Vasomotor SymptomsPhase 1NCT06122181
Study of HS-10384 in Participants of Chinese Postmenopausal Women
A Phase 1 study testing HS-10384 tablets in people with Vasomotor Symptoms, run by Hansoh BioMedical R&D Company at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 40 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Vasomotor Symptoms
- What is being tested?
- HS-10384 tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteChina
- Study dates
- 12 Nov 2023to 30 Sep 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking University Third Hospital
Beijing, Beijing Municipality, 100000
Rong Li, PhD, roseli001@sina.com
Rong Li
About this study
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
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.
Read the detailed description
Phase Ib is consisted with 3~4 multiple ascending doses.
- Conditions
- Vasomotor Symptoms
- Being tested
- HS-10384 tablets, HS-10384-matched placebo tablets
- Keywords
- HS-10384, multiple ascending dose, postmenopausal women
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HS-10384 tabletsDrug
Multiple dosing of HS-10384 orally in a fasting state
HS-10384-matched placebo tabletsDrug
Multiple dosing of HS-10384-matched placebo orally in a fasting state
| Study group | Role | What they receive |
|---|---|---|
| HS-10384 | Experimental | Multiple ascending doses of HS-10384 orally Receives: Drug: HS-10384 tablets |
| Placebo | Placebo comparator | Multiple ascending doses of HS-10384 placebo orally Receives: Drug: HS-10384-matched placebo tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
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;
Measured: 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.
Measured: Day 1 to Day 21
Number of participants with abnormalities of vital signs
Measured: Day 1 to Day 21
Number of participants with abnormalities of physical examination
Measured: Day 1 to Day 21
Secondary outcomes (9)
Cmax
Maximum plasma concentration
Measured: Day 1 to Day 13
Tmax
Time to Cmax
Measured: Day 1 to Day 13
AUC0-24
Area under plasma concentration-time curve from time 0 to 24 h
Measured: Day 1 to Day 13
Css,max
Maximum plasma concentration at steady state
Measured: Day 14 to Day 21
Tss,max
Time to Cmax at steady state
Measured: Day 14 to Day 21
Css,min
Minimum plasma concentration at steady state
Measured: Day 14 to Day 21
AUCss
Area under plasma concentration-time curve in one dosing interval at steady state
Measured: Day 14 to Day 21
RAC
Degree of accumulation after multiple doses
Measured: Day 14 to Day 21
Luteinizing hormone changes from baseline
Measured: Day 1 to Day 21
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2023
- Study start12 Nov 2023
- Primary completion30 Jun 2024 (estimated)
- Study completion30 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vasomotor SymptomsStudies of the same condition, open and under way.
- More trials run by Hansoh BioMedical R&D CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hansoh BioMedical R&D Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Rong Li, PhD, Principal investigator, Peking University Third HospitalDongyang Liu, Principal investigator, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06122181
- Sponsor's protocol ID
- HS-10384-102
- Status last verified
- Mar 2024
- First submitted
- 3 Nov 2023
- Last updated
- 13 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06122181
- Acronym / sponsor ID
- HS-10384-102
- Conditions
- Vasomotor Symptoms
- Keywords
- HS-10384, multiple ascending dose, postmenopausal women
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Hansoh BioMedical R&D CompanyIndustry (pharma, biotech, devices)
- Study start
- 12 Nov 2023 (actual)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 30 Sep 2024 (estimated)
- First posted
- 8 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HS-10384 | Experimental | Drug: HS-10384 tabletsMultiple ascending doses of HS-10384 orally |
| Placebo | Placebo comparator | Drug: HS-10384-matched placebo tabletsMultiple ascending doses of HS-10384 placebo orally |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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);
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HS-10384 tabletsMultiple dosing of HS-10384 orally in a fasting state | Drug | HS-10384 |
| HS-10384-matched placebo tabletsMultiple dosing of HS-10384-matched placebo orally in a fasting state | Drug | Placebo |
Primary outcome
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;
Time frame: Day 1 to Day 21
Number of participants with clinical laboratory abnormalities
Time frame: Day 1 to Day 21
Clinical laboratory tests include blood routine, blood biochemistry, coagulation function, urine routine, thyroid function,etc.
Number of participants with abnormalities of vital signs
Time frame: Day 1 to Day 21
Number of participants with abnormalities of physical examination
Time frame: Day 1 to Day 21
9 secondary outcomes
Cmax
Time frame: Day 1 to Day 13
Tmax
Time frame: Day 1 to Day 13
AUC0-24
Time frame: Day 1 to Day 13
Css,max
Time frame: Day 14 to Day 21
Tss,max
Time frame: Day 14 to Day 21
Css,min
Time frame: Day 14 to Day 21
AUCss
Time frame: Day 14 to Day 21
RAC
Time frame: Day 14 to Day 21
Luteinizing hormone changes from baseline
Time frame: Day 1 to Day 21
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rong Li, PhD principal investigator
Peking University Third Hospital
Dongyang Liu principal investigator
Peking University Third Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing HS-10384 tablets in people with Vasomotor Symptoms, run by Hansoh BioMedical R&D Company at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rong Li ((+86)010-82265571, roseli001@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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; (time frame: Day 1 to Day 21). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2024.