Study of HS-10384 in Participants of Chinese Postmenopausal Women

Hansoh Pharma

Status and phase: Enrolling; Phase 1

Conditions: Vasomotor Symptoms

Treatments: Drug: HS-10384 tablets; Drug: HS-10384-matched placebo tablets

Study type: Interventional

Funder types: Industry

Identifiers

NCT06122181

HS-10384-102

Details and patient eligibility

About

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.

Full description

Phase Ib is consisted with 3~4 multiple ascending doses.

Enrollment: 48 estimated patients

Sex: Female

Ages: 40 to 65 years old

Volunteers: Accepts Healthy Volunteers

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;

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

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48 participants in 2 patient groups, including a placebo group

HS-10384

Experimental group

Description:

Multiple ascending doses of HS-10384 orally

Treatment:

Drug: HS-10384 tablets

Placebo

Placebo Comparator group

Description:

Multiple ascending doses of HS-10384 placebo orally

Treatment:

Drug: HS-10384-matched placebo tablets