Study of HS-10384 in Participants of Chinese Postmenopausal Women

NCT06122181 | Recruiting Phase 1

• 1 other identifier: HS-10384-102
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Vasomotor Symptoms

Keywords

HS-10384; multiple ascending dose; postmenopausal women

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (9)

• Cmax

  Day 1 to Day 13

• Tmax

  Day 1 to Day 13

• AUC0-24

  Day 1 to Day 13

• Css,max

  Day 14 to Day 21

• Tss,max

  Day 14 to Day 21

Study Arms (2)

HS-10384

EXPERIMENTAL

Multiple ascending doses of HS-10384 orally

Drug: HS-10384 tablets

Placebo

PLACEBO COMPARATOR

Multiple ascending doses of HS-10384 placebo orally

Drug: HS-10384-matched placebo tablets

Interventions

HS-10384 tablets DRUG

Multiple dosing of HS-10384 orally in a fasting state

HS-10384

HS-10384-matched placebo tablets DRUG

Multiple dosing of HS-10384-matched placebo orally in a fasting state

Placebo

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Hansoh BioMedical R&D Company: lead

Study Sites (1)

Peking University Third Hospital

Beijing, Beijing Municipality, 100000, China

RECRUITING

Study Officials

• Rong Li, PhD

  Peking University Third Hospital

  PRINCIPAL INVESTIGATOR

• Dongyang Liu

  Peking University Third Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rong Li

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 3, 2023
• First Posted: November 8, 2023
• Study Start: November 12, 2023
• Primary Completion: June 30, 2024
• Study Completion: September 30, 2024
• Last Updated: March 13, 2024

Record last verified: 2024-03

Locations

CN (1)