Moderate-to-Severe Plaque PsoriasisPhase 1NCT06182384
A Clinical Study to Compare the Safety and Pharmacokinetics of SHR-1314 Injection in Healthy Subjects at Different Specifications Devices
A Phase 1 study testing SHR-1314 in people with Moderate-to-Severe Plaque Psoriasis, run by Suzhou Suncadia Biopharmaceuticals Co., Ltd. at 1 site in China.
Trial summary
The purpose of this study is to evaluate the safety and pharmacokinetics of SHR-1314 injection in healthy subjects at different specifications devices. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Moderate-to-Severe Plaque Psoriasis
- What is being tested?
- SHR-1314
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteChina
- Study dates
- 24 Dec 2023to 13 May 2024
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Voluntary signing of informed consent form before related activities of the experiment and understanding of the procedures and methods of the experiment, willing to strictly follow the clinical trial protocol to complete the experiment.
- Both men and women are eligible, aged 18 to 45 years old (inclusive, as determined at the time of signing informed consent form).
- Body mass index (BMI) is between 18 and 25 kg/m2 (inclusive), with male weight ≥ 50 kg and female weight ≥ 45 kg.
- Subjects with normal physical examination results and with normal laboratory results (blood, chemistry, urine, drug screening, coagulation function test), ECG and X-ray chest test are normal or with certain abnormal without clinical significance.
Who cannot join
- Having a history of any clinically significant disease or condition that the investigator believes may affect the trial results, including but not limited to a history of cardiovascular, endocrine, neurological, digestive, urinary, hematological, immunological, metabolic diseases, or existing diseases in these systems.
- Have a history of drug or other allergies, or are likely to be allergic to the investigational drug or any component of the investigational drug as determined by the investigator.
- History or current infection with human immunodeficiency virus (HIV) or hepatitis C; or current hepatitis B infection or syphilis.
- History of lymphoproliferative disease or any known malignancy or history of malignancy of any organ system within the past 5 years.
- History of chronic or recurrent infectious disease, or evidence of active or latent tuberculosis infection.
- Clinical symptoms, signs, laboratory tests, or X-rays suggest active or latent tuberculosis Tuberculosis infected persons;
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- Those who have participated in any clinical study for any drug or medical device within 3 months before screening
- Those who have received live attenuated vaccine within 12 weeks prior to screening or plan to receive live attenuated vaccine during the trial.
- Blood donation or blood loss ≥ 400 mL within 8 weeks prior to screening, or receiving blood transfusion within 8 weeks;
- Venous blood collection difficulties or physical conditions can not withstand blood collection;
- Had used other drugs (including prescription drugs, over-the-counter drugs, Chinese herbal medicines and dietary supplements) in the 2 weeks before screening;
- Current or past alcoholics (drinking more than 14 standard units per week) 1 Standard unit containing 14g of alcohol, such as 360 mL beer or 45 mL spirits with 40% alcohol or 150 mL wine); Or who cannot abstain from alcohol during the trial;
- The average daily smoking amount in the 3 months before the test was ≥ 10 cigarettes; Or cannot stop using any tobacco products during the trial
- History or evidence of ongoing alcohol or drug abuse, within the last six months before Baseline.
- Female and male subjects who are fertile (defined as having the physical conditions necessary to become pregnant) who plan to become pregnant or donate sperm/egg within 20 weeks of using the study drug (greater than 5 half-lives) or who do not wish to use contraception; Female subjects who are fertile but have not used contraception in the 30 days prior to randomization;
- Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test.
- Subjects judged by the investigator as unsuitable for participating in this study.
Trial locations and contacts
1 site in 1 country.
China1 site
The Second Hospital of Anhui Medical University
Hefei, Anhui, 300041
About this study
Official title: A Single-center, Randomized, Open, Two-period, Two-sequence Crossover Clinical Study to Compare the Safety and Pharmacokinetics of SHR-1314 Injection in Healthy Subjects at Different Specifications Devices
The purpose of this study is to evaluate the safety and pharmacokinetics of SHR-1314 injection in healthy subjects at different specifications devices.
