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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE1

Total Enrollment

162 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-30

Study Completion Date

2026-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Compare the Auto-injector and Pre-filled Syringe of CT-P47 in Healthy Subjects

NCT05617183

Healthy Subjects

UNKNOWN PHASE1

A Study of Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of CC-90006 in Healthy Subjects

NCT02934269

Healthy Volunteers

COMPLETED PHASE1

Assessment of Pharmacokinetics and Safety of M923 Administered Via Auto-injector or Prefilled Syringe, in Healthy Subjects

NCT02675023

Healthy

COMPLETED PHASE1

Pharmacokinetics, Safety, and Tolerability Study of the Autoinjector and Pre-filled Syringe of SB4 in Healthy Male Subjects

NCT03193203

Healthy

COMPLETED PHASE1

Safety and Pharmacokinetic Characteristics of HD203 in Healthy Male Volunteers

NCT01044836

Healthy

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy Male Subjects

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

CT-P43 Auto-injector

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

Group Type EXPERIMENTAL

CT-P43

Intervention Type BIOLOGICAL

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

CT-P43 Pre-filled syringe

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

Group Type ACTIVE_COMPARATOR

CT-P43

Intervention Type BIOLOGICAL

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

CT-P43

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

Intervention Type BIOLOGICAL

CT-P43

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

Intervention Type BIOLOGICAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

19 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes