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.
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. Secondary Objectives: 1) To assess the pharmacokinetic (PK) profiles of REGN3048 and REGN3051 following co-administration of single IV doses (1.5, 5, 15, 25, 50, and 75 mg/kg of each of the two mAb's); 2) To assess the immunogenicity of REGN3048 and REGN3051 following co-administration of single IV doses (1.5, 5, 15, 25, 50, and 75 mg/kg of each of the two mAb's)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
48
Placebo
REGN3048 is a fully monoclonal antibody (mAbs) which binds to the S protein of MERS-CoV.
REGN3051 is a fully human monoclonal antibody (mAb) which binds to the S protein of MERS-CoV. It can reduce virus titers and ameliorate MERS-CoV-induced lung pathology when given post infection.
WCCT Global Cypress Clinical Pharmacology Unit
Cypress, California, United States
Changes from baseline in abbreviated physical examination
Time frame: Days 1-2
Changes from baseline in clinical safety laboratory values
Time frame: From Day 2 up to Day 121
Changes from baseline in Electrocardiogram (ECG) parameters
Time frame: 15 mins after infusion
Changes from baseline in Electrocardiogram (ECG) parameters
Time frame: 24 hrs after infusion
Changes from baseline in symptom-directed physical examination
Time frame: From Day 1 up to Day 121
Changes from baseline in vital signs
Time frame: From Day 1 up to Day 121
The incidence of Adverse Events
Time frame: From Day 1 up to Day 121
The incidence of treatment-emergent Serious Adverse Events
Time frame: From Day 1 up to Day 121
The severity of Adverse Events assessed by toxicity grading criteria
Time frame: From Day 1 up to Day 121
The severity of treatment-emergent Serious Adverse Events assessed by toxicity grading criteria
Time frame: From Day 1 up to Day 121
The type of treatment-emergent Serious Adverse Events
Time frame: From Day 1 up to Day 121
AUC for each dose of REGN3048 measured using validated Enzyme Linked Immunosorbent Assays (ELISAs)
Time frame: From Day 1 up to Day 121
AUC for each dose of REGN3051 measured using validated Enzyme Linked Immunosorbent Assays (ELISAs)
Time frame: From Day 1 up to Day 121
AUC(0-infinity) for each dose of REGN3048 measured using validated Enzyme Linked Immunosorbent Assays (ELISAs)
Time frame: From Day 1 up to Day 121
AUC(0-infinity) for each dose of REGN3051 measured using validated Enzyme Linked Immunosorbent Assays (ELISAs)
Time frame: From Day 1 up to Day 121
CL for each dose of REGN3048 measured using validated Enzyme Linked Immunosorbent Assays (ELISAs)
Time frame: From Day 1 up to Day 121
CL for each dose of REGN3051 measured using validated Enzyme Linked Immunosorbent Assays (ELISAs)
Time frame: From Day 1 up to Day 121
CMAX for each dose of REGN3048 measured using validated Enzyme Linked Immunosorbent Assays (ELISAs)
Time frame: From Day 1 up to Day 121
CMAX for each dose of REGN3051 measured using validated Enzyme Linked Immunosorbent Assays (ELISAs)
Time frame: From Day 1 up to Day 121
K(e) for each dose of REGN3048 measured using validated Enzyme Linked Immunosorbent Assays (ELISAs)
Time frame: From Day 1 up to Day 121
K(e) for each dose of REGN3051 measured using validated Enzyme Linked Immunosorbent Assays (ELISAs)
Time frame: From Day 1 up to Day 121
t(1/2) for each dose of REGN3048 measured using validated Enzyme Linked Immunosorbent Assays (ELISAs)
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Time frame: From Day 1 up to Day 121
t(1/2) for each dose of REGN3051 measured using validated Enzyme Linked Immunosorbent Assays (ELISAs)
Time frame: From Day 1 up to Day 121
The change from baseline of antibodies against REGN3048 and REGN3051 (anti-drug antibodies, ADA), as measured in serum using validated bridging assays
Time frame: Day 121
The change from baseline of antibodies against REGN3048 and REGN3051 (anti-drug antibodies, ADA), as measured in serum using validated bridging assays
Time frame: Day 57
TMAX for each dose of REGN3048 measured using validated Enzyme Linked Immunosorbent Assays (ELISAs)
Time frame: From Day 1 up to Day 121
TMAX for each dose of REGN3051 measured using validated Enzyme Linked Immunosorbent Assays (ELISAs)
Time frame: From Day 1 up to Day 121
V(ss) for each dose of REGN3048 measured using validated Enzyme Linked Immunosorbent Assays (ELISAs)
Time frame: From Day 1 up to Day 121
V(ss) for each dose of REGN3051 measured using validated Enzyme Linked Immunosorbent Assays (ELISAs)
Time frame: From Day 1 up to Day 121