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A Randomized, Double-blinded, Active Controlled Crossover Clinical Trial to Investigate PK, PD and Safety of GBPD002

NCT05585658 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2022-10-20

No results posted yet for this study

Summary

Erythropoietin (EPO) biosimilarity for GBPD002 (test candidate) and Eprex® (comparator) has been evaluated by comparing the pharmacokinetic (PK) and pharmacodynamic (PD) properties following subcutaneous injection in human subjects. This was a randomized, double-blind, two-sequence, crossover study. Subjects were randomly assigned and received a dose (4,000 IU) of either the test or comparator EPO. The subjects received the alternative formulation after the wash out period (4 weeks) of the first administration. The primary PK parameters, viz., maximum observed concentration (Cmax) and area under the curve extrapolated to infinity (AUC00-inf), were calculated with the serum EPO concentrations from blood samples and were found comparable for both formulations. The geometric mean ratios (@90% CI) of the Cmax and AUCinf were 1.16 and 0.89, respectively, which were within the regulatory range of 0.80-1.25. The reticulocyte, hematocrit, hemoglobin and red blood cell counts were measured as PD markers. The time-matched serum EPO concentrations and PD markers denoted a counterclockwise hysteresis, and thereby suggesting a time delay between the observed concentration and the response. ANOVA derived P-values (all were greater than 0.05) for the effectors clearly revealed the similarity between effects on PD markers for both formulations. Both formulations were found tolerated well, and anti-drug antibodies were not observed. Thus, the two formulations are projected to be used interchangeably in clinical settings.

Conditions

  • Natural Blood and Blood Product Toxicity

Interventions

BIOLOGICAL

Erythropoietin alpha

To analyze bio-similarity of GBPD002 with Eprex®, the Globe Biotech Ltd performed quite a few experiments to determine total analytical study of GBPD002. They performed peptide mapping to determine amino acid composition of GBPD002 and found similar result with erythropoietin alpha. The molecular weight was determined through SDS-PAGE analysis of GBPD002 and was compared with Eprex. The western blot analysis was performed to determine immune chemical characterization. Characterization of different isoforms was conducted through 2D gel electrophoresis.

Sponsors & Collaborators

  • Globe Biotech Limited

    lead INDUSTRY

Principal Investigators

  • Mamun Al Mahtab, PhD · Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2021-10-16
Primary Completion
2021-11-14
Completion
2021-12-16

Countries

  • Bangladesh

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 NCT05585658 on ClinicalTrials.gov