Study of HS-10384 in Participants of Chinese Postmenopausal Women

Vasomotor Symptoms Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06122181
• Other study ID #: HS-10384-102
• Status: Recruiting
• Phase: Phase 1
• Start date: November 12, 2023
• Est. completion date: September 30, 2024

Study information

• Verified date: March 2024
• Source: Hansoh BioMedical R&D Company
• Contact: Rong Li
• Phone: (+86)010-82265571
• Email: roseli001[@]sina.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 48
• Est. completion date: September 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 40 Years to 65 Years

Eligibility

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;

Related Conditions & MeSH terms

• Vasomotor Symptoms

Intervention

Drug:
• HS-10384 tablets
Multiple dosing of HS-10384 orally in a fasting state
• HS-10384-matched placebo tablets
Multiple dosing of HS-10384-matched placebo orally in a fasting state

Locations

Country	Name	City	State
China	Peking University Third Hospital	Peking	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Hansoh BioMedical R&D Company

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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;		Day 1 to Day 21
Primary	Number of participants with clinical laboratory abnormalities	Clinical laboratory tests include blood routine, blood biochemistry, coagulation function, urine routine, thyroid function,etc.	Day 1 to Day 21
Primary	Number of participants with abnormalities of vital signs		Day 1 to Day 21
Primary	Number of participants with abnormalities of physical examination		Day 1 to Day 21
Secondary	Cmax	Maximum plasma concentration	Day 1 to Day 13
Secondary	Tmax	Time to Cmax	Day 1 to Day 13
Secondary	AUC0-24	Area under plasma concentration-time curve from time 0 to 24 h	Day 1 to Day 13
Secondary	Css,max	Maximum plasma concentration at steady state	Day 14 to Day 21
Secondary	Tss,max	Time to Cmax at steady state	Day 14 to Day 21
Secondary	Css,min	Minimum plasma concentration at steady state	Day 14 to Day 21
Secondary	AUCss	Area under plasma concentration-time curve in one dosing interval at steady state	Day 14 to Day 21
Secondary	RAC	Degree of accumulation after multiple doses	Day 14 to Day 21
Secondary	Luteinizing hormone changes from baseline		Day 1 to Day 21