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

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)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Vasomotor Symptoms
• Intervention / Treatment: Drug: HS-10384 tablet Dose 1; Drug: HS-10384-matched placebo tablets; Drug: HS-10384 tablet Dose 2

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 195
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Qi Yu, MD; Phone Number: (+86)13701227034; Email: yuqimd@163.com

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 100032
      • Chinese Academy of Medical Sciences (CAMS)Peking Union Medical College (PUMC)
      • Contact: Qi Yu, MD; Phone Number: (+86)13701227034; Email: yuqimd@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: HS-10384-matched placebo tablets; Administered orally QD
Experimental: HS-10384 Dose 1; Dose level 1 of HS-10384	Drug: HS-10384 tablet Dose 1; Administered orally QD; Drug: HS-10384-matched placebo tablets; Administered orally QD
Experimental: HS-10384 Dose 2; Dose level 2 of HS-10384	Drug: HS-10384-matched placebo tablets; Administered orally QD; Drug: HS-10384 tablet Dose 2; Administered orally QD

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Mean change in the frequency of moderate to severe vasomotor symptoms from baseline to Week 4;	Baseline to Week 4
Mean change in the frequency of moderate to severe vasomotor symptoms from baseline to Week 12;	Baseline to Week 12
Mean change in the severity of moderate to severe vasomotor symptoms from baseline to Week 4;	Baseline to Week 4
Mean change in the severity of moderate to severe vasomotor symptoms from baseline to Week 12.	Baseline to Week 12

Secondary Outcome Measures

Outcome Measure	Time Frame
Mean change in the frequency of moderate and severe vasomotor symptoms from baseline to each study week;	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 hot flash score 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
Number of participants with clinical laboratory abnormalities;	Baseline to Week 15
Number of participants with abnormalities of vital signs	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

Collaborators and Investigators

• Sponsor: Hansoh BioMedical R&D Company

Study record dates

Study Major Dates

• Study Start (Estimated): May 30, 2024
• Primary Completion (Estimated): June 30, 2025
• Study Completion (Estimated): September 30, 2025

Study Registration Dates

• First Submitted: April 27, 2024
• First Submitted That Met QC Criteria: April 27, 2024
• First Posted (Actual): May 1, 2024

Study Record Updates

• Last Update Posted (Actual): May 1, 2024
• Last Update Submitted That Met QC Criteria: April 27, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: postmenopausal women; Vasomotor symptoms; HS-10384
• Other Study ID Numbers: HS-10384-201

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No