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

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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)

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
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

Trial contacts and locations

1

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Central trial contact

MinAh Chun; EnDa Ko

Data sourced from clinicaltrials.gov

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