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Biosimilarity Study of Intravenous Recombinant Human Erythropoietin in Healthy Volunteers

NCT04954989 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2024-08-21

No results posted yet for this study

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

Conditions

  • Healthy

Interventions

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

Sponsors & Collaborators

  • Megalabs

    lead INDUSTRY

Principal Investigators

  • Satish Kumar, MD · Azidus Principal Investigator

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-10-06
Primary Completion
2024-12-01
Completion
2024-12-31

Countries

  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04954989 on ClinicalTrials.gov