PsoriasisPhase 1NCT06033742
A First in Human Study to Evaluate Safety, Tolerability, Pharmacology of HS-10374 in Healthy Subjects
A Phase 1 study testing HS-10374 tablets in people with Psoriasis, run by Jiangsu Hansoh Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
The purpose of this first-in-human study is to evaluate the safety, tolerability, and pharmacokinetics (PK) of HS-10374 in healthy subjects. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Psoriasis
- What is being tested?
- HS-10374 tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 84 participants
- Where
- 1 siteChina
- Study dates
- 13 Nov 2021to 24 Mar 2023
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male or female subjects between the ages of 18-45 years
- Have no reproductive potential; or agree to use a highly effective method of contraception, and refrain from donating sperm or eggs during the study period and for at least 6 months after last dosing
- Have signed the informed consent form approved by the IRB
Who cannot join
- Have a clinically significant infection currently or within past 30 days, or have a history of active tuberculosis; or have positive screening test for infectious disease, including tuberculosis, viral hepatitis, AIDS and syphilis
- Have a history of or current allergic disease
- Have a history of drug or alcohol abuse or currently positive test result(s) for alcohol or drugs of abuse
- Smokers smoked ≥5 cigarettes per day within past 3 months or have a positive test result for nicotine
- Clinically significant abnormal physical examination, vital signs, clinical laboratory values, ECGs or imaging tests
- Pregnant or breastfeeding female subjects
- Have received hormone-based contraceptives, drugs that prolong the QT interval, drugs that may cause drug interactions with investigational product, immunosuppressants, vaccines or other drugs within a specific period
Trial locations and contacts
1 site in 1 country.
China1 site
Huashan Hospital Affiliated to Fudan University
Shanghai, Shanghai Municipality, 200040
About this study
Official title: A Phase 1, Randomized, Double-blind, Placebo-controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of HS-10374 in Healthy Subjects
The purpose of this first-in-human study is to evaluate the safety, tolerability, and pharmacokinetics (PK) of HS-10374 in healthy subjects.
- Conditions
- Psoriasis
- Being tested
- HS-10374 tablets, HS-10374-matched placebo 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
Single or multiple dosing of HS-10374 orally in a fasting state
HS-10374-matched placebo tabletsDrug
Single or multiple dosing of HS-10374-matched placebo orally in a fasting state
| Study group | Role | What they receive |
|---|---|---|
| HS-10374 | Experimental | Single and multiple ascending doses of HS-10374 orally Receives: Drug: HS-10374 tablets |
| Placebo | Placebo comparator | Single and multiple ascending doses of HS-10374-matched placebo orally Receives: Drug: HS-10374-matched placebo tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence, severity and association with the study drug of adverse events (AEs), serious AEs (SAEs), and AEs leading to discontinuation
Measured: Day 1 up to Day 12 (SAD), Day 1 up to Day 42 (MAD)
Number of participants with clinical laboratory abnormalities
Clinical laboratory tests include hematology, urinalysis, stool analysis, blood chemistry, coagulation testing, Cystatin C, urine β2-microglobulin, erythrocyte sedimentation rate, C-reactive protein, etc.
Measured: Day 1 up to Day 12 (SAD), Day 1 up to Day 42 (MAD)
Number of participants with abnormalities of vital signs
Vital sign measured include blood pressure, pulse rate, temperature, and respiration rate.
Measured: Day 1 up to Day 12 (SAD), Day 1 up to Day 42 (MAD)
Number of participants with abnormalities of physical examination
Physical examination includes assessments of general appearance, skin, lymph nodes, head, neck, lung, heart, abdomen, spine, extremities, nervous system, etc.
Measured: Day 1 up to Day 12 (SAD), Day 1 up to Day 42 (MAD)
Number of participants with abnormalities of electrocardiogram (ECG) parameters
ECG parameters include heart rate, PR interval, RR interval, QRS duration, QTcF interval.
Measured: Day 1 up to Day 12 (SAD), Day 1 up to Day 42 (MAD)
Secondary outcomes (7)
Cmax
Maximum plasma concentration
Measured: Day 1 up to Day 6 (SAD), Day 1 up to Day 19 (MAD)
Tmax
Time to reach Cmax
Measured: Day 1 up to Day 6 (SAD), Day 1 up to Day 19 (MAD)
AUC
Area under the plasma concentration-time curve
Measured: Day 1 up to Day 6 (SAD), Day 1 up to Day 19 (MAD)
t½
Terminal half-life
Measured: Day 1 up to Day 6 (SAD), Day 1 up to Day 19 (MAD)
CL/F
Apparent clearance
Measured: Day 1 up to Day 6 (SAD), Day 1 up to Day 19 (MAD)
Vz/F
Apparent volume of distribution
Measured: Day 1 up to Day 6 (SAD), Day 1 up to Day 19 (MAD)
Rac
Accumulation ratio
Measured: Day 1 up to Day 6 (SAD), Day 1 up to Day 19 (MAD)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2023
- Study start13 Nov 2021
- Primary completion24 Mar 2023
- Study completion24 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsoriasisStudies of the same condition, open and under way.
