Moderate to Severe Plaque PsoriasisPhase 1NCT07051538
A Phase I Clinical Trial of Single Subcutaneous Injection or Intravenous Infusion of SHR-1139 Injection in Healthy Chinese Subjects and Multiple Subcutaneous Injections in Patients With Moderate-to-severe Plaque Psoriasis
A Phase 1 study testing SHR-1139 Injections in people with Moderate to Severe Plaque Psoriasis, run by Guangdong Hengrui Pharmaceutical Co., Ltd at 1 site in China.
Trial summary
This is a clinical study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamic and immunogenicity of SHR-1139 injection in healthy subjects who receive a single subcutaneous injection or intravenous infusion of SHR-1139 injection, and in patients with moderate - to - severe plaque psoriasis who… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Moderate to Severe Plaque Psoriasis
- What is being tested?
- SHR-1139 Injections
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteChina
- Study dates
- 26 Jun 2024to 28 Nov 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects who fully understand the trial procedures, voluntarily agree to participate, and sign a written informed consent form.
- Age between 18 and 55 years old (inclusive).
- Vital signs, physical examinations, laboratory tests, and other assessments are normal or show abnormalities without clinical significance.
Who cannot join
- Subjects with any clinical disease in the circulatory, endocrine, nervous, digestive, respiratory, hematological, immunological, psychiatric systems, or metabolic abnormalities; or any other disease that may interfere with trial results.
- History of malignant tumor.
- Opportunistic infection within 6 months prior to screening.
- Acute infection with systemic symptoms requiring systemic intravenous or oral anti-infective treatment within 4 weeks before baseline.
- Participation in any drug or medical device clinical trial within 3 months prior to screening.
Trial locations and contacts
1 site in 1 country.
China1 site
Huashan Hospital, Fudan University
Shanghai, Shanghai Municipality, 200031
About this study
Official title: A Randomized, Double-Blind, Dose-Escalating, Placebo-controlled Phase I Clinical Trial on the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Subcutaneous Injection or Intravenous Infusion of SHR-1139 Injection in Healthy Chinese Subjects and Multiple Subcutaneous Injections in Patients With Moderate-to-severe Plaque Psoriasis
This is a clinical study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamic and immunogenicity of SHR-1139 injection in healthy subjects who receive a single subcutaneous injection or intravenous infusion of SHR-1139 injection, and in patients with moderate - to - severe plaque psoriasis who receive multiple subcutaneous injections of SHR-1139 injection.
- Conditions
- Moderate to Severe Plaque Psoriasis
- Being tested
- SHR-1139 Injections, SHR-1139 Injections Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR-1139 InjectionsDrug
SHR-1139 injections.
SHR-1139 Injections PlaceboDrug
SHR-1139 injections placebo
| Study group | Role | What they receive |
|---|---|---|
| SHR-1139 Injections Group | Experimental | Not described Receives: Drug: SHR-1139 Injections |
| SHR-1139 Injections Placebo Group | Placebo comparator | Not described Receives: Drug: SHR-1139 Injections Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events (AEs)
Measured: About 365 days for moderate-to-severe plaque psoriasis subjects
Adverse events (AEs)
Measured: About 295 days for healthy subjects.
Serious adverse events (SAEs)
Measured: About 295 days for healthy subjects.
Serious adverse events (SAEs)
Measured: About 365 days for moderate-to-severe plaque psoriasis subjects.
Secondary outcomes (2)
Serum concentration of SHR-1139
Measured: About 253 days for healthy subjects.
Serum concentration of SHR-1139
Measured: About 365 days for moderate-to-severe plaque psoriasis subjects.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2025
- Study start26 Jun 2024
- Primary completion28 Nov 2025
- Study completion28 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Moderate to Severe Plaque PsoriasisStudies of the same condition, open and under way.
