Psoriasis (PsO)Phase 1NCT07181343
A Drug-Drug Interaction Study Between HS-10374 Tablets and Drospirenone and Ethinyl Estradiol Tablets(Yasmin®)
A Phase 1 study testing HS-10374 tablets and Drospirenone and Ethinyl Estradiol tablets in people with Psoriasis (PsO), run by Hansoh BioMedical R&D Company at 1 site in China.
Trial summary
This trial is a single-center, open-label, fixed-sequence, self-controlled clinical study to evaluate Drug-Drug Interaction Between HS-10374 Tablets and Drospirenone and Ethinyl Estradiol Tablets (Yasmin®) Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Psoriasis (PsO)
- What is being tested?
- HS-10374 tablets and Drospirenone and Ethinyl Estradiol tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteChina
- Study dates
- 28 May 2025to 19 Aug 2025
- 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 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participants who sign the informed consent form before the trial, fully understand the trial content, procedures, and potential adverse reactions, and voluntarily commit to complying with all trial requirements.
- Healthy female participants aged 18 to 40 years (inclusive), with age calculated based on the date of signing the informed consent.
- Participants weighing ≥45 kg, with a body mass index (BMI) ranging from 19.0 to 26.0 kg/m² (inclusive). BMI = weight (kg) / height² (m²).
- Participants who agree to abstain from conception/donation of oocytes and practice complete abstinence from signing the informed consent until 40 days after the last dose.
Who cannot join
- Participants with clinically significant abnormalities in physical examination, vital signs, ECG, clinical laboratory tests, abdominal ultrasound, gynecological color ultrasound, or breast color Doppler ultrasound, as judged by the investigator.
- Positive results for any of the following during screening: Hepatitis B surface antigen (HBsAg), hepatitis C antibody, HIV antibody/p24 antigen, or Treponema pallidum antibody.
- Screening values exceeding 1.5×ULN for ALT, AST, or creatine kinase (CK), with clinical significance per investigator assessment.
- Screening serum creatinine >1×ULN, judged clinically significant by the investigator.
- QT interval prolongation on 12-lead ECG during screening (QTcF ≥470 ms).
- History of myopathy or rhabdomyolysis.
Show all 34Show fewer
- Severe pre-existing or current diseases affecting the nervous, psychiatric, digestive, circulatory, respiratory, urinary, cardiovascular, or immune systems-or any newly diagnosed condition prior to dosing-deemed by the investigator to contraindicate participation; including history of gastrointestinal disorders (e.g., gastric ulcer, reflux esophagitis).
- History of tuberculosis (TB).
- Current or previous history of: Venous thromboembolism (e.g., deep vein thrombosis, pulmonary embolism), Cerebrovascular disorders, Coronary artery disease, hypertension, Thrombogenic cardiac valvulopathy or rhythm disorders (e.g., subacute bacterial endocarditis with valvular disease, atrial fibrillation), Hereditary/acquired hypercoagulable states (e.g., Factor V Leiden mutation family history), Diabetes with vascular complications, Headaches with focal neurological symptoms, Migraine (with or without aura), Cholestatic jaundice and/or pruritus during prior hormone therapy.
- Current or previous renal impairment or adrenal insufficiency.
- Undiagnosed abnormal uterine/vaginal bleeding.
- Current or previous estrogen/progestin-sensitive cancers (e.g., breast cancer).
- Benign/malignant liver tumors or severe liver disease with safety risks per investigator judgment.
- Active/latent TB infection during screening, assessed by: T-SPOT.TB (interferon-gamma release assay),Chest X-ray. Exclusion if: Chest X-ray shows TB lesions OR T-SPOT.TB positive.
- Severe infections ≤30 days before screening (e.g., cellulitis, pneumonia, sepsis) OR herpes zoster within 3 months prior.
- Participants who have undergone surgery affecting drug absorption, distribution, metabolism, or excretion, deemed ineligible by the investigator.
- Individuals with a history of hypersensitivity or allergic predisposition (e.g., to pollen, ≥2 drugs/foods), or known allergy to: Active ingredients/excipients of the investigational products (Drospirenone and Ethinylestradiol Tablets \& HS-10374 Tablets), Other Janus Kinase (JAK) inhibitors.
- Participation in any other clinical trial involving investigational drugs/devices within 3 months prior to screening .
- Blood donation or significant blood loss (>400 mL) within 3 months before screening, or plans to donate blood during the trial or within 1 month after completion .
- Ingestion of grapefruit or grapefruit products within 48 hours before the first dose of investigational products .
