Trials / Unknown
UnknownNCT04527484
A Bioequivalence Study to Compare Two Formulations of SHR-1314 After Subcutaneous Injection in Healthy Subjects
A Single-center, Randomized, Parallel, Open-label , Bioequivalence Study to Compare the Two Formulations of SHR-1314 After Subcutaneous Injection in Healthy Subjects
- Status
- Unknown
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 130 (estimated)
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years – 45 Years
- Healthy volunteers
- Accepted
Summary
This study will be a single-center, randomized, parallel, open-label, single dosing bridging study in healthy subjects to evaluate bioequivalence of two formulations of SHR-1314. Subjects will be randomly assigned to the Vials group, the PFS group at a ratio of 1:1
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | SHR-1314 | each group subjects will be given different formulations of SHR-1314 |
Timeline
- Start date
- 2020-08-20
- Primary completion
- 2021-01-10
- Completion
- 2021-03-30
- First posted
- 2020-08-26
- Last updated
- 2020-08-26
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04527484. Inclusion in this directory is not an endorsement.