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MepolizumabWiki

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


Correlated Drug Terms (4)

Name (Synonyms) Correlation
drug1373 Lopinavir/ritonavir treatment Wiki 0.50
drug1358 Lopinavir / ritonavir tablets combined with Xiyanping injection Wiki 0.50
drug2078 Reslizumab Wiki 0.25
drug1822 Placebo Wiki 0.03

Correlated MeSH Terms (3)

Name (Synonyms) Correlation
D011014 Pneumonia NIH 0.03
D045169 Severe Acute Respiratory Syndrome NIH 0.03
D018352 Coronavirus Infections NIH 0.02

Correlated HPO Terms (1)

Name (Synonyms) Correlation
HP:0002090 Pneumonia HPO 0.03

There are 4 clinical trials

Clinical Trials

1 Pharmacodynamic Biomarkers to Support Biosimilar Development: Clinical Study 1: Interleukin-5 Antagonists - Mepolizumab and Reslizumab

This study is designed to assess pharmacokinetics and pharmacodynamics of mepolizumab and reslizumab across an appropriate dose range to inform clinical trial operating characteristics for future clinical pharmacology pharmacodynamics similarity studies. This is a randomized, placebo-controlled, single-dose, parallel arm study in 72 healthy subjects assigned to one of four dose groups (low, intermediate low, intermediate high, and high) of each drug (mepolizumab or reslizumab) or placebo.

NCT04183192 Healthy Subjects Pharmacokinetics Pharmacodynamics Biological: Mepolizumab Biological: Mepolizumab Biological: Mepolizumab Biological: Mepolizumab Biological: Reslizumab Biological: Reslizumab Biological: Reslizumab Biological: Reslizumab Biological: Placebo

Primary Outcomes

Description: 1. The values and variability of standard pharmacodynamic metrics (AUEC and maximal difference at a single time-point) for eosinophils at low, intermediate low, intermediate high, and high doses of mepolizumab and reslizumab

Measure: Area under effect curve and maximum change from baseline for eosinophils for mepolizumab and reslizumab

Time: 63 or 123 days, depending on treatment arm

Secondary Outcomes

Description: 1. The values and variability of pharmacokinetic characteristics (Cmax and area under the curve of free drug concentration) at low, intermediate low, intermediate high, and high doses of mepolizumab and reslizumab.

Measure: Maximum concentration and area under the curve for mepolizumab and reslizumab

Time: 63 or 123 days, depending on treatment arm

Description: 2. Parameters (Emax, and EC50) calculated by the model after combining data from low, intermediate low, intermediate high, and high doses of mepolizumab or reslizumab with placebo data.

Measure: Pharmacodynamic model parameters for mepolizumab and reslizumab

Time: 63 or 123 days, depending on treatment arm

2 Pharmacodynamic Biomarkers to Support Biosimilar Development: Clinical Study 1: Interleukin-5 Antagonists - Mepolizumab and Reslizumab

This study is designed to assess pharmacokinetics and pharmacodynamics of mepolizumab and reslizumab across an appropriate dose range to inform clinical trial operating characteristics for future clinical pharmacology pharmacodynamics similarity studies. This is a randomized, placebo-controlled, single-dose, parallel arm study in 72 healthy subjects assigned to one of four dose groups (low, intermediate low, intermediate high, and high) of each drug (mepolizumab or reslizumab) or placebo.

NCT04183192 Healthy Subjects Pharmacokinetics Pharmacodynamics Biological: Mepolizumab Biological: Mepolizumab Biological: Mepolizumab Biological: Mepolizumab Biological: Reslizumab Biological: Reslizumab Biological: Reslizumab Biological: Reslizumab Biological: Placebo

Primary Outcomes

Description: 1. The values and variability of standard pharmacodynamic metrics (AUEC and maximal difference at a single time-point) for eosinophils at low, intermediate low, intermediate high, and high doses of mepolizumab and reslizumab

Measure: Area under effect curve and maximum change from baseline for eosinophils for mepolizumab and reslizumab

Time: 63 or 123 days, depending on treatment arm

Secondary Outcomes

Description: 1. The values and variability of pharmacokinetic characteristics (Cmax and area under the curve of free drug concentration) at low, intermediate low, intermediate high, and high doses of mepolizumab and reslizumab.

