Psoriasis VulgarisPhase 1NCT07802964
A Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Pharmacodynamics of HRS-4139 in Healthy Participants
A Phase 1 study testing HRS-4139 Tablet in people with Psoriasis Vulgaris, run by Fujian Shengdi Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
This Phase I clinical study aims to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single oral dose of HRS-4139 in healthy participants. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Psoriasis Vulgaris
- What is being tested?
- HRS-4139 Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 21 Sep 2026to Apr 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participants who understand the specific procedures of the trial, voluntarily agree to participate in this trial, and provide written informed consent.
- Participants aged 18 to 55 years (inclusive) at screening.
- Male body weight ≥ 50 kg, female body weight ≥ 45 kg, and body mass index (BMI) between 18.0 and 26.0 kg/m² (inclusive).
- Participants who are able to communicate effectively with the investigator, fully understand and comply with all requirements of the trial protocol.
Who cannot join
- Participants with any disease of the circulatory, endocrine, neurological, digestive, respiratory, hematologic, immunologic, psychiatric, or metabolic systems, or any other condition that may interfere with the trial results.
- Participants with a history of malignancy.
- Participants with a history of risk factors for Torsades de Pointes (e.g., heart failure, hypokalemia), or with short QT syndrome or long QT syndrome, or with a family history in first-degree relatives of unexplained sudden death, drowning, or sudden infant death syndrome (SIDS) occurring at ≤ 40 years of age.
- Participants who have had an opportunistic infection within 6 months prior to screening; or who have a known history of recurrent or chronic infections, or who have had chronic or recurrent sinusitis, tonsillitis, urinary tract infections, prostatitis, enteritis, etc.
- Participants who have had an acute infection with systemic symptoms requiring systemic anti-infective therapy (intravenous or oral) within 4 weeks prior to screening.
- Participants who have participated in any clinical trial of a drug or medical device within 3 months prior to screening, where participation is defined as having signed the informed consent and having received the investigational drug or medical device; or Participants who are still within the follow-up period of any clinical study or within 5 elimination half-lives of the study drug at the time of screening, whichever is longer.
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- Participants who have used any medication (including prescription drugs, over-the-counter medications, Chinese herbal medicines, dietary supplements, etc.) within 2 weeks or within 5 elimination half-lives (whichever is longer) prior to the administration of the study drug; or Participants who plan to use any other medication during the study period.
- Participants who have received a live (attenuated) vaccine within 1 month prior to screening or plan to receive such a vaccine during the trial period, with the exception of influenza vaccination.
- Participants who have experienced severe trauma or undergone major surgery within 6 months prior to screening, or who plan to undergo surgery during the trial period.
- Participants who have donated blood or experienced significant blood loss (≥ 400 mL) within 1 month prior to screening, or who have received a blood transfusion within 2 months prior to screening.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Xiangya Hospital of Central South University
Changsha, Hunan, 410008
Gan Zhou, +86-0731-89753401, Zhougan77@163.com
Gan Zhou
About this study
Official title: A Randomized, Double-blind, Dose-escalation Phase I Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Pharmacodynamics of a Single Oral Dose of HRS-4139 in Healthy Participants
This Phase I clinical study aims to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single oral dose of HRS-4139 in healthy participants.
- Conditions
- Psoriasis Vulgaris
- Being tested
- HRS-4139 Tablet, HRS-4139 Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HRS-4139 TabletDrug
HRS-4139 tablet.
HRS-4139 PlaceboDrug
HRS-4139 placebo.
| Study group | Role | What they receive |
|---|---|---|
| HRS-4139 tablet group | Experimental | Not described Receives: Drug: HRS-4139 Tablet |
| HRS-4139 placebo group | Placebo comparator | Not described Receives: Drug: HRS-4139 Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events (AEs)
Measured: Evaluation was performed up to Day 36 or Day 72.
Serious Adverse events (SAEs)
Measured: Evaluation was performed up to Day 36 or Day 72.
Secondary outcomes (9)
Plasma concentration of HRS-4139 in healthy participants
Measured: Evaluation was performed up to Day 36 or Day 72.
Peak concentration (Cmax)
PK parameter.
Measured: Evaluation was performed up to Day 36 or Day 72.
Time to peak concentration (Tmax)
PK parameter.
Measured: Evaluation was performed up to Day 36 or Day 72.
Area under the concentration-time curve from time 0 to the last quantifiable time point (AUC0-last)
PK parameter.
Measured: Evaluation was performed up to Day 36 or Day 72.
Area under the concentration-time curve from time 0 to infinity (AUC0-inf)
PK parameter.
Measured: Evaluation was performed up to Day 36 or Day 72.
Elimination half-life (t1/2)
PK parameter.
Measured: Evaluation was performed up to Day 36 or Day 72.
Apparent clearance (CL/F)
PK parameter.
Measured: Evaluation was performed up to Day 36 or Day 72.