- Conditions
- Moderate-to-Severe Plaque Psoriasis
- Being tested
- SHR-1314
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR-1314Drug
Receive a single dose of 240mg SHR-1314 at every period (First period：1mL AI, injection two needles. Second period: 2mL AI, injection one needle).
SHR-1314Drug
Receive a single dose of 240mg SHR-1314 at every period (First period：2mL AI, injection one needle. Second period: 1mL AI, injection two needles).
| Study group | Role | What they receive |
|---|---|---|
| Sequence A | Experimental | Not described Receives: Drug: SHR-1314 |
| Sequence B | Experimental | Not described Receives: Drug: SHR-1314 |
What is being measured
The primary outcome is the main question the study is designed to answer.
After a single subcutaneous injection of SHR-1314, assess injection site pain by VISUAL ANALOG SCALE at immediately after administration, 1 h, 48 h, Day 5 and Day 8, the results ranger from 0 to 10 cm, with higher scores indicating greater pain
Measured: Day 1 to Day 8 after each administration
After a single subcutaneous injection of SHR-1314, the incidence rate of injection site reaction at 1 h, 48 h, Day 5 and Day 8
Measured: Day 1 to Day 8 after each administration
Secondary outcomes (5)
After a single subcutaneous injection of SHR-1314, the PK parameters of plasma SHR-1314: Time to maximum concentration (Tmax)
Measured: Day 1 to Day 28
After a single subcutaneous injection of SHR-1314, the PK parameters of plasma SHR-1314: Area Under the Concentration versus time curve (AUC0-t)
Measured: Day 1 to Day 28
After a single subcutaneous injection of SHR-1314, the PK parameters of plasma SHR-1314: Maximum Concentration (Cmax)
Measured: Day 1 to Day 28
Safety indicators: The rate of adverse events (AE, including Injection site reactions), serious adverse events (SAE)
Measured: Screening period up to Day 43
Immunogenicity indicators: The rate of anti-SHR-1314 antibodies
Measured: Start of treatment up to Day 43
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2023
- Study start24 Dec 2023
- Primary completion13 May 2024
- Study completion13 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Moderate-to-Severe Plaque PsoriasisStudies of the same condition, open and under way.
- More trials run by Suzhou Suncadia Biopharmaceuticals 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
- Crossover
- Model description
- This study is a single-center, randomized, open-label, two-period, and two-sequence crossover design trial, consisting of two sequences (sequence A and sequence B) and two periods (first period and second period). Each sequence receives a same dose of SHR-1314 at every period.
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Suzhou Suncadia Biopharmaceuticals Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06182384
- Sponsor's protocol ID
- SHR-1314-106
- Status last verified
- Jun 2024
- First submitted
- 4 Dec 2023
- Last updated
- 14 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Dong Y, Gao X, Feng S, Lin L, Shen K, Hu W. Safety, pharmacokinetics, and bioequivalence of vunakizumab injection, a specific dermatitis drug, in healthy Chinese volunteers: an open-label, randomized, two-stage, two-sequence cross-over study. Expert Opin Drug Metab Toxicol. 2025 Sep;21(9):1117-1123. doi: 10.1080/17425255.2025.2558829. Epub 2025 Sep 15.
PubMed 40947125
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center, Randomized, Open, Two-period, Two-sequence Crossover Clinical Study to Compare the Safety and Pharmacokinetics of SHR-1314 Injection in Healthy Subjects at Different Specifications Devices
- ClinicalTrials.gov ID
- NCT06182384
- Acronym / sponsor ID
- SHR-1314-106
- Conditions
- Moderate-to-Severe Plaque Psoriasis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Suzhou Suncadia Biopharmaceuticals Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 24 Dec 2023 (actual)
- Primary completion
- 13 May 2024 (actual)
- Study completion
- 13 May 2024 (actual)
- First posted
- 26 Dec 2023 (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 evaluate the safety and pharmacokinetics of SHR-1314 injection in healthy subjects at different specifications devices.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study is a single-center, randomized, open-label, two-period, and two-sequence crossover design trial, consisting of two sequences (sequence A and sequence B) and two periods (first period and second period). Each sequence receives a same dose of SHR-1314 at every period.
| Arm | Type | Receives |
|---|---|---|
| Sequence A | Experimental | Drug: SHR-1314 |
| Sequence B | Experimental | Drug: SHR-1314 |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Voluntary signing of informed consent form before related activities of the experiment and understanding of the procedures and methods of the experiment, willing to strictly follow the clinical trial protocol to complete the experiment.
