PsoriasisPhase 1NCT07078695
A Trial of SHR-1139 in Healthy Volunteers
A Phase 1 study testing SHR-1139 Injection in people with Psoriasis, run by Atridia Pty Ltd. at 1 site in Australia.
Trial summary
The purpose of this study is to assess safety, PK and immunogenicity profile of a single dose of SHR-1139 in healthy volunteers Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Psoriasis
- What is being tested?
- SHR-1139 Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteAustralia
- Study dates
- 19 Aug 2025to 30 Sep 2026
- 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
- Healthy white participants.
- Ability to understand the trial procedures and possible adverse events, volunteer to participate in the trial, and provide written informed consent, be able to comply with all the requirements, and able to complete the study.
- Male aged between 18 to 55 years of age (inclusive)
- Women with body weight ≥ 45.0 kg, men with body weight ≥ 50.0 kg, body mass index (BMI) between 18.0 and 30.0 kg/m2 (inclusive) at screening.
- Men and WOCBP must agree to take highly effective contraceptive methods
Who cannot join
- History or evidence of clinically significant disorders.
- Individuals with a history of drug allergies, specific allergies, or known history or suspected of being allergic to the study drug or any component of it.
- Receipt of medical devices or another investigational drug (including placebo) within 3 months or 5 half-lives, or in the follow-up period of a clinical study, whichever is longer (according to the date of the signed consent form) prior to screening.
- Unwilling or unable to comply with the Lifestyle Guidelines detailed in this protocol.
- Positive pregnancy test at screening or D-1/check-in.
- Any other circumstances (e.g., not suitable for venous access) or laboratory abnormality that, in the investigator's judgment, may increase the risk to the participant, or be associated with the participant's participation in and completion of the study or could preclude the evaluation of the participant's response.
- NOTE: Other protocol defined Inclusion/Exclusion criteria may apply
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Randomized, Open-label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Single Subcutaneous/Intravenous Administered SHR-1139 in Healthy Participants
The purpose of this study is to assess safety, PK and immunogenicity profile of a single dose of SHR-1139 in healthy volunteers
- Conditions
- Psoriasis
- Being tested
- SHR-1139 Injection
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR-1139 InjectionDrug
Single dose of SHR-1139 given subcutaneously (dose level 1 )
SHR-1139 InjectionDrug
Single dose of SHR-1139 given subcutaneously (dose level 2 )
SHR-1139 InjectionDrug
Single dose of SHR-1139 given intravenously (dose level 3)
| Study group | Role | What they receive |
|---|---|---|
| SHR-1139 dose level 1 | Experimental | Single dose of SHR-1139 given subcutaneously (dose level 1) Receives: Drug: SHR-1139 Injection |
| SHR-1139 dose level 2 | Experimental | Single dose of SHR-1139 given subcutaneously (dose level 2) Receives: Drug: SHR-1139 Injection |
| SHR-1139 dose level 3 | Experimental | Single dose of SHR-1139 given intravenously (dose level 3) Receives: Drug: SHR-1139 Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
PK profile of SHR-1139 after a single administration
Pharmacokinetics- Area under the concentration-time curve from time 0 to last time point after SHR-1139 administration (AUC0-last)
Measured: Start of Treatment to end of study (Day 253)
PK profile of SHR-1139 after a single administration
Pharmacokinetics- Area under the concentration-time curve (AUC0-inf)
Measured: From time 0 to infinity after SHR-1139 administration (Day 253)
PK profile of SHR-1139 after a single administration:
Pharmacokinetics- Time to Cmax of SHR-1139 (Tmax )
Measured: Start of Treatment to end of study (Day 253)
PK profile of SHR-1139 after a single administration
Pharmacokinetics-Terminal elimination half-life of SHR-1139 (t1/2)
Measured: Start of Treatment to end of study (Day 253)
Immunogenicity profile of SHR-1139 after a single dose administration
The number of participants with anti-drug antibody (ADA)
Measured: Day 253
Secondary outcomes (1)
Safety and Tolerability Based on Incidence and Severity of Treatment Emergent Adverse Events
Number of participants with Adverse events and Serious adverse events
Measured: Day 295
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2025
- Study start19 Aug 2025
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
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.
