To Compare the Pharmacokinetics, Safety and Immunogenicity of CT-P55 and Cosentyx in Healthy Subjects

Celltrion Healthcare

Status and phase: Completed; Phase 1

Conditions: Healthy Male Subjects

Treatments: Biological: CT-P55; Biological: US-licensed Cosentyx; Biological: EU-approved Cosentyx

Study type: Interventional

Funder types: Industry

Identifiers

NCT07054970

CT-P55 1.1

Details and patient eligibility

About

This is a Phase 1, Randomized, Double-blind, three-arm, Parallel group, Single-dose Study to Compare the Pharmacokinetics, Safety and immunogenicity of CT-P55, EU-approved Cosentyx and US-licensed Cosentyx in Healthy male Subjects

Full description

CT-P55, containing the active ingredient secukinumab, is being developed by CELLTRION, Inc. as a proposed biosimilar to the reference product, Cosentyx. In this study, Pharmacokinetics, Safety and Immunogenicity of CT-P55, EU-approved Cosentyx and US-licensed Cosentyx were evaluated in Healthy Male Subjects.

Enrollment: 172 patients

Sex: Male

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy male subjects between the ages of 18 and 55 years, both inclusive.
• Body weight between 50.0 kg and 90.0 kg (both inclusive), and Body Mass Index (BMI) between 18.5 and 29.9 kg/m2 (both inclusive), when rounded to the nearest tenth.

Exclusion criteria

• A medical history and/or condition that is considered significant
• Clinically significant allergic reactions, hypersensitivity
• History or current infection of human immunodeficiency virus, hepatitis B virus, hepatitis C virus or syphilis
• Active or latent Tuberculosis
• History of malignancy
• Previous monoclonal antibody or fusion protein treatment, or current use of any biologics
• Planning to be father a child or donate sperm within 22 weeks period following study drug administration.
• Undergone treatment with an investigational drug or participated in another clinical trial within 12weeks or 5 half-lives (whichever is longer)

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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172 participants in 3 patient groups

CT-P55

Experimental group

Description:

a single subcutaneous (SC) injection via pre-filled syringe (PFS)

Treatment:

Biological: CT-P55

US-licensed Cosentyx

Active Comparator group

Description:

a single SC injection via PFS

Treatment:

Biological: US-licensed Cosentyx

EU-approved Cosentyx

Active Comparator group

Description:

a single SC injection via PFS

Treatment:

Biological: EU-approved Cosentyx