- Excessive consumption of tea, coffee, or caffeine-containing beverages (>8 cups/day on average; 1 cup=200 mL) within 3 months prior to screening .
- Participants who smoked ≥1 cigarette/day within 3 months before screening, were unable to quit tobacco products during the trial, or tested positive for nicotine.
- Participants who drank alcohol frequently (>14 units/week, 1 unit =14 g alcohol) within 3 months before screening, couldn't stop using alcohol during the trial, or tested positive for alcohol in breath tests.
- Participants who used alcohol-containing products within 24 h before taking the test drug or had a positive alcohol breath test result.
- Participants with a history of drug abuse, dependence, or illicit drug use within 5 years before screening, or tested positive for drug abuse in urine tests.
- Participants who used drugs affecting liver metabolic enzymes (CYP3A, CYP1A2, CYP2D6, CYP2B6) or P-gp/BCRP activity, HIV/HCV protease inhibitors, non-nucleoside reverse transcriptase inhibitors, or hormonal drugs within 30 days before the first test drug dose.
- Participants who used long-acting estrogen/progestin injectables or implants within 12 months before the first dose, or transdermal contraceptives or intrauterine devices with hormones within 3 months before enrollment.
- Participants who used drugs altering gastric pH (e.g., rebamipide, omeprazole, lansoprazole, ranitidine, aluminum hydroxide) within 30 days before screening.
- Participants who used prescription drugs, OTC drugs, herbs, or health products (excluding local-acting topical agents) within 14 days before screening.
- Participants who used vaccines within 14 days before screening or planned to use them during or within two weeks after the trial.
- Participants who tested positive for pregnancy or were breastfeeding at screening.
- Participants who had unprotected sex within 14 days before screening.
- Participants unable to tolerate venipuncture/indwelling needle blood collection or with a history of fainting at the sight of blood.
- Participants unlikely to complete the trial for other reasons or deemed unsuitable by the investigator.
Trial locations and contacts
1 site in 1 country.
China1 site
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, 266001
About this study
Official title: A Study to Evaluate the Pharmacokinetics of Drospirenone and Ethinyl Estradiol Tablets (Yasmin®) When Co-administered With HS-10374 Tablets
This trial is a single-center, open-label, fixed-sequence, self-controlled clinical study to evaluate Drug-Drug Interaction Between HS-10374 Tablets and Drospirenone and Ethinyl Estradiol Tablets (Yasmin®)
Read the detailed description
This trial is a single-center, open-label, fixed-sequence, self-controlled clinical study. On Day 1 and Day 14, participants will orally take one tablet of Drospirenone and Ethinylestradiol Tablets (containing Drospirenone 3 mg and Ethinylestradiol 0.03 mg) under fasting conditions. From Day 8 to Day 19, participants will orally take HS-10374 Tablets 12 mg once daily under fasting conditions. Both drugs should be administered with approximately 240 mL of water.
- Conditions
- Psoriasis (PsO)
- Being tested
- HS-10374 tablets, Drospirenone and Ethinyl Estradiol tablets
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HS-10374 tabletsDrug
From Day 8 to Day 19, participants will orally take HS-10374 Tablets 12 mg（6 mg×2） once daily under fasting conditions
Drospirenone and Ethinyl Estradiol tabletsDrug
On Day 1 and Day 14, participants will orally take one tablet of Drospirenone and Ethinylestradiol Tablets under fasting conditions.
| Study group | Role | What they receive |
|---|---|---|
| HS-10374 + Drospirenone and Ethinyl Estradiol | Experimental | Not described Receives: Drug: HS-10374 tablets; Drug: Drospirenone and Ethinyl Estradiol tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of PK parameters of drospirenone and ethinylestradiol when used alone or in combination with HS-10374: Cmax
Maximum concentration
Measured: up to Day 20
Evaluation of PK parameters of drospirenone and ethinylestradiol when used alone or in combination with HS-10374: AUC0-t
Area under the plasma concentration-time curve fom time 0 to last time of quantifiable concentration
Measured: up to Day 20
Evaluation of PK parameters of drospirenone and ethinylestradiol when used alone or in combination with HS-10374: AUC0-24 h
Area under the plasma concentration-time curve fom time 0 to 24 h of quantifiable concentration
Measured: up to Day 20
Evaluation of PK parameters of drospirenone and ethinylestradiol when used alone or in combination with HS-10374: AUC0-∞
Area under the plasma concentration-time curve from time 0 extrapolated to infinite time
Measured: up to Day 20
Secondary outcomes (14)
Evaluation of PK parameters of drospirenone and ethinylestradiol when used alone or in combination with HS-10374: Tmax
Time to maximum concentration.
