A Safety, Tolerability, Pharmacokinetics and Immunogenicity Trial of Co-administered MERS-CoV Antibodies REGN3048 and REGN3051
Summary
This is a Phase 1, first-in-human (FIH), single site, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, pharmacokinetics (PK), and immunogenicity of single ascending doses of a co-administered (1:1, w/w) combination of REGN3048 and REGN3051 mAb's, administered IV in healthy adult volunteers. Study duration of approximately 16 months. Approximately 48 evaluable subjects will be enrolled in the study, eight (8) subjects in each one of 6 sequential ascending IV dose cohorts. In each cohort, subjects will be randomized to receive mAb's REGN3048 and REGN3051 (6 subjects) or placebo (2 subjects). Primary Objective: To assess the safety and tolerability of REGN3048 and REGN3051 following co-administration of single, ascending IV doses of 1.5, 5, 15, 25, 50, and 75 mg/kg of each of the two mAb's.
Timeline
- Start
- 2018-02-12
- Primary completion
- 2019-01-19
- Completion
- 2019-01-19
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | REGN3048 | Monoclonal antibody | 1.5 mg/kg | Intravenous |
| Subject | REGN3048 | Monoclonal antibody | 5 mg/kg | Intravenous |
| Subject | REGN3048 | Monoclonal antibody | 15 mg/kg | Intravenous |
| Subject | REGN3048 | Monoclonal antibody | 25 mg/kg | Intravenous |
| Subject | REGN3048 | Monoclonal antibody | 50 mg/kg | Intravenous |
| Subject | REGN3048 | Monoclonal antibody | 75 mg/kg | Intravenous |
| Subject | REGN3051 | Monoclonal antibody | 1.5 mg/kg | Intravenous |
| Subject | REGN3051 | Monoclonal antibody | 5 mg/kg | Intravenous |
| Subject | REGN3051 | Monoclonal antibody | 15 mg/kg | Intravenous |
| Subject | REGN3051 | Monoclonal antibody | 25 mg/kg | Intravenous |
| Subject | REGN3051 | Monoclonal antibody | 50 mg/kg | Intravenous |
| Subject | REGN3051 | Monoclonal antibody | 75 mg/kg | Intravenous |