Atopic Dermatitis
Conditions
Brief summary
This study is a randomized, parallel-group, open-label Phase I clinical trial designed to compare the bioavailability and safety of subcutaneous SHR-1819 injection administered via different injection devices in healthy subjects.
Interventions
SHR-1819 injection.
Sponsors
Guangdong Hengrui Pharmaceutical Co., Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
1. Understanding the research procedures and methods, being able to complete the research in accordance with the procedure requirements, and sign the informed consent; 2. The age on the date of signing the informed consent must be ≥18 years old and ≤55 years old; 3. Body mass index (BMI) at screening period must be ≥19.0 kg/m2 and \<26.0 kg/m2, weight of male must≥ 50.0 kg and \<80.0 kg; 4. The subjects and their female partners are willing to have no reproductive plan from signing the informed consent to 3 months after the last administration of the study drug, and voluntarily take effective contraceptive measures and do not plan to donate sperm or ovum.
Exclusion criteria
1. History of the following diseases or treatments: (1) Receipt of a live-attenuated vaccine within 1 month prior to screening or planned receipt during the study; (2) Previous participation in a clinical trial involving any investigational product (drug or device) within 3 months before screening; (3) History of food or drug allergy or atopic allergic disease (asthma, urticaria); 2. Any one of the following tests at Screening period or Baseline period: (1) Human immunodeficiency virus antibody (HIV-Ab), syphilis serological examination, hepatitis B virus surface antigen (HBsAg), hepatitis C virus antibody (HCV-Ab) positive; (2) Exclude individuals who have experienced severe trauma or undergone major surgery within the past 6 months, or who plan to undergo surgery during the trial period; 3. General situation: (1) Have a history of drug use or drug abuse; (2) Investigators, site staff, or any other individuals directly involved in the conduct of the protocol; 4. Subjects who are considered by the investigator to have any other factors which are not suitable for participating in this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Area under the serum concentration versus time curve from time zero to the real time of last measurable concentration (AUClast). | Day 1 - Day 71. | — |
| Peak concentration (Cmax) | Day 1 - Day 71. | Pharmacokinetic parameters of multiple-site subcutaneous injection of SHR-1819. |
Secondary
| Measure | Time frame |
|---|---|
| SHR-1819 Anti-Drug Antibodies (ADA) | Day1; Day22 ; Day43; Day71. |
| Incidence and severity of adverse events (AEs) | Day 1 - Day 71. |
Countries
China
Outcome results
None listed