A Randomized, Double-blind, Two-arm, Parallel-group, Single-dose, Phase 1 Study to Compare the Pharmacokinetics, Safety, and Immunogenicity of Subcutaneous CT-P6 and Herceptin in Healthy Male Subjects
CT-P6 SC, containing the active substance trastuzumab in combination with rHuPH20, is being developed by CELLTRION, Inc. (hereafter, the Sponsor) as a proposed biosimilar to the reference product, EU-approved Herceptin SC. The primary amino acid sequences of trastuzumab in CT-P6 SC are identical to those of the reference drug (EU-approved Herceptin SC). The CT P6 drug product will have the same pharmaceutical liquid formulation form and strength as the reference product's vial for SC injection and is intended to have a highly similar quality profile to the reference product.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
200
A single fixed dose (600 mg) of CT-P6 subcutaneous
A single fixed dose (600 mg) of EU-approved Herceptin subcutaneous
Celltrion
Yeonsu-gu, Incheon, South Korea
Demonstrate PK similarity
maximum serum concentration (Cmax) of CT-P6 SC to EU-approved Herceptin SC
Time frame: Up to Day 64
Demonstrate PK similarity
area under the concentration-time curve from time zero to infinity (AUC0-inf) of CT-P6 SC to EU-approved Herceptin SC
Time frame: Up to Day 64
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