Evaluating HS-10384 for treating vasomotor symptoms in postmenopausal women
A Randomized, Double-blind, Placebo-controlled Phase Ib Clinical Study to Evaluate the Safety, Tolerability and Pharmacokinetics Characteristics of HS-10384 in Chinese Postmenopausal Women
This study is testing a new medication called HS-10384 to see if it can help relieve hot flashes and other symptoms in postmenopausal women.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 48 (estimated) |
| Ages | 40 Years to 65 Years |
| Sex | Female |
| Sponsor | Hansoh BioMedical R&D Company Industry-sponsored |
| Locations | 1 site (Peking, Beijing) |
| Trial ID | NCT06122181 on ClinicalTrials.gov |
What this trial studies
This clinical trial is a randomized, double-blind, placebo-controlled phase Ib study designed to assess the safety, tolerability, and pharmacokinetics of HS-10384 in Chinese postmenopausal women. The study will involve multiple ascending doses of HS-10384 tablets compared to matched placebo tablets. Participants will be closely monitored for adverse reactions and overall response to the treatment. The trial aims to gather important data that could inform future studies and potential therapeutic use of HS-10384.
Who should consider this trial
Good fit: Ideal candidates for this study are Chinese postmenopausal women aged 40 to 65 with a BMI between 19 and 28.
Not a fit: Patients who are not postmenopausal or have significant health issues that could interfere with the study may not benefit from this trial.
Why it matters
Potential benefit: If successful, this study could provide a new treatment option for managing vasomotor symptoms in postmenopausal women.
How similar studies have performed: While this approach is novel in the context of HS-10384, similar studies have shown promise in evaluating treatments for vasomotor symptoms.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Subjects should fully understand the content, process and possible adverse reactions of the study, and voluntarily sign the informed consent form; 2. Age between 40 and 65 years old (including the critical value); 3. The body mass index (BMI=body weight \[kg\]/height2 \[m2\]) at screening is 19\~28 kg/m2 (including the critical value of 19), and the weight is ≥ 40 kg; 4. 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.); 5. From 48 hours before taking drug to the end of the study, subjects should avoid taking tobacco products, alcohol and other foods or drinks that might affect drug metabolism (such as coffee, tea, cola or other caffeinated drinks); 6. The blood pregnancy test of female subjects at baseline period is negative. Exclusion Criteria: 1. Participants with disease history of uterine bleeding, uterine 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. 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; 4. Within 2 weeks before screening, participants have suffered from VMS that inducing the interrupt of daily activities; 5. Within 30 days before taking drug, participants have taken hormonal treatment or other therapy due to VMS; 6. 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.; 7. Within 3 months before screening, participants have taken hormonal contraceptive; 8. Participants have participated in any clinical study or taken study drugs within 3 months before screening;
Where this trial is running
Peking, Beijing
- Peking University Third Hospital — Peking, Beijing, China (Recruiting)
Study contacts
- Principal investigator: Rong Li, PhD — Peking University Third Hospital
- Study coordinator: Rong Li
- Email: roseli001@sina.com
- Phone: (+86)010-82265571
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.