drugset / Trial / NCT02460393
A Trial With Humanized TNFα Monoclonal Antibody Injection by Single Dose and Dose Escalation in Healthy Subjects
RandomizedParallel-groupDouble-blindTreatment
Summary
This study is a randomized, double-blind and placebo-controlled trial with healthy subjects. There are 6 Groups as follows: 5mg, 15mg, 30mg, 50mg, 75mg, 100mg, and each group includes12 people. A single subcutaneous injection will be administrated starting from the low dose group (in accordance with 5mg, 15mg, 30mg, 50mg, 75mg, 100mg administered subcutaneously). Pharmacokinetics and pharmacodynamics data will be collected; drug metabolism and pharmacokinetics characteristics will be analyzed. Drug safety and tolerance for subjects will be evaluated.
Timeline
- Start
- 2015-05
- Primary completion
- 2015-11
- Completion
- 2015-11
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Humanized TNFα monoclonal antibody | Monoclonal antibody | 5 mg | Subcutaneous |
| Subject | Humanized TNFα monoclonal antibody | Monoclonal antibody | 15 mg | Subcutaneous |
| Subject | Humanized TNFα monoclonal antibody | Monoclonal antibody | 30 mg | Subcutaneous |
| Subject | Humanized TNFα monoclonal antibody | Monoclonal antibody | 50 mg | Subcutaneous |
| Subject | Humanized TNFα monoclonal antibody | Monoclonal antibody | 75 mg | Subcutaneous |
| Subject | Humanized TNFα monoclonal antibody | Monoclonal antibody | 100 mg | Subcutaneous |