UnknownPhase 1

Study of HS-10384 in Participants of Chinese Postmenopausal Women

China48 participantsStarted 2023-11-12

Plain-language summary

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.

Who can participate

Age range40 Years – 65 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Subjects should fully understand the content, process and possible adverse reactions of the study, and voluntarily sign the informed consent form;
✓. Age between 40 and 65 years old (including the critical value);
✓. 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;
✓. 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.);
✓. 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);
✓. The blood pregnancy test of female subjects at baseline period is negative.

Exclusion criteria

✕. 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;
✕. Have a history of migraine within 3 months before screening;
✕. 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 2 weeks before screening, participants have suffered from VMS that inducing the interrupt of daily activities;
✕. Within 30 days before taking drug, participants have taken hormonal treatment 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.;
✕. Within 3 months before screening, participants have taken hormonal contraceptive;
✕. Participants have participated in any clinical study or taken study drugs within 3 months before screening;

What they're measuring

The incidence and severity of adverse events (AE), serious adverse events (SAE) and adverse events leading to withdrawal from the trial and the correlation with the investigational drug;

Timeframe: Day 1 to Day 21

Number of participants with clinical laboratory abnormalities

Timeframe: Day 1 to Day 21

Number of participants with abnormalities of vital signs

Timeframe: Day 1 to Day 21

Number of participants with abnormalities of physical examination

Timeframe: Day 1 to Day 21

Trial details

NCT IDNCT06122181

SponsorHansoh BioMedical R&D Company

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-06-30

Contact for this trial

Rong Li

(+86)010-82265571 roseli001@sina.com

View on ClinicalTrials.gov More Vasomotor Symptoms trials

Who can participate

Age range40 Years – 65 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Subjects should fully understand the content, process and possible adverse reactions of the study, and voluntarily sign the informed consent form;
✓. Age between 40 and 65 years old (including the critical value);
✓. 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;
✓. 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.);
✓. 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);
✓. The blood pregnancy test of female subjects at baseline period is negative.

Exclusion criteria

✕. 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;
✕. Have a history of migraine within 3 months before screening;
✕. 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 2 weeks before screening, participants have suffered from VMS that inducing the interrupt of daily activities;
✕. Within 30 days before taking drug, participants have taken hormonal treatment 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.;
✕. Within 3 months before screening, participants have taken hormonal contraceptive;
✕. Participants have participated in any clinical study or taken study drugs within 3 months before screening;

What they're measuring

The incidence and severity of adverse events (AE), serious adverse events (SAE) and adverse events leading to withdrawal from the trial and the correlation with the investigational drug;

Timeframe: Day 1 to Day 21

Number of participants with clinical laboratory abnormalities

Timeframe: Day 1 to Day 21

Number of participants with abnormalities of vital signs

Timeframe: Day 1 to Day 21

Number of participants with abnormalities of physical examination

Timeframe: Day 1 to Day 21