Measured: up to Day 20
Evaluation of PK parameters of drospirenone and ethinylestradiol when used alone or in combination with HS-10374: t1/2z
Elimination half-life
Measured: up to Day 20
Evaluation of PK parameters of drospirenone and ethinylestradiol when used alone or in combination with HS-10374: λz
Elimination rate constant.
Measured: up to Day 20
Evaluation of PK parameters of drospirenone and ethinylestradiol when used alone or in combination with HS-10374: CLz/F
Plasma clearance.
Measured: up to Day 20
Evaluation of PK parameters of drospirenone and ethinylestradiol when used alone or in combination with HS-10374: Vz/F
Apparent volume of distribution
Measured: up to Day 20
Evaluation of PK parameters of drospirenone and ethinylestradiol when used alone or in combination with HS-10374: MRT0-t
Mean Residence Time from 0-t
Measured: up to Day 20
Evaluation of PK parameters of drospirenone and ethinylestradiol when used alone or in combination with HS-10374: MRT0-∞
Mean Residence Time from 0-∞
Measured: up to Day 20
Evaluation of the pharmacokinetic characteristics of HS-10374 after multiple dosing：Cmax
Maximum concentration
Measured: up to Day 20
Evaluation of the pharmacokinetic characteristics of HS-10374 after multiple dosing: Cmin
Minimum concentration
Measured: up to Day 20
Evaluation of the pharmacokinetic characteristics of HS-10374 after multiple dosing: Cav
Steady State Concentration
Measured: up to Day 20
Evaluation of the pharmacokinetic characteristics of HS-10374 after multiple dosing: AUC0-24h
Area under the plasma concentration-time curve fom time 0 to 24 h of quantifiable concentration
Measured: up to Day 20
Evaluation of the pharmacokinetic characteristics of HS-10374 after multiple dosing: Tmax
Time to maximum concentration
Measured: up to Day 20
Evaluation of the pharmacokinetic characteristics of HS-10374 after multiple dosing: t1/2z
Elimination half-life
Measured: up to Day 20
Evaluation of the safety after single oral administration of HS-10374 tablets and drospirenone/ethinylestradiol tablets in healthy participants
Frequency of Adverse Events
Measured: through study completion, an average of 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2025
- Study start28 May 2025
- Primary completion17 Jun 2025
- Study completion19 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psoriasis (PsO)Studies of the same condition, open and under way.
- 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hansoh BioMedical R&D Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07181343
- Sponsor's protocol ID
- HS-10374-118
- Status last verified
- Sep 2025
- First submitted
- 20 Aug 2025
- Last updated
- 18 Sep 2025
- 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 18 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Evaluate the Pharmacokinetics of Drospirenone and Ethinyl Estradiol Tablets (Yasmin®) When Co-administered With HS-10374 Tablets
- ClinicalTrials.gov ID
- NCT07181343
- Acronym / sponsor ID
- HS-10374-118
- Conditions
- Psoriasis (PsO)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Hansoh BioMedical R&D CompanyIndustry (pharma, biotech, devices)
- Study start
- 28 May 2025 (actual)
- Primary completion
- 17 Jun 2025 (actual)
- Study completion
- 19 Aug 2025 (actual)
- First posted
- 18 Sep 2025 (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.
This trial is a single-center, open-label, fixed-sequence, self-controlled clinical study to evaluate Drug-Drug Interaction Between HS-10374 Tablets and Drospirenone and Ethinyl Estradiol Tablets (Yasmin®)
Detailed description
This trial is a single-center, open-label, fixed-sequence, self-controlled clinical study. On Day 1 and Day 14, participants will orally take one tablet of Drospirenone and Ethinylestradiol Tablets (containing Drospirenone 3 mg and Ethinylestradiol 0.03 mg) under fasting conditions. From Day 8 to Day 19, participants will orally take HS-10374 Tablets 12 mg once daily under fasting conditions. Both drugs should be administered with approximately 240 mL of water.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HS-10374 + Drospirenone and Ethinyl Estradiol | Experimental | Drug: HS-10374 tablets, Drug: Drospirenone and Ethinyl Estradiol tablets |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Participants who sign the informed consent form before the trial, fully understand the trial content, procedures, and potential adverse reactions, and voluntarily commit to complying with all trial requirements.
- Healthy female participants aged 18 to 40 years (inclusive), with age calculated based on the date of signing the informed consent.
- Participants weighing ≥45 kg, with a body mass index (BMI) ranging from 19.0 to 26.0 kg/m² (inclusive). BMI = weight (kg) / height² (m²).
