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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A: KH607 | Experimental | Participants receive KH607, 30 milligrams (mg), oral tablets, once daily for 14 days, as tolerated. |
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| Part B: Placebo | Placebo Comparator | Eligible participants receive matching placebo tabels once daily for 21 days. |
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| Part B: KH607 30mg | Experimental | Participants receive KH607, 30 milligrams (mg), oral tablets, once daily for 21 days. |
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| Part B: KH607 20mg | Experimental | Participants receive KH607, 20 milligrams (mg), oral tablets, once daily for 21 days. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| KH607 tablets | Drug | oral 30mg , once daily for 14 days |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Part A：Pharmacokinetic parameters of KH607 tablets (Cmax） | Maximum observed plasma concentration following administration | 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 |
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Inclusion Criteria:
key exclusion criteria：
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Gang Wang, Medical Doctor | Contact | 86-010-58303063 | adgangwang@163.com | |
| Bing Bing Fu, Medical Doctor | Contact | 86-010-58303063 | fbbkidd@126.com |
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| placebo |
| Drug |
oral, once daily for 21 days |
|
| KH607 tablets | Drug | oral 20mg, once daily for 21 days |
|
| KH607 tablets | Drug | oral 30mg, once daily for 21 days |
|
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. |
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | Part B: Days3, 8, 15, 22,28,35 and 42 |
| Percentage of Participants With Clinical Global Impression - Severity (CGI-S) Response - Part B | Part B: Days3, 8, 15, 22,28,35 and 42 |
| Percentage of Participants With Clinical Global Impression - Improvement (CGI-I) Response - Part B | Part B: Days3, 8, 15, 22,28,35 and 42 |
| Percentage of Participants With HAM-D Response - Part B | Part B: Days3, 8, 15, 22,28,35 and 42 |
| Percentage of Participants With HAM-D Remission - Part B | 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 | 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. | Part A: Day 1 to Day 21. |
| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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