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
This Phase I clinical study aims to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single oral dose of HRS-4139 in healthy participants.
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 →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.
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.
Exclusion Criteria:
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.
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.
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.
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.
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.
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.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: HRS-4139 Tablet
Drug: HRS-4139 Placebo
HRS-4139 tablet.
HRS-4139 placebo.
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.
Plasma concentration of HRS-4139 in healthy participants
Time frame: Evaluation was performed up to Day 36 or Day 72.
Peak concentration (Cmax)
PK parameter.
Time frame: Evaluation was performed up to Day 36 or Day 72.
Time to peak concentration (Tmax)
PK parameter.
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)
PK parameter.
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)
PK parameter.
Time frame: Evaluation was performed up to Day 36 or Day 72.
Elimination half-life (t1/2)
PK parameter.
Time frame: Evaluation was performed up to Day 36 or Day 72.
Apparent clearance (CL/F)
PK parameter.
Time frame: Evaluation was performed up to Day 36 or Day 72.
Apparent volume of distribution (Vd/F)
PK parameter.
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.
Plan to share: Undecided
No publications or documents are linked to this record.
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.
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 ↗
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