Study of Bioavailability, Pharmacodynamics and Safety of SHR-1209 Administered by Single Subcutaneous Injection at Different Sites in Healthy Volunteers
Study Details
Study Description
Brief Summary
In order to meet the preferences and needs of different patients for injection sites and improve the medication compliance of patients, it is planned to compare the bioavailability, pharmacokinetics, pharmacodynamic and safety data to assess feasibility of multiple injection sites for administration.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Treatment group A
|
Drug: SHR-1209
SHR-1209，single subcutaneous injection of 450mg
|
| Experimental: Treatment group B
|
Drug: SHR-1209
SHR-1209，single subcutaneous injection of 450mg
|
| Experimental: Treatment group C
|
Drug: SHR-1209
SHR-1209，single subcutaneous injection of 450mg
|
Outcome Measures
Primary Outcome Measures
- Pharmacokinetic parameters of single subcutaneous injection of SHR-1209: area under the curve (AUC0-t) [Days 1-113]
- Pharmacokinetic parameters of single subcutaneous injection of SHR-1209: area under the curve (AUC0-∞) [Days 1-113]
- Pharmacokinetic parameters of single subcutaneous injection of SHR-1209: peak concentration (Coax) [Days 1-113]
Secondary Outcome Measures
- Pharmacokinetic parameters of single subcutaneous injection of SHR-1209: time to peak (Tmax) [Days 1-113]
- Pharmacokinetic parameters of single subcutaneous injection of SHR-1209: terminal elimination half-life (t1/2) [Days 1-113]
- Pharmacokinetic parameters of single subcutaneous injection of SHR-1209: apparent volume of distribution (Vz/F) [Days 1-113]
- Pharmacokinetic parameters of single subcutaneous injection of SHR-1209: apparent clearance (CL/F) [Days 1-113]
- Incidence and severity of adverse events (AE), serious adverse events (SAE), etc. [Days 1-113]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Understanding the research procedures and methods, being able to complete the research in accordance with the procedure requirements, and sign the informed consent;
-
The age on the date of signing the informed consent must be ≥18 years old and ≤55 years old;
-
Body mass index (BMI) at screening period must be ≥18.5 kg/m2 and <30.0 kg/m2, weight of male must≥ 50.0 kg and <90.0 kg, and female≥ 45.0 kg and <90.0 kg;
-
The subjects and their female partners are willing to have no reproductive plan from 2 weeks before screening to 6 months after the administration of the study drug, and voluntarily take effective contraceptive measures and do not plan to donate sperm or ovum.
Exclusion Criteria:
- History of the following diseases or treatments:
Diseases that affect drug absorption, distribution, metabolism, and excretion determined by the investigator; Serious infection within 3 months before screening; History of drug allergy or atopic allergic disease (asthma, urticaria).
- Any one of the following tests at Screening period or Baseline period:
Human immunodeficiency virus antibody (HIV-Ab), syphilis serological examination, hepatitis B virus surface antigen (HBsAg), hepatitis C virus antibody (HCV-Ab) positive; Positive blood pregnancy test.
- General situation:
Have a history of drug use or drug abuse; Women who are pregnant or breastfeeding.
- Subjects who are considered by the investigator to have any other factors which are not suitable for participating in this study.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Jiangsu HengRui Medicine Co., Ltd.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- SHR-1209-104