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REGN3048Wiki

Developed by Shray Alag
Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation


Correlated Drug Terms (3)

Name (Synonyms) Correlation
drug1500 Ivermectin Tablets Wiki 1.00
drug2339 REGN3051 Wiki 1.00
drug2122 Placebo Wiki 0.05

Correlated MeSH Terms (2)

Name (Synonyms) Correlation
D045169 Severe Acute Respiratory Syndrome NIH 0.05
D018352 Coronavirus Infections NIH 0.04

Correlated HPO Terms (0)

Name (Synonyms) Correlation

There is one clinical trial.

Clinical Trials

1 A Phase I Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Immunogenicity of Co-administered MERS-CoV Antibodies REGN3048 and REGN3051 vs. Placebo in Healthy Adults

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 Corona Virus Infection Other: Placebo Biological: REGN3048 Biological: REGN3051
MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

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

No related HPO nodes (Using clinical trials)