Clinical trial NCT06122181: Study of HS-10384 in Participants of Chinese Postmenopausal Women
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Vasomotor Symptoms
Keywords: HS-10384
multiple ascending dose
postmenopausal women
Lead sponsor: Hansoh BioMedical R&D Company
Sponsor class: INDUSTRY
First posted: 2023-11-08
Enrollment: 48
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief 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.

Detailed description: Phase Ib is consisted with 3\~4 multiple ascending doses.

Eligibility 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;

Primary outcomes:
measure: 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
measure: Number of participants with clinical laboratory abnormalities
timeFrame: Day 1 to Day 21
measure: Number of participants with abnormalities of vital signs
timeFrame: Day 1 to Day 21
measure: Number of participants with abnormalities of physical examination
timeFrame: Day 1 to Day 21
Secondary outcomes:
measure: Cmax
timeFrame: Day 1 to Day 13
measure: Tmax
timeFrame: Day 1 to Day 13
measure: AUC0-24
timeFrame: Day 1 to Day 13
measure: Css,max
timeFrame: Day 14 to Day 21
measure: Tss,max
timeFrame: Day 14 to Day 21
measure: Css,min
timeFrame: Day 14 to Day 21
measure: AUCss
timeFrame: Day 14 to Day 21
measure: RAC
timeFrame: Day 14 to Day 21
measure: Luteinizing hormone changes from baseline
timeFrame: Day 1 to Day 21
Other outcomes:
Locations:
city: Peking
country: China
facility: Peking University Third Hospital
state: Beijing
Study officials:
affiliation: Peking University Third Hospital
name: Rong Li, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Peking University Third Hospital
name: Dongyang Liu
role: PRINCIPAL_INVESTIGATOR
References: