Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
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 and Over|
Inclusion Criteria:- Provide written informed consent before any study assessment is performed.
- - Male or female at least 18 years of age at screening.
- - Chronic plaque psoriasis history ≥ 6 months;At the time of randomization, moderate to severe plaque psoriasis.
- - Subject is a candidate for systemic psoriasis therapy and/or phototherapy and/or chemo phototherapy.
- - The body mass index (BMI) was ≥18 kg/m2 and ≤35 kg/m2 at screening.
Exclusion Criteria:- Diagnosis of psoriasis at screening is not chronic plaque psoriasis - Severe infection or systemic infection before baseline - There are other skin problems that researchers believe will hinder the evaluation of psoriasis.
- - Subject has a history or symptom of malignancy within 5 years prior to screening, regardless of whether or not treatment has been received, with or without signs of recurrence or metastasis.
- - The investigators believe that the subject is not suitable for any clinical condition involved in the clinical study.
- - Those who are allergic to the study ingredients or excipients, or who are allergic to other biological agents.
- - There is evidence that hepatitis B, hepatitis C, or human immunodeficiency virus (HIV) confirmation test is positive.
- - Subject's medical history, symptoms and examination results suggest active tuberculosis or latent tuberculosis.
- - Laboratory tests have clinical implications at screening, and the investigators believe that participation in the study may pose unacceptable risks to the subject or impede data analysis.
- - Women who are pregnant or breastfeeding at screening or at baseline - The investigator believes that it will prevent the subject from following and completing any other circumstances of the study protocol.
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.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
|Jiangsu HengRui Medicine Co., Ltd.|
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Principal Investigator Affiliation||N/A|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
|Overall Status||Not yet recruiting|
The disease, disorder, syndrome, illness, or injury that is being studied.
This study was a multicenter, parallel, randomized, double-blind, placebo-controlled clinical trial designed to evaluate the efficacy ,safety, tolerance, and pharmacokinetics (PK) of different SHR-1314 dosing regimens in moderate to severe chronic plaque psoriasis in adults.
Active Comparator: Treatment group A
SHR-1314 low dose short intervals of subcutaneous injection
Active Comparator: Treatment group B
SHR-1314 high dose long intervals of subcutaneous injection
Active Comparator: Treatment group C
SHR-1314 high dose short intervals of subcutaneous injection
Placebo Comparator: Placebo group
Placebo was subcutaneously injected into the 16 weeks turnover SHR-1314 subcutaneous injection
Biological: - IL-17A Antagonist
SHR-1314 subcutaneous injection
Biological: - Placebos
placebo subcutaneous injection to maintain consistency and to prevent blindness