- More trials run by Guangdong Hengrui Pharmaceutical Co., LtdThe 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guangdong Hengrui Pharmaceutical Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07051538
- Sponsor's protocol ID
- SHR-1139-101
- Status last verified
- Jan 2026
- First submitted
- 26 Jun 2025
- Last updated
- 28 Jan 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 28 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Dose-Escalating, Placebo-controlled Phase I Clinical Trial on the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Subcutaneous Injection or Intravenous Infusion of SHR-1139 Injection in Healthy Chinese Subjects and Multiple Subcutaneous Injections in Patients With Moderate-to-severe Plaque Psoriasis
- ClinicalTrials.gov ID
- NCT07051538
- Acronym / sponsor ID
- SHR-1139-101
- Conditions
- Moderate to Severe Plaque Psoriasis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Guangdong Hengrui Pharmaceutical Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 26 Jun 2024 (actual)
- Primary completion
- 28 Nov 2025 (actual)
- Study completion
- 28 Nov 2025 (actual)
- First posted
- 4 Jul 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 is a clinical study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamic and immunogenicity of SHR-1139 injection in healthy subjects who receive a single subcutaneous injection or intravenous infusion of SHR-1139 injection, and in patients with moderate - to - severe plaque psoriasis who receive multiple subcutaneous injections of SHR-1139 injection.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SHR-1139 Injections Group | Experimental | Drug: SHR-1139 Injections |
| SHR-1139 Injections Placebo Group | Placebo comparator | Drug: SHR-1139 Injections Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subjects who fully understand the trial procedures, voluntarily agree to participate, and sign a written informed consent form.
- Age between 18 and 55 years old (inclusive).
- Vital signs, physical examinations, laboratory tests, and other assessments are normal or show abnormalities without clinical significance.
Key exclusion criteria (5 listed)
- Subjects with any clinical disease in the circulatory, endocrine, nervous, digestive, respiratory, hematological, immunological, psychiatric systems, or metabolic abnormalities; or any other disease that may interfere with trial results.
- History of malignant tumor.
- Opportunistic infection within 6 months prior to screening.
- Acute infection with systemic symptoms requiring systemic intravenous or oral anti-infective treatment within 4 weeks before baseline.
- Participation in any drug or medical device clinical trial within 3 months 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 |
|---|---|---|
| SHR-1139 InjectionsSHR-1139 injections. | Drug | SHR-1139 Injections Group |
| SHR-1139 Injections PlaceboSHR-1139 injections placebo | Drug | SHR-1139 Injections Placebo Group |
Primary outcome
Adverse events (AEs)
Time frame: About 365 days for moderate-to-severe plaque psoriasis subjects
Adverse events (AEs)
Time frame: About 295 days for healthy subjects.
Serious adverse events (SAEs)
Time frame: About 295 days for healthy subjects.
Serious adverse events (SAEs)
Time frame: About 365 days for moderate-to-severe plaque psoriasis subjects.
2 secondary outcomes
Serum concentration of SHR-1139
Time frame: About 253 days for healthy subjects.
Serum concentration of SHR-1139
Time frame: About 365 days for moderate-to-severe plaque psoriasis subjects.
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 28 Jan 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Moderate to Severe Plaque Psoriasis
Active, not recruitingPhase 2
Dose Ranging Study of ORKA-001 in Patients With Moderate-to-Severe Plaque Psoriasis
Plaque Psoriasis
RecruitingPhase 1/2
A Study to Evaluate the Efficacy and Safety of CS32582 in Participants With Moderate to Severe Plaque Psoriasis
Plaque Psoriasis
Not yet recruitingPhase 3
A Study of Zasocitinib in Adults With Non-pustular Palmoplantar Psoriasis
Palmoplantar Psoriasis
RecruitingPhase 4
A Study to Investigate the Effectiveness of Tirzepatide (LY3298176) Following Initiation of Ixekizumab (LY2439821) in Participants With Moderate-to-Severe Plaque PsO and Obesity or Overweight in Clinical Practice (TOGETHER AMPLIFY-PsO)
Psoriasis, Overweight or Obesity
Active, not recruitingPhase 3
A Study of JNJ-77242113 for the Treatment of Participants With Moderate to Severe Plaque Psoriasis
Plaque Psoriasis
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 SHR-1139 Injections in people with Moderate to Severe Plaque Psoriasis, run by Guangdong Hengrui 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 5 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 28 Jan 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?
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?
Adverse events (AEs) (time frame: About 365 days for moderate-to-severe plaque psoriasis subjects). 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 28 Jan 2026.