NCT04954989

Biosimilarity Study of Intravenous Recombinant Human Erythropoietin in Healthy Volunteers

Phase I Open and Monocentric Clinical Trial With Pharmacokinetic and Pharmacodynamic Determination of Intravenous Recombinant Human Erythropoietin in Male Adults.

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 52 (estimated)
• Sponsor: Megalabs · Industry
• Sex: Male
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

Open label and monocentric Phase I Clinical Trial, to Determine the Pharmacokinetics and Pharmacodynamics of Recombinant Human Erythropoietin for Subcutaneous Use in an Adult Male Population

Detailed description

An open label, balanced, randomized, two treatments, two sequences, two periods, single dose, crossover design will be used to study the pharmacokinetics and pharmacodynamics of two different rHuEpo products when administered subcutaneously in healthy subjects. PK parameters to evaluate shall be AUCt and AUCt to infinity, and Cmax PD parameter shall be erithrocye and reticulocyte counts and hematocrite. Bioequivalence shall be evaluated according to 80-125 T/R rate for 90 % Cmax and AUC for pk and PD parameters.

Conditions

• Healthy

Interventions

Type	Name	Description
BIOLOGICAL	Experimental Erythropoietin subcutaneous injection single dose of 4,000 IU	Recombinant Human Erythropoietin: single dose of 4,000 IU (syringe filled with 0.4 mL with 4,000 IU) of the experimental drug should be administered subcutaneously
BIOLOGICAL	Active comparator Erythropoietin subcutaneous injection single dose of 4,000 IU	Recombinant Human Erythropoietin: single dose of 4,000 IU (syringe filled with 0.4 mL with 4,000 IU) should be administered subcutaneously

Timeline

• Start date: 2024-10-06
• Primary completion: 2024-12-01
• Completion: 2024-12-01
• First posted: 2021-07-08
• Last updated: 2024-08-21

Locations

1 site across 1 country: India