A Study to Compare the Auto-injector and Pre-filled Syringe of CT-P43 in Healthy Male Subjects

Celltrion162 enrolled

Overview

This is phase 1 study to Compare the Pharmacokinetics, Safety and Immunogenicity of the Auto-injector and Pre-filled syringe of CT-P43 in Healthy Male Subjects.

CT-P43, containing the active ingredient ustekinumab, is being developed by CELLTRION, Inc. as a proposed biosimilar to the reference product, Stelara. In this study, Pharmacokinetics, Safety and Immunogenicity of the Auto-injector and Pre-filled syringe of CT-P43 will be evaluated in Healthy Male Subjects.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

162

Conditions

Healthy Male Subjects

Interventions

CT-P43BIOLOGICAL

CT-P43, 45 mg in 0.5 ml, a single subcutaneous (SC) injection via auto-injector (AI)

CT-P43BIOLOGICAL

CT-P43, 45 mg in 0.5 ml, a single subcutaneous (SC) injection via pre-filled syringe (PFS)

Eligibility

Sex: MALEMin age: 19 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Healthy male subjects, between the ages of 19 and 55 years, both inclusive. * Subject has a body weight between 60 to 90 kg, both inclusive, and a 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 hepatitis B virus, hepatitis C virus, human immunodeficiency virus, or syphilis * Active or latent Tuberculosis * History of malignancy * Previous exposure to ustekinumab or a biosimilar of ustekinumab or any drug that directly targets interleukin (IL)-12, IL-17 or IL-23

Locations (1)

Korea University Guro Hospital

Seoul, Guro-gu, South Korea

Outcomes

Primary Outcomes

PK similarity demonstration by AUC 0-inf

Demonstrate the PK similarity in terms of area under the concentration-time curve from time zero to infinity (AUC0-inf) of CT-P43 SC administration via AI versus PFS in healthy male subjects up to Day 113 (Week 16).

Time frame: Day113

PK similarity demonstration by Cmax

Demonstrate the PK similarity in terms of maximum serum concentration (Cmax) of CT-P43 SC administration via AI versus PFS in healthy male subjects up to Day 113 (Week 16).

Time frame: Day113

Secondary Outcomes

Additional PK evaluation

Evaluate additional PK in terms of AUC from time zero to the last quantifiable concentration (AUC0-last). Time to maximum concentration (Tmax), Terminal half-life (t1/2), Percentage of AUC0-inf obtained by extrapolation (%AUCextrap).

Time frame: Day113

Safety evaluation by AEs

Evaluate safety in terms of adverse events (including treatment-emergent adverse events \[TEAEs\] and serious adverse events\[SAEs\]).

Time frame: Day113

Data from ClinicalTrials.gov

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