NCT03659305

Pharmacokinetic Equivalence and Safety Study of RPH-001 and Avastin®

Double-blind Randomized Comparative, in Parallel Groups, Clinical Study of Pharmacokinetics and Safety of Drugs RPH-001 (JSC R-Pharm, Russia) and Avastin® (F. Hoffmann-La Roche Ltd, Switzerland) in Single Intravenous Administration in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: R-Pharm · Industry
• Sex: Male
• Age: 21 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to confirm pharmacokinetic equivalence and compare clinical safety profile of RPH-001 and Avastin®.

Detailed description

The study will be conducted in one specialized clinical site in Russia. It is planned to randomize 80 healthy male volunteers in this study. After screening period, not exceeding 15 days, all eligible subjects will be hospitalized to the site and randomized to receive RPH-001 or Avastin in 1:1 ratio. After a single-dose of investigational drugs administration subjects will remain under the observation in clinical site for 8 days and then will be discharged. The out-patient follow up period will include at least 8 scheduled subject's visits to the site. The study will consider completed for each subject at Day 100 visit after all clinical study procedures completion.

Conditions

• Healthy

Interventions

Type	Name	Description
BIOLOGICAL	RPH-001	Concentrate for preparation solution for infusion in ampules, 25 mg/mL
BIOLOGICAL	Avastin	Concentrate for preparation solution for infusion in ampules, 25 mg/mL

Timeline

• Start date: 2018-07-10
• Primary completion: 2019-01-26
• Completion: 2019-01-26
• First posted: 2018-09-06
• Last updated: 2019-02-05

Locations

1 site across 1 country: Russia