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.
NCT03301090 Conditions
- Corona Virus Infection
Interventions
- Other: Placebo
- Biological: REGN3048
- Biological: REGN3051
Primary Outcomes
Measure: Changes from baseline in abbreviated physical examination Time: Days 1-2
Measure: Changes from baseline in clinical safety laboratory values Time: From Day 2 up to Day 121
Measure: Changes from baseline in Electrocardiogram (ECG) parameters Time: 15 mins after infusion
Measure: Changes from baseline in Electrocardiogram (ECG) parameters Time: 24 hrs after infusion
Measure: Changes from baseline in symptom-directed physical examination Time: From Day 1 up to Day 121
Measure: Changes from baseline in vital signs Time: From Day 1 up to Day 121
Measure: The incidence of Adverse Events Time: From Day 1 up to Day 121
Measure: The incidence of treatment-emergent Serious Adverse Events Time: From Day 1 up to Day 121
Measure: The severity of Adverse Events assessed by toxicity grading criteria Time: From Day 1 up to Day 121
Measure: The severity of treatment-emergent Serious Adverse Events assessed by toxicity grading criteria Time: From Day 1 up to Day 121
Measure: The type of treatment-emergent Serious Adverse Events Time: From Day 1 up to Day 121
Secondary Outcomes
Measure: AUC for each dose of REGN3048 measured using validated Enzyme Linked Immunosorbent Assays (ELISAs) Time: From Day 1 up to Day 121
Measure: AUC for each dose of REGN3051 measured using validated Enzyme Linked Immunosorbent Assays (ELISAs) Time: From Day 1 up to Day 121
Measure: AUC(0-infinity) for each dose of REGN3048 measured using validated Enzyme Linked Immunosorbent Assays (ELISAs) Time: From Day 1 up to Day 121
Measure: AUC(0-infinity) for each dose of REGN3051 measured using validated Enzyme Linked Immunosorbent Assays (ELISAs) Time: From Day 1 up to Day 121
Measure: CL for each dose of REGN3048 measured using validated Enzyme Linked Immunosorbent Assays (ELISAs) Time: From Day 1 up to Day 121
Measure: CL for each dose of REGN3051 measured using validated Enzyme Linked Immunosorbent Assays (ELISAs) Time: From Day 1 up to Day 121
Measure: CMAX for each dose of REGN3048 measured using validated Enzyme Linked Immunosorbent Assays (ELISAs) Time: From Day 1 up to Day 121
Measure: CMAX for each dose of REGN3051 measured using validated Enzyme Linked Immunosorbent Assays (ELISAs) Time: From Day 1 up to Day 121
Measure: K(e) for each dose of REGN3048 measured using validated Enzyme Linked Immunosorbent Assays (ELISAs) Time: From Day 1 up to Day 121
Measure: K(e) for each dose of REGN3051 measured using validated Enzyme Linked Immunosorbent Assays (ELISAs) Time: From Day 1 up to Day 121
Measure: t(1/2) for each dose of REGN3048 measured using validated Enzyme Linked Immunosorbent Assays (ELISAs) Time: From Day 1 up to Day 121
Measure: t(1/2) for each dose of REGN3051 measured using validated Enzyme Linked Immunosorbent Assays (ELISAs) Time: From Day 1 up to Day 121
Measure: The change from baseline of antibodies against REGN3048 and REGN3051 (anti-drug antibodies, ADA), as measured in serum using validated bridging assays Time: Day 121
Measure: The change from baseline of antibodies against REGN3048 and REGN3051 (anti-drug antibodies, ADA), as measured in serum using validated bridging assays Time: Day 57
Measure: TMAX for each dose of REGN3048 measured using validated Enzyme Linked Immunosorbent Assays (ELISAs) Time: From Day 1 up to Day 121
Measure: TMAX for each dose of REGN3051 measured using validated Enzyme Linked Immunosorbent Assays (ELISAs) Time: From Day 1 up to Day 121
Measure: V(ss) for each dose of REGN3048 measured using validated Enzyme Linked Immunosorbent Assays (ELISAs) Time: From Day 1 up to Day 121
Measure: V(ss) for each dose of REGN3051 measured using validated Enzyme Linked Immunosorbent Assays (ELISAs) Time: From Day 1 up to Day 121
