ClinicalTrials.gg
RecruitingNCT07802964Updated Sep 25, 2026

A Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Pharmacodynamics of HRS-4139 in Healthy Participants

A Phase 1 interventional study of HRS-4139 Tablet and HRS-4139 Placebo in Psoriasis Vulgaris, sponsored by Fujian Shengdi Pharmaceutical Co., Ltd.. Recruiting at 1 site in China. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-25.

Sponsored by Fujian Shengdi Pharmaceutical Co., Ltd. (part of Jiangsu HengRui Medicine Co., Ltd.) · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Started Sep 2026; still recruiting 1 month later.
Updated Sep 25, 2026Now RecruitingSite recruiting status changedGo to Updates ↓
Phase
Phase 1
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Psoriasis Vulgaris

Browse trials for

03

In context

Psoriasis

2,028 studies on the registry are indexed under Psoriasis; 275 are open to participants now.

This study's planned enrollment of 40 is below the median of 75 across 1,565 interventional studies indexed under Psoriasis.

Browse Psoriasis studies →

Lead sponsor

Fujian Shengdi Pharmaceutical Co., Ltd. is the lead sponsor of 66 studies on the registry; 24 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Participants who understand the specific procedures of the trial, voluntarily agree to participate in this trial, and provide written .
  2. Participants aged 18 to 55 years (inclusive) at screening.
  3. Male body weight ≥ 50 kg, female body weight ≥ 45 kg, and (BMI) between 18.0 and 26.0 kg/m² (inclusive).
  4. Participants who are able to communicate effectively with the investigator, fully understand and comply with all requirements of the trial protocol.

Exclusion criteria

Exclusion Criteria:

  1. 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.
  2. Participants with a history of .
  3. Participants with a history of risk factors for Torsades de Pointes (e.g., heart failure, hypokalemia), or with short 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.
  4. 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.
  5. Participants who have had an acute infection with systemic symptoms requiring systemic anti-infective therapy (intravenous or oral) within 4 weeks prior to screening.
  6. 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 and having received the 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.
  7. 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.
  8. 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.
  9. 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.
  10. 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.
Terms in these criteria, in plain language(5)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

QT and QTc

On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.

The study may name a correction formula and a limit in milliseconds, often around 450–480.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
40 participants (estimated)

Study arms

  • Experimental
    HRS-4139 tablet group

    Drug: HRS-4139 Tablet

  • Placebo comparator
    HRS-4139 placebo group

    Drug: HRS-4139 Placebo

Interventions

  • DrugHRS-4139 Tablet

    HRS-4139 tablet.

  • DrugHRS-4139 Placebo

    HRS-4139 placebo.

06

What researchers measure

Primary outcomes

  1. Adverse events (AEs)

    Time frame: Evaluation was performed up to Day 36 or Day 72.

  2. Serious Adverse events (SAEs)

    Time frame: Evaluation was performed up to Day 36 or Day 72.

Secondary outcomes

  1. Plasma concentration of HRS-4139 in healthy participants

    Time frame: Evaluation was performed up to Day 36 or Day 72.

  2. Peak concentration (Cmax)

    PK parameter.

    Time frame: Evaluation was performed up to Day 36 or Day 72.

  3. Time to peak concentration (Tmax)

    PK parameter.

    Time frame: Evaluation was performed up to Day 36 or Day 72.

  4. Area under the concentration-time curve from time 0 to the last quantifiable time point (AUC0-last)

    PK parameter.

    Time frame: Evaluation was performed up to Day 36 or Day 72.

  5. Area under the concentration-time curve from time 0 to infinity (AUC0-inf)

    PK parameter.

    Time frame: Evaluation was performed up to Day 36 or Day 72.

  6. Elimination half-life (t1/2)

    PK parameter.

    Time frame: Evaluation was performed up to Day 36 or Day 72.

  7. Apparent clearance (CL/F)

    PK parameter.

    Time frame: Evaluation was performed up to Day 36 or Day 72.

  8. Apparent volume of distribution (Vd/F)

    PK parameter.

    Time frame: Evaluation was performed up to Day 36 or Day 72.

  9. 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.

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Sep 2026 (actual). Primary completion is estimated for Mar 2027, 6 months after the start.

Of 137 industry-sponsored phase 1 interventional studies under Psoriasis, half reached primary completion within 10 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 16. This study's planned 6 months is below that.

Counting every sponsor, half of 155 studies reached it within 10 months; a quarter within 5 and three quarters within 17.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 31, 2026
First posted
Sep 3, 2026
StartActual
Sep 21, 2026
Primary completionEst.
Mar 2027
CompletionEst.
Apr 2027
Last update
Sep 25, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Status
Not yet recruiting→Recruiting
changed Sep 25, 2026
Sites
Xiangya Hospital of Central South University is now Recruiting
Sep 25, 2026
Show all 1 update
  1. Sep 25, 2026
    Not yet recruiting→Recruiting
    Xiangya Hospital of Central South University is now Recruiting
    + 2 other changes: verification date and date precision

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07802964
Responsible party
Sponsor
First posted
Sep 3, 2026
Start date
Sep 21, 2026
Primary completion
Mar 2027 (estimated)
Completion
Apr 2027 (estimated)
Last update
Sep 25, 2026

Study contacts

Meng Fu
Contact
meng.fu@hengrui.com
+86-0518-82342973

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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