drugset / Trial / NCT02107872
Study to Assess the Safety and Tolerability of Multiple Ascending Doses of REGN1500
RandomizedSingle-groupQuadruple-blindTreatment
Summary
This is a phase 1, randomized, double-blind, placebo-controlled, multiple ascending dose study to assess the safety, tolerability, pharmacokinetic (PK), immunogenicity, and pharmacodynamic (PD) effects of REGN1500 in patients with a metabolic disorder.
Timeline
- Start
- 2014-04
- Primary completion
- 2015-09
- Completion
- 2015-09
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Evinacumab | Monoclonal antibody | 20 mg/kg | Subcutaneous |
| Subject | Evinacumab | Monoclonal antibody | 150 mg | Subcutaneous |
| Subject | Evinacumab | Monoclonal antibody | 300 mg | Subcutaneous |
| Subject | Evinacumab | Monoclonal antibody | 450 mg | Subcutaneous |