Measure: Maximum concentration and area under the curve for mepolizumab and reslizumab

Time: 63 or 123 days, depending on treatment arm

Description: 2. Parameters (Emax, and EC50) calculated by the model after combining data from low, intermediate low, intermediate high, and high doses of mepolizumab or reslizumab with placebo data.

Measure: Pharmacodynamic model parameters for mepolizumab and reslizumab

Time: 63 or 123 days, depending on treatment arm

3 Pharmacodynamic Biomarkers to Support Biosimilar Development: Clinical Study 1: Interleukin-5 Antagonists - Mepolizumab and Reslizumab

This study is designed to assess pharmacokinetics and pharmacodynamics of mepolizumab and reslizumab across an appropriate dose range to inform clinical trial operating characteristics for future clinical pharmacology pharmacodynamics similarity studies. This is a randomized, placebo-controlled, single-dose, parallel arm study in 72 healthy subjects assigned to one of four dose groups (low, intermediate low, intermediate high, and high) of each drug (mepolizumab or reslizumab) or placebo.

NCT04183192 Healthy Subjects Pharmacokinetics Pharmacodynamics Biological: Mepolizumab Biological: Mepolizumab Biological: Mepolizumab Biological: Mepolizumab Biological: Reslizumab Biological: Reslizumab Biological: Reslizumab Biological: Reslizumab Biological: Placebo

Primary Outcomes

Description: 1. The values and variability of standard pharmacodynamic metrics (AUEC and maximal difference at a single time-point) for eosinophils at low, intermediate low, intermediate high, and high doses of mepolizumab and reslizumab

Measure: Area under effect curve and maximum change from baseline for eosinophils for mepolizumab and reslizumab

Time: 63 or 123 days, depending on treatment arm

Secondary Outcomes

Description: 1. The values and variability of pharmacokinetic characteristics (Cmax and area under the curve of free drug concentration) at low, intermediate low, intermediate high, and high doses of mepolizumab and reslizumab.

Measure: Maximum concentration and area under the curve for mepolizumab and reslizumab

Time: 63 or 123 days, depending on treatment arm

Description: 2. Parameters (Emax, and EC50) calculated by the model after combining data from low, intermediate low, intermediate high, and high doses of mepolizumab or reslizumab with placebo data.

Measure: Pharmacodynamic model parameters for mepolizumab and reslizumab

Time: 63 or 123 days, depending on treatment arm

4 Pharmacodynamic Biomarkers to Support Biosimilar Development: Clinical Study 1: Interleukin-5 Antagonists - Mepolizumab and Reslizumab

This study is designed to assess pharmacokinetics and pharmacodynamics of mepolizumab and reslizumab across an appropriate dose range to inform clinical trial operating characteristics for future clinical pharmacology pharmacodynamics similarity studies. This is a randomized, placebo-controlled, single-dose, parallel arm study in 72 healthy subjects assigned to one of four dose groups (low, intermediate low, intermediate high, and high) of each drug (mepolizumab or reslizumab) or placebo.

NCT04183192 Healthy Subjects Pharmacokinetics Pharmacodynamics Biological: Mepolizumab Biological: Mepolizumab Biological: Mepolizumab Biological: Mepolizumab Biological: Reslizumab Biological: Reslizumab Biological: Reslizumab Biological: Reslizumab Biological: Placebo

Primary Outcomes

Description: 1. The values and variability of standard pharmacodynamic metrics (AUEC and maximal difference at a single time-point) for eosinophils at low, intermediate low, intermediate high, and high doses of mepolizumab and reslizumab

Measure: Area under effect curve and maximum change from baseline for eosinophils for mepolizumab and reslizumab

Time: 63 or 123 days, depending on treatment arm

Secondary Outcomes

Description: 1. The values and variability of pharmacokinetic characteristics (Cmax and area under the curve of free drug concentration) at low, intermediate low, intermediate high, and high doses of mepolizumab and reslizumab.

Measure: Maximum concentration and area under the curve for mepolizumab and reslizumab

Time: 63 or 123 days, depending on treatment arm

Description: 2. Parameters (Emax, and EC50) calculated by the model after combining data from low, intermediate low, intermediate high, and high doses of mepolizumab or reslizumab with placebo data.

Measure: Pharmacodynamic model parameters for mepolizumab and reslizumab

Time: 63 or 123 days, depending on treatment arm

No related HPO nodes (Using clinical trials)