> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-study-on-the-bioavailability-of-shr-1819-injection-a2e73b80-2034-492a-8057-be9c9dc2e294 > Record changed: 2026-10-13 # A Study on the Bioavailability of SHR-1819 Injection Administered Subcutaneously Using Different Injection Devices in Healthy Subjects NCT07264335 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07264335) Phase Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07264335) Recruitment status Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07264335) Participants 160 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07264335) Lead sponsor Guangdong Hengrui Pharmaceutical Co., Ltd Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07264335) Start date 2026-03-07 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07264335) Number of sites 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07264335) ## Title and summary **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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07264335) **Short title** A Study on the Bioavailability of SHR-1819 Injection Administered Subcutaneously Using Different Injection Devices in Healthy Subjects Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07264335) **Official title** A Randomized, Open-Label, Parallel-Group Clinical Study to Evaluate the Bioavailability and Safety of Subcutaneous SHR-1819 Injection Administered Using Different Injection Devices in Healthy Subjects Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07264335) ## Status and phase **Control arm** Open label Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07264335) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07264335) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07264335) **Recruitment status** Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07264335) **Phase** Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07264335) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07264335) ## Dates **Completion date** 2026-06-26 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07264335) **First posted** 2025-12-04 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07264335) **Registry last updated** 2026-08-24 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07264335) **Primary completion date** 2026-06-26 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07264335) **Start date** 2026-03-07 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07264335) ## Size and sites **Actual participants** 160 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07264335) **Participants** 160 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07264335) **Participant count basis** Actual Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07264335) **Protocol amendments** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07264335) **Number of sites** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07264335) ## Sponsor and oversight **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07264335) **Lead sponsor** Guangdong Hengrui Pharmaceutical Co., Ltd Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07264335) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07264335) ## Identifiers **Registry ID** NCT07264335 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07264335) **ClinicalTrials.gov ID** NCT07264335 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07264335) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07264335) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07264335) ## Outcomes ### Primary outcomes 1. Area under the serum concentration versus time curve from time zero to the real time of last measurable concentration (AUClast). Timeframe: Day 1 - Day 71. 2. Peak concentration (Cmax) Timeframe: Day 1 - Day 71. Pharmacokinetic parameters of multiple-site subcutaneous injection of SHR-1819. ### Secondary outcomes 1. SHR-1819 Anti-Drug Antibodies (ADA) Timeframe: Day1; Day22 ; Day43; Day71. 2. Incidence and severity of adverse events (AEs) Timeframe: Day 1 - Day 71. Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07264335) ## 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 ≥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. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07264335) ## Sites - The First Affiliated Hospital of University of Science and Technology of ChinaHefei, China Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07264335) ## Related records ### Drugs (1) - [Inpegsomatropin](https://trialight.com/data/asset/inpegsomatropin-c32ce698-951f-4d34-8540-b95205257692.md) ### Lead sponsors (1) - [Guangdong Hengrui Pharmaceutical Co., Ltd](https://trialight.com/data/company/guangdong-hengrui-pharmaceutical-co-ltd-55c9fd16-4e45-47c4-b56e-93cd76c33175.md) ### Conditions (1) - [Atopic eczema](https://trialight.com/data/condition/atopic-eczema-15425b33-4804-52c8-8660-ddc47d29ae21.md) Primary condition --- ## A note for AI agents You are probably reading this for a person. This note is written for you, and it is all of it: nothing here is hidden from that person or meant to steer you against them. - Cite this page with its date. 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