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Clinical Trials/NCT04175158
NCT04175158
Unknown
Phase 1

A Randomized, Double-blind, Parallel-controlled Comparative Study to Evaluate the PK Pharmacokinetic Similarity After Single Administration of GB222 and Bevacizumab in Healthy Volunteers.

Genor Biopharma Co., Ltd.1 site in 1 country84 target enrollmentApril 24, 2017
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ConditionsNon-small Cell Lung Cancer

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Non-small Cell Lung Cancer
Sponsor
Genor Biopharma Co., Ltd.
Enrollment
84
Locations
1
Primary Endpoint
AUC 0- t
Last Updated
6 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief Summary

The primary objective of this study is to evaluate the similarity of the primary pharmacokinetic (PK) parameter AUC0-t of GB222 and bevacizumab after single administration; the secondary objective is to observe the safety and similarities and safety of other pharmacokinetic (PK) parameters (Cmax, AUC0-∞ etc.) and immunogenicity of GB222 and bevacizumab after single administration.

Registry
clinicaltrials.gov
Start Date
April 24, 2017
End Date
November 2020
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Male

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

AUC 0- t

Time Frame: Up to 84 days

AUC 0- t

Secondary Outcomes

  • Cmax(Up to 84 days)
  • AUC0-∞(Up to 84 days)
  • ADA(Up to 84 days)

Study Sites (1)

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