A Study to Compare Pharmacokinetic and Safety of TRS003 to China-approved Bevacizumab and US-licensed Avastin®

Part of paid clinical trials in Cypress, California.

Sponsor
Zhejiang Teruisi Pharmaceutical Inc.
Study ID
NCT03882424
Phase
PHASE1
Status
Completed

Conditions

  • Healthy

Eligibility Criteria

Sex
MALE
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • TRS003 — BIOLOGICAL
    25mg/mL (4 mL/vial) Injection，Single dose of 3mg/kg Intravenous infusion for 90 minutes
  • China-approved Bevacizumab — BIOLOGICAL
    25mg/mL (4 mL/vial) Injection，Single dose of 3mg/kg Intravenous infusion for 90 minutes
  • US-licensed Avastin — BIOLOGICAL
    25mg/mL (4 mL/vial) Injection，Single dose of 3mg/kg Intravenous infusion for 90 minutes

Study Details

This is a 12-week, randomized, double-blind, single-dose pharmacokinetic (PK) study. Approximately 114 healthy male participants (screening occurred within 28 days prior to dosing) will be randomized 1:1:1 to either TRS003, China-approved bevacizumab, and US-licensed Avastin® groups. Study drug will be dispensed as a single 3 mg/kg dose for intravenous infusion within 90 minutes. PK and immunogenicity samples will be collected and safety will be assessed. The primary objective of this study was to demonstrate pharmacokinetic similarity between TRS003, China-approved bevacizumab and US-licensed Avastin®, as measured by AUC0-inf in healthy male participants after a single 3 mg/kg dose.

Key Dates

First listed
Mar 20, 2019
Start date
Jun 12, 2018
Status verified
Jun 2020
Primary completion
Sep 30, 2018
Completion
Oct 25, 2018

Study Design

Enrollment
114 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Experimental: TRS003
    Proposed biosimilar of bevacizumab，Intravenous administration
  • Active Comparator: China-approved Bevacizumab
    Intravenous administration
  • Active Comparator: US-licensed Avastin
    Intravenous administration

Primary Outcome Measure

AUC0-inf，Area Under the Serum Concentration Versus Time Curve，Time 0 to Infinity [ Time Frame: Pre-dose, 0 hour (End of infusion, EOI), 0.5 hour, 4 hours, 8 hours, 24 hours, 48 hours, 96 hours, 168 hours, 336 hours, 672 hours, 1008 hours, 1344 hours, 1680 hours, and 2016 hours post EOI ]

Locations (1)

FacilityCityStateZIPSite coordinators
WCCT Global, Inc.CypressCalifornia90630-

Find similar trials in Cypress, CA

By research site
WCCT Global, Inc.· Cypress, CA

Related Studies