A Clinical Study to Compare the Safety and Pharmacokinetics of SHR-1314 Injection in Healthy Subjects at Different Specifications Devices

Study Purpose

The purpose of this study is to evaluate the safety and pharmacokinetics of SHR-1314 injection in healthy subjects at different specifications devices.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.

An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.

Searching Both is inclusive of interventional and observational studies.

Eligible Ages 18 Years - 45 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. 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. 2. Both men and women are eligible, aged 18 to 45 years old (inclusive, as determined at the time of signing informed consent form). 3. Body mass index (BMI) is between 18 and 25 kg/m2 (inclusive), with male weight ≥ 50 kg and female weight ≥ 45 kg. 4. 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.

Exclusion Criteria:

1. 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. 2. 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. 3. History or current infection with human immunodeficiency virus (HIV) or hepatitis C; or current hepatitis B infection or syphilis. 4. History of lymphoproliferative disease or any known malignancy or history of malignancy of any organ system within the past 5 years. 5. History of chronic or recurrent infectious disease, or evidence of active or latent tuberculosis infection. 6. Clinical symptoms, signs, laboratory tests, or X-rays suggest active or latent tuberculosis Tuberculosis infected persons; 7. Those who have participated in any clinical study for any drug or medical device within 3 months before screening. 8. Those who have received live attenuated vaccine within 12 weeks prior to screening or plan to receive live attenuated vaccine during the trial. 9. Blood donation or blood loss ≥ 400 mL within 8 weeks prior to screening, or receiving blood transfusion within 8 weeks; 10. Venous blood collection difficulties or physical conditions can not withstand blood collection; 11. Had used other drugs (including prescription drugs, over-the-counter drugs, Chinese herbal medicines and dietary supplements) in the 2 weeks before screening; 12. 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; 13. 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. 14. History or evidence of ongoing alcohol or drug abuse, within the last six months before Baseline. 15. 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; 16. 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. 17. Subjects judged by the investigator as unsuitable for participating in this study.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.


Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 1
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Suzhou Suncadia Biopharmaceuticals Co., Ltd.
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Overall Status Recruiting
Countries China

The disease, disorder, syndrome, illness, or injury that is being studied.

Moderate-to-Severe Plaque Psoriasis
Arms & Interventions


Experimental: Sequence A

Experimental: Sequence B


Drug: - SHR-1314

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).

Drug: - SHR-1314

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).

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Hefei, Anhui, China




The Second Hospital of Anhui Medical University

Hefei, Anhui, 300041

Site Contact

Wei Hu, Doctor



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