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
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 126
- 试验地点
- 1
- 主要终点
- Change From Baseline in the 17-item Hamilton Rating Scale for Depression (HAM-D17) Total Score at Day 15 - Part A
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •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.
排除标准
- •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
- •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.
研究组 & 干预措施
Part B: Placebo
Eligible participants receive matching placebo tabels once daily for 21 days.
干预措施: placebo (Drug)
Part B: KH607 30mg
Participants receive KH607, 30 milligrams (mg), oral tablets, once daily for 21 days.
干预措施: KH607 tablets (Drug)
Part B: KH607 20mg
Participants receive KH607, 20 milligrams (mg), oral tablets, once daily for 21 days.
干预措施: KH607 tablets (Drug)
Part A: KH607
Participants receive KH607, 30 milligrams (mg), oral tablets, once daily for 14 days, as tolerated.
干预措施: KH607 tablets (Drug)
结局指标
主要结局
Change From Baseline in the 17-item Hamilton Rating Scale for Depression (HAM-D17) Total Score at Day 15 - Part A
时间窗: 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
时间窗: 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.
次要结局
- Percentage of Participants With HAM-D Remission - Part A(Part A: Day 3,8,12,15,21,28)
- Part A：Pharmacokinetic parameters of KH607 tablets (Cmax）(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(Part A: Day 15)
- Percentage of Participants With Clinical Global Impression - Improvement (CGI-I) Response - Part A(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 A(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(Part A: Day 3,8,12,15,21,28)
- Percentage of Participants With HAM-D Response - Part A(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(Part A: Day 3,8,12,15,21,28)
- Percentage of Participants With Clinical Global Impression - Severity (CGI-S) Response - Part A(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(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(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(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）(Part A: Day 1 to Day 21.)
- Part A：Pharmacokinetic parameters of KH607 tablets（AUC0-inf）(Part A: Day 1 to Day 21.)