NCT06393673尚未招募2 期
A Randomized, Double-blind, Placebo-controlled, Phase 2 Study to Investigate the Efficacy and Safety of HS-10384 in Postmenopausal Women Suffering From Vasomotor Symptoms (Hot Flashes)
Hansoh BioMedical R&D Company1 个研究点 分布在 1 个国家目标入组 195 人开始时间: 2024年5月30日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 195
- 试验地点
- 1
- 主要终点
- Mean change in the severity of moderate to severe vasomotor symptoms from baseline to Week 4;
研究概览
简要总结
A randomized, double-blind, placebo-controlled phase 2 clinical study to evaluate the efficacy and safety of HS-10384 in postmenopausal women suffering from vasomotor symptoms.
详细描述
The phase 2 study is consisted with 2 doses. The aim is to detect the efficacy, safety, pharmacokinetics and pharmacodynamics characteristics of HS-10384 in participants with vasomotor symptoms.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 40 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women between 40 and 65 years old (including extremes);
- •The body mass index at screening is between 18.5~30 kg/m2 (including extremes)；
- •Subjects are postmenopausal women at screening as qualified by any of the following criteria: spontaneous amenorrhea ≥ 12 months, or spontaneous amenorrhea ≥ 6 months and FSH>40 IU/L (without other obvious pathological or physiological reasonsbefore screening), or documented surgical sterilization (such as hysterectomy, bilateral salpingectomy or bilateral oophorectomy, etc.);
- •At least 50 moderate to severe vasomotor symptoms per week (ie, 7 consecutive days), or 7 moderate to severe vasomotor symptoms per day (ie, 7 consecutive days) recorded in the daily diary during the screening period;
- •The blood pregnancy test of female subjects at baseline period is negative.
排除标准
- •Participants with disease history of unexplained uterine bleeding, endometrial hyperplasia, ovarian tumor, pituitary tumor, or other diseases evaluated by the principal investigator as not suitable for this study;
- •Have a history of migraine within 3 months before screening;
- •Uncontrolled hypertension and a systolic blood pressure ≥140 mmHg and/or a diastolic blood pressure ≥90 mmHg;
- •Previous or current history of a malignant tumor, except for basal cell carcinoma;
- •Participants with clinically significant diseases (such as neuropsychiatric system, cardiovascular system, urinary system, digestive system, respiratory system, skeletal muscle system, endocrine and metabolic system, blood system, skin disease, immune system, tumor, etc.) were evaluated by the researcher as not suitable for this study;
- •Within 4 weeks or 5 half-lives (whichever is longer) before taking drug, participants have taken hormonal treatment, hormonal contraceptive or other therapy due to VMS;
- •Within 4 weeks or 5 half-lives (whichever is longer) before screening, and during the whole study period, it is expected to take any medicine and health care products, including prescription drugs, immunomodulator or Chinese herbal medicine, etc.;
- •Participants have participated in any interventional study or taken study drugs within 3 months before screening;
- •Judged by the Investigator to be unsuited to participate in the study based on findings observed during physical examination, vital sign assessment, or 12-lead electrocardiogram (ECG), et al.;
- •Active liver disease or jaundice, or values of alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >2.5 x the upper limit of normal (ULN); or total bilirubin or direct bilirubin >1.5 x ULN;
- •Creatinine >1.5 x ULN; or estimated glomerular filtration rate (eGFR) using the CKD-EPI formula ≤59 mL/min/1.73 sqm at the screening visit;
研究组 & 干预措施
HS-10384 Dose 1
Experimental
Dose level 1 of HS-10384
干预措施: HS-10384 tablet Dose 1 (Drug)
HS-10384 Dose 1
Experimental
Dose level 1 of HS-10384
干预措施: HS-10384-matched placebo tablets (Drug)
HS-10384 Dose 2
Experimental
Dose level 2 of HS-10384
干预措施: HS-10384 tablet Dose 2 (Drug)
HS-10384 Dose 2
Experimental
Dose level 2 of HS-10384
干预措施: HS-10384-matched placebo tablets (Drug)
Placebo
Placebo Comparator
干预措施: HS-10384-matched placebo tablets (Drug)
结局指标
主要结局
Mean change in the severity of moderate to severe vasomotor symptoms from baseline to Week 4;
时间窗: Baseline to Week 4
Mean change in the frequency of moderate to severe vasomotor symptoms from baseline to Week 4;
时间窗: Baseline to Week 4
Mean change in the severity of moderate to severe vasomotor symptoms from baseline to Week 12.
时间窗: Baseline to Week 12
Mean change in the frequency of moderate to severe vasomotor symptoms from baseline to Week 12;
时间窗: Baseline to Week 12
次要结局
- Mean change in the hot flash score of moderate and severe vasomotor symptoms from baseline to each study week;(Baseline to Week 15)
- Number of participants with clinical laboratory abnormalities;(Baseline to Week 15)
- Number of participants with abnormalities of physical examinations(Baseline to Week 15)
- Change from baseline in ECG parameters(Baseline to Week 15)
- Change from baseline in plasma bone density marker concentrations(Baseline to Week 15)
- Change from baseline in Endometrial health assessment.(Baseline to Week 15)
- Number of participants with abnormalities of vital signs(Baseline to Week 15)
- Mean change in the severity of moderate and severe vasomotor symptoms from baseline to each study week;(Baseline to Week 15)
- Mean change in the frequency of moderate and severe vasomotor symptoms from baseline to each study week;(Baseline to Week 15)
- Mean percent reduction of 50% and 100% of moderate and severe vasomotor symptoms from baseline to each study week.(Baseline to Week 15)
- Incidence and severity of treatment-emergent adverse events;(Baseline to Week 15)
研究者
研究点 (1)
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