Study of HS-10384 in Participants of Chinese 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

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 Overview

• Status: Recruiting
• Conditions: Vasomotor Symptoms
• Intervention / Treatment: Drug: HS-10384 tablets; Drug: HS-10384-matched placebo tablets

Detailed Description

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

• Study Type: Interventional
• Enrollment (Estimated): 48
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Rong Li; Phone Number: (+86)010-82265571; Email: roseli001@sina.com

Study Locations

• China
  • Beijing
    • Peking, Beijing, China, 100000
      • Recruiting
      • Peking University Third Hospital
      • Principal Investigator: Dongyang Liu
      • Contact: Rong Li, PhD; Email: roseli001@sina.com
      • Principal Investigator: Rong Li

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HS-10384; Multiple ascending doses of HS-10384 orally	Drug: HS-10384 tablets; Multiple dosing of HS-10384 orally in a fasting state
Placebo Comparator: Placebo; Multiple ascending doses of HS-10384 placebo orally	Drug: HS-10384-matched placebo tablets; Multiple dosing of HS-10384-matched placebo orally in a fasting state

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Number of participants with abnormalities of vital signs		Day 1 to Day 21
Number of participants with abnormalities of physical examination		Day 1 to Day 21

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cmax	Maximum plasma concentration	Day 1 to Day 13
Tmax	Time to Cmax	Day 1 to Day 13
AUC0-24	Area under plasma concentration-time curve from time 0 to 24 h	Day 1 to Day 13
Css,max	Maximum plasma concentration at steady state	Day 14 to Day 21
Tss,max	Time to Cmax at steady state	Day 14 to Day 21
Css,min	Minimum plasma concentration at steady state	Day 14 to Day 21
AUCss	Area under plasma concentration-time curve in one dosing interval at steady state	Day 14 to Day 21
RAC	Degree of accumulation after multiple doses	Day 14 to Day 21
Luteinizing hormone changes from baseline		Day 1 to Day 21

Collaborators and Investigators

• Sponsor: Hansoh BioMedical R&D Company
• Investigators: Principal Investigator: Rong Li, PhD, Peking University Third Hospital; Principal Investigator: Dongyang Liu, Peking University Third Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 12, 2023
• Primary Completion (Estimated): June 30, 2024
• Study Completion (Estimated): September 30, 2024

Study Registration Dates

• First Submitted: November 3, 2023
• First Submitted That Met QC Criteria: November 7, 2023
• First Posted (Actual): November 8, 2023

Study Record Updates

• Last Update Posted (Actual): March 13, 2024
• Last Update Submitted That Met QC Criteria: March 11, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: postmenopausal women; multiple ascending dose; HS-10384
• Other Study ID Numbers: HS-10384-102

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No