- More trials run by Jiangsu Hansoh Pharmaceutical Co., Ltd.The 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
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jiangsu Hansoh Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jing Zhang, PhD, Principal investigator, Huashan HospitalJinhua Xu, MD, Principal investigator, Huashan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06033742
- Sponsor's protocol ID
- HS-10374-101
- Status last verified
- Aug 2023
- First submitted
- 24 Aug 2023
- Last updated
- 13 Sep 2023
- 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 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Double-blind, Placebo-controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of HS-10374 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT06033742
- Acronym / sponsor ID
- HS-10374-101
- Conditions
- Psoriasis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Jiangsu Hansoh Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 13 Nov 2021 (actual)
- Primary completion
- 24 Mar 2023 (actual)
- Study completion
- 24 Mar 2023 (actual)
- First posted
- 13 Sep 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.
The purpose of this first-in-human study is to evaluate the safety, tolerability, and pharmacokinetics (PK) of HS-10374 in healthy subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HS-10374 | Experimental | Drug: HS-10374 tabletsSingle and multiple ascending doses of HS-10374 orally |
| Placebo | Placebo comparator | Drug: HS-10374-matched placebo tabletsSingle and multiple ascending doses of HS-10374-matched placebo orally |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy male or female subjects between the ages of 18-45 years
- Have no reproductive potential; or agree to use a highly effective method of contraception, and refrain from donating sperm or eggs during the study period and for at least 6 months after last dosing
- Have signed the informed consent form approved by the IRB
Key exclusion criteria (7 listed)
- Have a clinically significant infection currently or within past 30 days, or have a history of active tuberculosis; or have positive screening test for infectious disease, including tuberculosis, viral hepatitis, AIDS and syphilis
- Have a history of or current allergic disease
- Have a history of drug or alcohol abuse or currently positive test result(s) for alcohol or drugs of abuse
- Smokers smoked ≥5 cigarettes per day within past 3 months or have a positive test result for nicotine
- Clinically significant abnormal physical examination, vital signs, clinical laboratory values, ECGs or imaging tests
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 tabletsSingle or multiple dosing of HS-10374 orally in a fasting state | Drug | HS-10374 |
| HS-10374-matched placebo tabletsSingle or multiple dosing of HS-10374-matched placebo orally in a fasting state | Drug | Placebo |
Primary outcome
Incidence, severity and association with the study drug of adverse events (AEs), serious AEs (SAEs), and AEs leading to discontinuation
Time frame: Day 1 up to Day 12 (SAD), Day 1 up to Day 42 (MAD)
Number of participants with clinical laboratory abnormalities
Time frame: Day 1 up to Day 12 (SAD), Day 1 up to Day 42 (MAD)
Clinical laboratory tests include hematology, urinalysis, stool analysis, blood chemistry, coagulation testing, Cystatin C, urine β2-microglobulin, erythrocyte sedimentation rate, C-reactive protein, etc.
Number of participants with abnormalities of vital signs
Time frame: Day 1 up to Day 12 (SAD), Day 1 up to Day 42 (MAD)
Vital sign measured include blood pressure, pulse rate, temperature, and respiration rate.
Number of participants with abnormalities of physical examination
Time frame: Day 1 up to Day 12 (SAD), Day 1 up to Day 42 (MAD)
Physical examination includes assessments of general appearance, skin, lymph nodes, head, neck, lung, heart, abdomen, spine, extremities, nervous system, etc.
Number of participants with abnormalities of electrocardiogram (ECG) parameters
Time frame: Day 1 up to Day 12 (SAD), Day 1 up to Day 42 (MAD)
ECG parameters include heart rate, PR interval, RR interval, QRS duration, QTcF interval.
7 secondary outcomes
Cmax
Time frame: Day 1 up to Day 6 (SAD), Day 1 up to Day 19 (MAD)
Tmax
Time frame: Day 1 up to Day 6 (SAD), Day 1 up to Day 19 (MAD)
AUC
Time frame: Day 1 up to Day 6 (SAD), Day 1 up to Day 19 (MAD)
t½
Time frame: Day 1 up to Day 6 (SAD), Day 1 up to Day 19 (MAD)
CL/F
Time frame: Day 1 up to Day 6 (SAD), Day 1 up to Day 19 (MAD)
Vz/F
Time frame: Day 1 up to Day 6 (SAD), Day 1 up to Day 19 (MAD)
Rac
Time frame: Day 1 up to Day 6 (SAD), Day 1 up to Day 19 (MAD)
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 13 Sep 2023.
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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.
Jing Zhang, PhD principal investigator
Huashan Hospital
Jinhua Xu, MD principal investigator
Huashan 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-10374 tablets in people with Psoriasis, run by Jiangsu Hansoh Pharmaceutical Co., Ltd. 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 3 inclusion and 7 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 13 Sep 2023. 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?
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?
Incidence, severity and association with the study drug of adverse events (AEs), serious AEs (SAEs), and AEs leading to discontinuation (time frame: Day 1 up to Day 12 (SAD), Day 1 up to Day 42 (MAD)). The study lists 5 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 Sep 2023.