- Participants who agree to abstain from conception/donation of oocytes and practice complete abstinence from signing the informed consent until 40 days after the last dose.
Key exclusion criteria (34 listed)
- Participants with clinically significant abnormalities in physical examination, vital signs, ECG, clinical laboratory tests, abdominal ultrasound, gynecological color ultrasound, or breast color Doppler ultrasound, as judged by the investigator.
- Positive results for any of the following during screening: Hepatitis B surface antigen (HBsAg), hepatitis C antibody, HIV antibody/p24 antigen, or Treponema pallidum antibody.
- Screening values exceeding 1.5×ULN for ALT, AST, or creatine kinase (CK), with clinical significance per investigator assessment.
- Screening serum creatinine >1×ULN, judged clinically significant by the investigator.
- QT interval prolongation on 12-lead ECG during screening (QTcF ≥470 ms).
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-10374 tabletsFrom Day 8 to Day 19, participants will orally take HS-10374 Tablets 12 mg（6 mg×2） once daily under fasting conditions | Drug | HS-10374 + Drospirenone and Ethinyl Estradiol |
| Drospirenone and Ethinyl Estradiol tabletsOn Day 1 and Day 14, participants will orally take one tablet of Drospirenone and Ethinylestradiol Tablets under fasting conditions. | Drug | HS-10374 + Drospirenone and Ethinyl Estradiol |
Primary outcome
Evaluation of PK parameters of drospirenone and ethinylestradiol when used alone or in combination with HS-10374: Cmax
Time frame: up to Day 20
Maximum concentration
Evaluation of PK parameters of drospirenone and ethinylestradiol when used alone or in combination with HS-10374: AUC0-t
Time frame: up to Day 20
Area under the plasma concentration-time curve fom time 0 to last time of quantifiable concentration
Evaluation of PK parameters of drospirenone and ethinylestradiol when used alone or in combination with HS-10374: AUC0-24 h
Time frame: up to Day 20
Area under the plasma concentration-time curve fom time 0 to 24 h of quantifiable concentration
Evaluation of PK parameters of drospirenone and ethinylestradiol when used alone or in combination with HS-10374: AUC0-∞
Time frame: up to Day 20
Area under the plasma concentration-time curve from time 0 extrapolated to infinite time
14 secondary outcomes
Evaluation of PK parameters of drospirenone and ethinylestradiol when used alone or in combination with HS-10374: Tmax
Time frame: up to Day 20
Evaluation of PK parameters of drospirenone and ethinylestradiol when used alone or in combination with HS-10374: t1/2z
Time frame: up to Day 20
Evaluation of PK parameters of drospirenone and ethinylestradiol when used alone or in combination with HS-10374: λz
Time frame: up to Day 20
Evaluation of PK parameters of drospirenone and ethinylestradiol when used alone or in combination with HS-10374: CLz/F
Time frame: up to Day 20
Evaluation of PK parameters of drospirenone and ethinylestradiol when used alone or in combination with HS-10374: Vz/F
Time frame: up to Day 20
Evaluation of PK parameters of drospirenone and ethinylestradiol when used alone or in combination with HS-10374: MRT0-t
Time frame: up to Day 20
Evaluation of PK parameters of drospirenone and ethinylestradiol when used alone or in combination with HS-10374: MRT0-∞
Time frame: up to Day 20
Evaluation of the pharmacokinetic characteristics of HS-10374 after multiple dosing：Cmax
Time frame: up to Day 20
Evaluation of the pharmacokinetic characteristics of HS-10374 after multiple dosing: Cmin
Time frame: up to Day 20
Evaluation of the pharmacokinetic characteristics of HS-10374 after multiple dosing: Cav
Time frame: up to Day 20
Evaluation of the pharmacokinetic characteristics of HS-10374 after multiple dosing: AUC0-24h
Time frame: up to Day 20
Evaluation of the pharmacokinetic characteristics of HS-10374 after multiple dosing: Tmax
Time frame: up to Day 20
Evaluation of the pharmacokinetic characteristics of HS-10374 after multiple dosing: t1/2z
Time frame: up to Day 20
Evaluation of the safety after single oral administration of HS-10374 tablets and drospirenone/ethinylestradiol tablets in healthy participants
Time frame: through study completion, an average of 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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-10374 tablets and Drospirenone and Ethinyl Estradiol tablets in people with Psoriasis (PsO), 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 4 inclusion and 34 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: finished, as of the sponsor's last update on 18 Sep 2025. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of PK parameters of drospirenone and ethinylestradiol when used alone or in combination with HS-10374: Cmax (time frame: up to Day 20). 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 18 Sep 2025.