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

Celltrion Healthcare

Status and phase: Active, not recruiting; Phase 1

Conditions: Healthy Male Subjects

Treatments: Biological: CT-P43

Study type: Interventional

Funder types: Industry

Identifiers

NCT06951828

CT-P43 1.3

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 162 patients

Sex: Male

Ages: 19 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

162 participants in 2 patient groups

CT-P43 Auto-injector

Experimental group

Description:

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

Treatment:

Biological: CT-P43

Biological: CT-P43

CT-P43 Pre-filled syringe

Active Comparator group

Description:

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

Treatment:

Biological: CT-P43

Biological: CT-P43