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

Phase 1

Recruiting

• Conditions: Healthy Subjects
• Interventions: Biological: CT-P47

• Registration Number: NCT05617183
• Lead Sponsor: Celltrion

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.

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 Timeline

• Study First Submitted: 2022-10-25
• Study First Submitted QC: 2022-11-13
• Study Start: 2022-11-15
• Study First Posted: 2022-11-15
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-24
• Last Update Posted: 2023-03-27
• Primary Completion: 2023-04
• Study Completion: 2023-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 268

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CT-P47 Auto-injector	CT-P47	CT-P47, 162 mg in 0.9 mL, a single subcutaneous (SC) injection via auto-injector (AI)
CT-P47 Pre-filled Syringe	CT-P47	CT-P47, 162 mg in 0.9 mL, a single subcutaneous (SC) injection via pre-filled syringe (PFS)

Primary Outcome Measures

Name	Time	Method
PK similarity demonstration by AUC	Day 43	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.
PK similarity demonstration by Cmax	Day 43	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of