (MDD), run by Chengdu Kanghong Pharmaceutical Group Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in the 17-item Hamilton Rating Scale for Depression (HAM-D17) Total Score at Day 15 - Part A (time frame: Baseline to Day 15). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2026.