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

NCT05617183 | Unknown Phase 1 FDA Drug

• 1 other identifier: CT-P47 1.3
• Study Type: interventional
• Target: 268
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy Subjects

Outcome Measures

Primary Outcomes (2)

• PK similarity demonstration by AUC

  Demonstrate PK similarity in terms of area under the concentration-time curve (AUC) from time zero to infinity (AUC0-inf) of CT-P47 SC administration via AI versus PFS in healthy subjects up to Day 43. The similarity of PK between CT-P47 AI vs CT-P47 PFS will be concluded if the 90% Cls for the ratios of geometric means of the comparison are entirely contained within the equivalence margin of 80% to 125% for AUC0-inf.

  Day 43

• PK similarity demonstration by Cmax

  Demonstrate PK similarity in terms of maximum serum concentration (Cmax) of CT-P47 SC administration via AI versus PFS in healthy subjects up to Day 43. The similarity of PK between CT-P47 AI vs CT-P47 PFS will be concluded if the 90% Cls for the ratios of geometric means of the comparison are entirely contained within the equivalence margin of 80% to 125% for Cmax.

  Day 43

Secondary Outcomes (2)

• Additional PK evaluation

  Day 43

• Safety evaluation by TEAEs

  Day 43

Study Arms (2)

CT-P47 Auto-injector

EXPERIMENTAL

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

Biological: CT-P47

CT-P47 Pre-filled Syringe

ACTIVE COMPARATOR

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

Biological: CT-P47

Interventions

CT-P47 BIOLOGICAL

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

CT-P47 Auto-injector

Eligibility Criteria

• Age: 19 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy male or female subjects between the ages of 19 to 55 years, both inclusive.
• 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.

You may not qualify if:

• 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 tocilizumab or any drug that targets IL-6

Sponsors & Collaborators

• Celltrion: lead

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

RECRUITING

Related Publications (1)

• Yu KS, Ryu H, Shin D, Park M, Hwang J, Moon SJ, Kim MG, Keystone E, Smolen JS, Kim S, Bae Y, Jeon D, Jang J, Yang G, Bae J, Lee J, Burmester GR. Pharmacokinetics and safety of candidate tocilizumab biosimilar CT-P47 administered by auto-injector or pre-filled syringe: a randomized, open-label, single-dose phase I study. Expert Opin Biol Ther. 2024 Jul;24(7):681-689. doi: 10.1080/14712598.2024.2321360. Epub 2024 Jun 21.

  PMID: 38905143 DERIVED

Study Officials

• KyungSang Yu

  Seoul National University College of Medicine and Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

MinAh Chun

CONTACT

+82 32 850 5761; minah.chun@celltrion.com

EnDa Ko

CONTACT

+82 32 850 5757; enda.ko@celltrion.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 25, 2022
• First Posted: November 15, 2022
• Study Start: November 15, 2022
• Primary Completion: April 1, 2023
• Study Completion: September 1, 2023
• Last Updated: March 27, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)