- 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
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Atridia Pty Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07078695
- Sponsor's protocol ID
- SHR-1139-102
- Status last verified
- Mar 2026
- First submitted
- 13 Jul 2025
- Last updated
- 19 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Open-label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Single Subcutaneous/Intravenous Administered SHR-1139 in Healthy Participants
- ClinicalTrials.gov ID
- NCT07078695
- Acronym / sponsor ID
- SHR-1139-102
- Conditions
- Psoriasis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Atridia Pty Ltd.Industry (pharma, biotech, devices)
- Study start
- 19 Aug 2025 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 22 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.
The purpose of this study is to assess safety, PK and immunogenicity profile of a single dose of SHR-1139 in healthy volunteers
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| SHR-1139 dose level 1 | Experimental | Drug: SHR-1139 InjectionSingle dose of SHR-1139 given subcutaneously (dose level 1) |
| SHR-1139 dose level 2 | Experimental | Drug: SHR-1139 InjectionSingle dose of SHR-1139 given subcutaneously (dose level 2) |
| SHR-1139 dose level 3 | Experimental | Drug: SHR-1139 InjectionSingle dose of SHR-1139 given intravenously (dose level 3) |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy white participants.
- Ability to understand the trial procedures and possible adverse events, volunteer to participate in the trial, and provide written informed consent, be able to comply with all the requirements, and able to complete the study.
- Male aged between 18 to 55 years of age (inclusive)
- Women with body weight ≥ 45.0 kg, men with body weight ≥ 50.0 kg, body mass index (BMI) between 18.0 and 30.0 kg/m2 (inclusive) at screening.
- Men and WOCBP must agree to take highly effective contraceptive methods
Key exclusion criteria (7 listed)
- History or evidence of clinically significant disorders.
- Individuals with a history of drug allergies, specific allergies, or known history or suspected of being allergic to the study drug or any component of it.
- Receipt of medical devices or another investigational drug (including placebo) within 3 months or 5 half-lives, or in the follow-up period of a clinical study, whichever is longer (according to the date of the signed consent form) prior to screening.
- Unwilling or unable to comply with the Lifestyle Guidelines detailed in this protocol.
- Positive pregnancy test at screening or D-1/check-in.
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 InjectionSingle dose of SHR-1139 given subcutaneously (dose level 1 ) | Drug | SHR-1139 dose level 1 |
| SHR-1139 InjectionSingle dose of SHR-1139 given subcutaneously (dose level 2 ) | Drug | SHR-1139 dose level 2 |
| SHR-1139 InjectionSingle dose of SHR-1139 given intravenously (dose level 3) | Drug | SHR-1139 dose level 3 |
Primary outcome
PK profile of SHR-1139 after a single administration
Time frame: Start of Treatment to end of study (Day 253)
Pharmacokinetics- Area under the concentration-time curve from time 0 to last time point after SHR-1139 administration (AUC0-last)
PK profile of SHR-1139 after a single administration
Time frame: From time 0 to infinity after SHR-1139 administration (Day 253)
Pharmacokinetics- Area under the concentration-time curve (AUC0-inf)
PK profile of SHR-1139 after a single administration:
Time frame: Start of Treatment to end of study (Day 253)
Pharmacokinetics- Time to Cmax of SHR-1139 (Tmax )
PK profile of SHR-1139 after a single administration
Time frame: Start of Treatment to end of study (Day 253)
Pharmacokinetics-Terminal elimination half-life of SHR-1139 (t1/2)
Immunogenicity profile of SHR-1139 after a single dose administration
Time frame: Day 253
The number of participants with anti-drug antibody (ADA)
1 secondary outcome
Safety and Tolerability Based on Incidence and Severity of Treatment Emergent Adverse Events
Time frame: Day 295
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 19 Mar 2026.
- Individual participant dataSharing planned: No
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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.
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 Injection in people with Psoriasis, run by Atridia Pty Ltd. at 1 site in Australia.
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 5 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: under way, not looking for participants, as of the sponsor's last update on 19 Mar 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 Australia. 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. 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?
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?
PK profile of SHR-1139 after a single administration (time frame: Start of Treatment to end of study (Day 253)). 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 19 Mar 2026.