Study Comparing TPI-120 and Neulasta Administered Through Subcutaneous Route in Healthy Adult Subjects — TPI-120  

Healthy Volunteers Clinical Trial

Official title: A Randomized, Double Blind, Single-Dose, Two-Period Crossover Comparative Pharmacology Study Comparing TPI-120 and Neulasta® Administered Through Subcutaneous Route in Healthy Adult Subjects

Status Completed

Clinical Trial Summary

This is a single or up to 2 centers, double-blind, randomized, single-dose, two-way, crossover study comparing the Test (T) and Reference (R) products following subcutaneous administration. Subjects will be randomly assigned to one of two treatments sequences (TR or RT).

All subjects will be dosed at the CRO's designated clinical site(s) and the same protocol requirements and procedures will be followed within each group.

Clinical Trial Description

The current study design was prepared to assess and compare the PK, PD, safety, tolerability of the Adello biosimilar candidate, TPI-120 and the US-licensed reference product, Neulasta® after administering a single subcutaneous 2 mg dose in healthy adult subjects in a crossover design. The primary PK parameters are AUC0-t, AUC0-inf, and Cmax, and the primary PD parameters are baseline-corrected AUEC0-t and Emax for ANC.

This is a single or up to 2 centers, double-blind, randomized, single-dose, two-way, crossover study comparing the Test (T) and Reference (R) products following subcutaneous administration. Subjects will be randomly assigned to one of two treatments sequences (TR or RT).

All subjects will be dosed at the CRO's designated clinical site(s) and the same protocol requirements and procedures will be followed within each group. ;

Related Conditions & MeSH terms

• Healthy Volunteers

• NCT number: NCT03206229
• Study type: Interventional
• Source: Adello Biologics, LLC
• Status: Completed
• Phase: Phase 1
• Start date: February 13, 2017
• Completion date: January 18, 2018