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

Celltrion Healthcare

Status and phase: Enrolling; Phase 1

Conditions: Healthy Subjects

Treatments: Biological: CT-P47

Study type: Interventional

Funder types: Industry

Identifiers

NCT05617183

CT-P47 1.3

Details and patient eligibility

About

This is a phase 1 study to compare the Pharmacokinetics and Safety of the Auto-injector and Pre-filled syringe of CT-P47 in Healthy Subjects.

Full description

CT-P47, containing the active ingredient tocilizumab, is a recombinant humanized monoclonal antibody that is being developed as a similar biological medicinal product to RoActemra/Actemra. The purpose of this study is to demonstrate the pharmacokinetics and safety of the Auto-injector and Pre-filled syringe of CT-P47 in healthy subjects.

Enrollment: 268 estimated patients

Sex: All

Ages: 19 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Healthy male or female subjects between the ages of 19 to 55 years, both inclusive.
2. Subject with a body weight of ≥60 and ≤100 kg for male and ≥50 and ≤100 kg for female and a BMI between 18.5 and 28.0 kg/m2 (both inclusive) when rounded to the nearest tenth.

Exclusion criteria

1. A medical history and/or condition that is considered significant
2. Clinically significant allergic reactions, hypersensitivity
3. History or current infection of hepatitis B virus, hepatitis C virus, human immunodeficiency virus, or syphilis
4. Active or latent Tuberculosis
5. History of malignancy
6. Previous exposure to tocilizumab or any drug that targets IL-6

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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268 participants in 2 patient groups

CT-P47 Auto-injector

Experimental group

Description:

CT-P47, 162 mg in 0.9 mL, a single subcutaneous (SC) injection via auto-injector (AI)

Treatment:

Biological: CT-P47

Biological: CT-P47

CT-P47 Pre-filled Syringe

Active Comparator group

Description:

CT-P47, 162 mg in 0.9 mL, a single subcutaneous (SC) injection via pre-filled syringe (PFS)

Treatment:

Biological: CT-P47

Biological: CT-P47