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

A Phase 1, Randomized, Open-label, Two-arm, Parallel Group, Single-dose Study to Compare the Pharmacokinetics and Safety of the Auto-injector and Pre-filled Syringe of CT-P47 in Healthy Subjects

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.

Study Overview

• Status: Recruiting
• Conditions: Healthy Subjects
• Intervention / Treatment: Biological: CT-P47; Biological: CT-P47

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 268
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: MinAh Chun; Phone Number: +82 32 850 5761; Email: minah.chun@celltrion.com
• Study Contact Backup: Name: EnDa Ko; Phone Number: +82 32 850 5757; Email: enda.ko@celltrion.com

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Recruiting
    • Seoul National University Hospital
    • Contact: KyungSang Yu; Phone Number: 81-2-2072-1666

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CT-P47 Auto-injector; CT-P47, 162 mg in 0.9 mL, a single subcutaneous (SC) injection via auto-injector (AI)	Biological: CT-P47; CT-P47, 162 mg in 0.9 mL, a single subcutaneous (SC) injection via auto-injector (AI); Biological: CT-P47; CT-P47, 162 mg in 0.9 mL, a single subcutaneous (SC) injection via pre-filled syringe (PFS)
Active Comparator: CT-P47 Pre-filled Syringe; CT-P47, 162 mg in 0.9 mL, a single subcutaneous (SC) injection via pre-filled syringe (PFS)	Biological: CT-P47; CT-P47, 162 mg in 0.9 mL, a single subcutaneous (SC) injection via auto-injector (AI); Biological: CT-P47; CT-P47, 162 mg in 0.9 mL, a single subcutaneous (SC) injection via pre-filled syringe (PFS)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Additional PK evaluation	Evaluate additional PK in terms of AUC from time zero to the last quantifiable concentration (AUC0-last).	Day 43
Safety evaluation by TEAEs	Evaluate safety in terms of treatment-emergent adverse events (TEAEs) of CT-P47.	Day 43

Collaborators and Investigators

• Sponsor: Celltrion
• Investigators: Principal Investigator: KyungSang Yu, Seoul National University College of Medicine and Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 15, 2022
• Primary Completion (Anticipated): April 1, 2023
• Study Completion (Anticipated): September 1, 2023

Study Registration Dates

• First Submitted: October 25, 2022
• First Submitted That Met QC Criteria: November 13, 2022
• First Posted (Actual): November 15, 2022

Study Record Updates

• Last Update Posted (Actual): March 27, 2023
• Last Update Submitted That Met QC Criteria: March 24, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: CT-P47 1.3

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No