- Both men and women are eligible, aged 18 to 45 years old (inclusive, as determined at the time of signing informed consent form).
- Body mass index (BMI) is between 18 and 25 kg/m2 (inclusive), with male weight ≥ 50 kg and female weight ≥ 45 kg.
- Subjects with normal physical examination results and with normal laboratory results (blood, chemistry, urine, drug screening, coagulation function test), ECG and X-ray chest test are normal or with certain abnormal without clinical significance.
Key exclusion criteria (17 listed)
- Having a history of any clinically significant disease or condition that the investigator believes may affect the trial results, including but not limited to a history of cardiovascular, endocrine, neurological, digestive, urinary, hematological, immunological, metabolic diseases, or existing diseases in these systems.
- Have a history of drug or other allergies, or are likely to be allergic to the investigational drug or any component of the investigational drug as determined by the investigator.
- History or current infection with human immunodeficiency virus (HIV) or hepatitis C; or current hepatitis B infection or syphilis.
- History of lymphoproliferative disease or any known malignancy or history of malignancy of any organ system within the past 5 years.
- History of chronic or recurrent infectious disease, or evidence of active or latent tuberculosis infection.
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-1314Receive a single dose of 240mg SHR-1314 at every period (First period：1mL AI, injection two needles. Second period: 2mL AI, injection one needle). | Drug | Sequence A |
| SHR-1314Receive a single dose of 240mg SHR-1314 at every period (First period：2mL AI, injection one needle. Second period: 1mL AI, injection two needles). | Drug | Sequence B |
Primary outcome
After a single subcutaneous injection of SHR-1314, assess injection site pain by VISUAL ANALOG SCALE at immediately after administration, 1 h, 48 h, Day 5 and Day 8, the results ranger from 0 to 10 cm, with higher scores indicating greater pain
Time frame: Day 1 to Day 8 after each administration
After a single subcutaneous injection of SHR-1314, the incidence rate of injection site reaction at 1 h, 48 h, Day 5 and Day 8
Time frame: Day 1 to Day 8 after each administration
5 secondary outcomes
After a single subcutaneous injection of SHR-1314, the PK parameters of plasma SHR-1314: Time to maximum concentration (Tmax)
Time frame: Day 1 to Day 28
After a single subcutaneous injection of SHR-1314, the PK parameters of plasma SHR-1314: Area Under the Concentration versus time curve (AUC0-t)
Time frame: Day 1 to Day 28
After a single subcutaneous injection of SHR-1314, the PK parameters of plasma SHR-1314: Maximum Concentration (Cmax)
Time frame: Day 1 to Day 28
Safety indicators: The rate of adverse events (AE, including Injection site reactions), serious adverse events (SAE)
Time frame: Screening period up to Day 43
Immunogenicity indicators: The rate of anti-SHR-1314 antibodies
Time frame: Start of treatment up to Day 43
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 14 Jun 2024.
- Derived from this study: PubMed 40947125Dong Y, Gao X, Feng S, Lin L, Shen K, Hu W. Safety, pharmacokinetics, and bioequivalence of vunakizumab injection, a specific dermatitis drug, in healthy Chinese volunteers: an open-label, randomized, two-stage, two-sequence cross-over study. Expert Opin Drug Metab Toxicol. 2025 Sep;21(9):1117-1123. doi: 10.1080/17425255.2025.2558829. Epub 2025 Sep 15.
- 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. 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-1314 in people with Moderate-to-Severe Plaque Psoriasis, run by Suzhou Suncadia Biopharmaceuticals 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 17 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 14 Jun 2024. 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. 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?
After a single subcutaneous injection of SHR-1314, assess injection site pain by VISUAL ANALOG SCALE at immediately after administration, 1 h, 48 h, Day 5 and Day 8, the results ranger from 0 to 10 cm, with higher scores indicating greater pain (time frame: Day 1 to Day 8 after each administration). 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?
On the ClinicalTrials.gov record for NCT06182384, which also lists 1 linked publication.
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 14 Jun 2024.