A Study to Find the Best Dose of HS-10384 to Treat Vasomotor Symptoms in Postmenopausal Women

Hansoh Pharma

Status and phase: Not yet enrolling; Phase 2

Conditions: Vasomotor Symptoms

Treatments: Drug: HS-10384-matched placebo tablets; Drug: HS-10384 tablet Dose 2; Drug: HS-10384 tablet Dose 1

Study type: Interventional

Funder types: Industry

Identifiers

NCT06393673

HS-10384-201

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 195 estimated patients

Sex: Female

Ages: 40 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Women between 40 and 65 years old (including extremes);
2. The body mass index at screening is between 18.5~30 kg/m2 (including extremes)；
3. 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.);
4. 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;
5. The blood pregnancy test of female subjects at baseline period is negative.

Exclusion criteria

1. 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;
2. Have a history of migraine within 3 months before screening;
3. Uncontrolled hypertension and a systolic blood pressure ≥140 mmHg and/or a diastolic blood pressure ≥90 mmHg;
4. Previous or current history of a malignant tumor, except for basal cell carcinoma;
5. 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;
6. 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;
7. 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.;
8. Participants have participated in any interventional study or taken study drugs within 3 months before screening;
9. 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.;
10. 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;
11. 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;

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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195 participants in 3 patient groups, including a placebo group

HS-10384 Dose 1

Experimental group

Description:

Dose level 1 of HS-10384

Treatment:

Drug: HS-10384 tablet Dose 1

Drug: HS-10384-matched placebo tablets

HS-10384 Dose 2

Experimental group

Description:

Dose level 2 of HS-10384

Treatment:

Drug: HS-10384 tablet Dose 2

Drug: HS-10384-matched placebo tablets

Placebo

Placebo Comparator group

Treatment:

Drug: HS-10384-matched placebo tablets