Apparent volume of distribution (Vd/F)
PK parameter.
Measured: Evaluation was performed up to Day 36 or Day 72.
Incidence and time of onset of Anti drug antibody (ADA) positivity in healthy participants receiving HRS-4139
Measured: Evaluation was performed up to Day 36 or Day 72.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2026
- Study start21 Sep 2026
- Primary completionMar 2027 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psoriasis VulgarisStudies of the same condition, open and under way.
- More trials run by Fujian Shengdi 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
- Parallel groups
- Model description
- Randomized, Double-blind, Placebo-controlled.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fujian Shengdi Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07802964
- Sponsor's protocol ID
- HRS-4139-101
- Status last verified
- Sep 2026
- First submitted
- 31 Aug 2026
- Last updated
- 25 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Dose-escalation Phase I Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Pharmacodynamics of a Single Oral Dose of HRS-4139 in Healthy Participants
- ClinicalTrials.gov ID
- NCT07802964
- Acronym / sponsor ID
- HRS-4139-101
- Conditions
- Psoriasis Vulgaris
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Fujian Shengdi Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 21 Sep 2026 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 3 Sep 2026 (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 Phase I clinical study aims to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single oral dose of HRS-4139 in healthy participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, Double-blind, Placebo-controlled.
| Arm | Type | Receives |
|---|---|---|
| HRS-4139 tablet group | Experimental | Drug: HRS-4139 Tablet |
| HRS-4139 placebo group | Placebo comparator | Drug: HRS-4139 Placebo |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Participants who understand the specific procedures of the trial, voluntarily agree to participate in this trial, and provide written informed consent.
- Participants aged 18 to 55 years (inclusive) at screening.
- Male body weight ≥ 50 kg, female body weight ≥ 45 kg, and body mass index (BMI) between 18.0 and 26.0 kg/m² (inclusive).
- Participants who are able to communicate effectively with the investigator, fully understand and comply with all requirements of the trial protocol.
Key exclusion criteria (10 listed)
- Participants with any disease of the circulatory, endocrine, neurological, digestive, respiratory, hematologic, immunologic, psychiatric, or metabolic systems, or any other condition that may interfere with the trial results.
- Participants with a history of malignancy.
- Participants with a history of risk factors for Torsades de Pointes (e.g., heart failure, hypokalemia), or with short QT syndrome or long QT syndrome, or with a family history in first-degree relatives of unexplained sudden death, drowning, or sudden infant death syndrome (SIDS) occurring at ≤ 40 years of age.
- Participants who have had an opportunistic infection within 6 months prior to screening; or who have a known history of recurrent or chronic infections, or who have had chronic or recurrent sinusitis, tonsillitis, urinary tract infections, prostatitis, enteritis, etc.
- Participants who have had an acute infection with systemic symptoms requiring systemic anti-infective therapy (intravenous or oral) within 4 weeks prior to screening.
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 |
|---|---|---|
| HRS-4139 TabletHRS-4139 tablet. | Drug | HRS-4139 tablet group |
| HRS-4139 PlaceboHRS-4139 placebo. | Drug | HRS-4139 placebo group |
Primary outcome
Adverse events (AEs)
Time frame: Evaluation was performed up to Day 36 or Day 72.
Serious Adverse events (SAEs)
Time frame: Evaluation was performed up to Day 36 or Day 72.
9 secondary outcomes
Plasma concentration of HRS-4139 in healthy participants
Time frame: Evaluation was performed up to Day 36 or Day 72.
Peak concentration (Cmax)
Time frame: Evaluation was performed up to Day 36 or Day 72.
Time to peak concentration (Tmax)
Time frame: Evaluation was performed up to Day 36 or Day 72.
Area under the concentration-time curve from time 0 to the last quantifiable time point (AUC0-last)
Time frame: Evaluation was performed up to Day 36 or Day 72.
Area under the concentration-time curve from time 0 to infinity (AUC0-inf)
Time frame: Evaluation was performed up to Day 36 or Day 72.
Elimination half-life (t1/2)
Time frame: Evaluation was performed up to Day 36 or Day 72.
Apparent clearance (CL/F)
Time frame: Evaluation was performed up to Day 36 or Day 72.
Apparent volume of distribution (Vd/F)
Time frame: Evaluation was performed up to Day 36 or Day 72.
Incidence and time of onset of Anti drug antibody (ADA) positivity in healthy participants receiving HRS-4139
Time frame: Evaluation was performed up to Day 36 or Day 72.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
- Individual participant dataSharing planned: Undecided
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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.
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 HRS-4139 Tablet in people with Psoriasis Vulgaris, run by Fujian Shengdi 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 4 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 25 Sep 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Meng Fu (+86-0518-82342973, meng.fu@hengrui.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse events (AEs) (time frame: Evaluation was performed up to Day 36 or Day 72.). The study lists 2 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 25 Sep 2026.