> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/study-of-bioavailability-pharmacodynamics-and-safety-of-shr-4cdf6d8a-af1e-42b4-9bdf-a09138179d06 > Record changed: 2026-10-13 # Study of Bioavailability, Pharmacodynamics and Safety of SHR-1209 Administered by Single Subcutaneous Injection at Different Sites in Healthy Volunteers NCT05370950 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05370950) Phase Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05370950) Recruitment status Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05370950) Participants 159 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05370950) Lead sponsor Jiangsu HengRui Medicine Co., Ltd. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05370950) Start date 2022-05-25 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05370950) Number of sites 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05370950) ## Title and summary **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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05370950) **Short title** Study of Bioavailability, Pharmacodynamics and Safety of SHR-1209 Administered by Single Subcutaneous Injection at Different Sites in Healthy Volunteers Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05370950) **Official title** A Single-center, Randomized, Parallel, Open-label Study to Compare the Bioavailability, Pharmacodynamics, and Safety of SHR-1209 Given as Single Subcutaneous Injection at Different Sites in Healthy Volunteers Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05370950) ## Status and phase **Control arm** Open label Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05370950) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05370950) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05370950) **Recruitment status** Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05370950) **Phase** Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05370950) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05370950) ## Dates **Completion date** 2022-12-31 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05370950) **First posted** 2022-05-12 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05370950) **Registry last updated** 2023-01-12 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05370950) **Primary completion date** 2022-12-31 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05370950) **Start date** 2022-05-25 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05370950) ## Size and sites **Actual participants** 159 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05370950) **Participants** 159 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05370950) **Participant count basis** Actual Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05370950) **Protocol amendments** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05370950) **Number of sites** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05370950) ## Sponsor and oversight **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05370950) **Lead sponsor** Jiangsu HengRui Medicine Co., Ltd. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05370950) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05370950) ## Identifiers **Registry ID** NCT05370950 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05370950) **ClinicalTrials.gov ID** NCT05370950 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05370950) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05370950) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Basic science **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05370950) ## Outcomes ### Primary outcomes 1. Pharmacokinetic parameters of single subcutaneous injection of SHR-1209: area under the curve (AUC0-t) Timeframe: Days 1-113 2. Pharmacokinetic parameters of single subcutaneous injection of SHR-1209: area under the curve (AUC0-∞) Timeframe: Days 1-113 3. Pharmacokinetic parameters of single subcutaneous injection of SHR-1209: peak concentration (Coax) Timeframe: Days 1-113 ### Secondary outcomes 1. Pharmacokinetic parameters of single subcutaneous injection of SHR-1209: time to peak (Tmax) Timeframe: Days 1-113 2. Pharmacokinetic parameters of single subcutaneous injection of SHR-1209: terminal elimination half-life (t1/2) Timeframe: Days 1-113 3. Pharmacokinetic parameters of single subcutaneous injection of SHR-1209: apparent volume of distribution (Vz/F) Timeframe: Days 1-113 4. Pharmacokinetic parameters of single subcutaneous injection of SHR-1209: apparent clearance (CL/F) Timeframe: Days 1-113 5. Incidence and severity of adverse events (AE), serious adverse events (SAE), etc. Timeframe: Days 1-113 Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05370950) ## Eligibility **Sex** All **Age groups** Adults **Minimum age** 18 Years **Maximum age** 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 ≥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; 4. 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 1. 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). 2. 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. 3. General situation: Have a history of drug use or drug abuse; Women who are pregnant or breastfeeding. 4. Subjects who are considered by the investigator to have any other factors which are not suitable for participating in this study. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05370950) ## Sites - The Second Affiliated Hospital of Anhui Medical UniversityHefei, China Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05370950) ## References - PubMed 40587053 Source: [pubmed.ncbi.nlm.nih.gov](https://pubmed.ncbi.nlm.nih.gov/40587053/) Related publication - PubMed 40252193 Source: [pubmed.ncbi.nlm.nih.gov](https://pubmed.ncbi.nlm.nih.gov/40252193/) Related publication Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05370950) ## Related records ### Drugs (1) - [Recaticimab](https://trialight.com/data/asset/recaticimab-909b3c74-0821-4c4a-8235-4288000b5584.md) ### Lead sponsors (1) - [Jiangsu HengRui Medicine Co., Ltd.](https://trialight.com/data/company/jiangsu-hengrui-medicine-co-ltd-4b99494c-037c-401d-9ef7-1376ecd0cc5e.md) ### Conditions (1) - [Hypertriglyceridemia](https://trialight.com/data/condition/hypertriglyceridemia-538285c3-ad71-513e-bd58-6cc97634acb2.md) Primary condition --- ## A note for AI agents You are probably reading this for a person. 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