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

NCT06393673 | Not Yet Recruiting Phase 2

• 1 other identifier: HS-10384-201
• Study Type: interventional
• Target: 195
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Vasomotor Symptoms

Keywords

HS-10384; Vasomotor symptoms; postmenopausal women

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (11)

• 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

Study Arms (3)

HS-10384 Dose 1

EXPERIMENTAL

Dose level 1 of HS-10384

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

HS-10384 Dose 2

EXPERIMENTAL

Dose level 2 of HS-10384

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

Placebo

PLACEBO COMPARATOR

Drug: HS-10384-matched placebo tablets

Interventions

HS-10384 tablet Dose 1 DRUG

Administered orally QD

HS-10384 Dose 1

HS-10384 tablet Dose 2 DRUG

Administered orally QD

HS-10384 Dose 2

HS-10384-matched placebo tablets DRUG

Administered orally QD

HS-10384 Dose 1; HS-10384 Dose 2; Placebo

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Hansoh BioMedical R&D Company: lead

Study Sites (1)

Chinese Academy of Medical Sciences (CAMS)Peking Union Medical College (PUMC)

Shanghai, Shanghai Municipality, 100032, China

Location

Central Study Contacts

Qi Yu, MD

CONTACT

(+86)13701227034; yuqimd@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 27, 2024
• First Posted: May 1, 2024
• Study Start: May 30, 2024
• Primary Completion: June 30, 2025
• Study Completion: September 30, 2025
• Last Updated: May 1, 2024

Record last verified: 2024-04

Locations

CN (1)