A Study Comparing a Pre-filled Safety Syringe and an Autoinjector for SHR-1703 Injection in Healthy Participants
NCT07701239 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 84
Last updated 2026-07-14
Summary
This is a single-center, randomized, parallel-group, open-label clinical study designed to compare the bioavailability and safety of SHR-1703 Injection administered subcutaneously using a pre-filled safety syringe (PFS) or a pre-filled autoinjector (AI) in healthy participants.
A total of 84 healthy participants are planned to be enrolled and randomized in a 1:1 ratio to either the PFS group or the AI group. Participants in the PFS group will receive a single subcutaneous injection of SHR-1703 Injection using a pre-filled safety syringe, while participants in the AI group will receive a single subcutaneous injection of SHR-1703 Injection using a pre-filled autoinjector.
Conditions
- Asthma With Eosinophilic Phenotype
Interventions
- DRUG
-
SHR-1703 Injection
A single subcutaneous dose of SHR-1703 Injection administered via pre-filled safety syringe.
- DRUG
-
SHR-1703 Injection
A single subcutaneous dose of SHR-1703 Injection administered via autoinjector.
Sponsors & Collaborators
-
Guangdong Hengrui Pharmaceutical Co., Ltd
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 55 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2026-07-31
- Primary Completion
- 2027-04-30
- Completion
- 2027-04-30
Countries
- China
Study Locations
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