Pharmacokinetics, Safety and Tolerability Study of Single Dose of Abatacept 125mg Administered Subcutaneously
NCT02805010 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 22
Last updated 2016-12-06
Summary
The objective of the study is to assess the single dose PK, safety, tolerability and immunogenicity of abatacept 125mg administered SC in Chinese healthy subjects.
Conditions
- Rheumatoid Arthritis (RA)
Interventions
- DRUG
-
On Day 1, subjects will receive a single SC dose of abatacept 125mg
- OTHER
-
Placebo
On Day 1, subjects will receive a single SC dose of placebo
Sponsors & Collaborators
- collaborator INDUSTRY
-
Jiangsu Simcere Pharmaceutical Co., Ltd.
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 45 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2016-10-31
- Primary Completion
- 2017-02-28
- Completion
- 2017-02-28
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