A Study to Compare Pharmacokinetic and Safety Profiles of Different Formulations of SHR-1314 After Subcutaneous Injection in Healthy Subjects
NCT04326881 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30
Last updated 2020-03-30
Summary
This study will be a single-center, randomized, parallel, open-label, single dosing bridging study in healthy subjects to evaluate the pharmacokinetics and safety of two formulations of SHR-1314.
Conditions
- Pharmacokinetic
Interventions
- DRUG
-
SHR-1314
single dosing
Sponsors & Collaborators
-
Jiangsu HengRui Medicine Co., Ltd.
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- OTHER
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 45 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2020-04-07
- Primary Completion
- 2020-07-07
- Completion
- 2020-11-30
- FDA Drug
- Yes
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