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

Healthy Subjects Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05617183
• Other study ID #: CT-P47 1.3
• Status: Recruiting
• Phase: Phase 1
• Start date: November 15, 2022
• Est. completion date: September 2023

Study information

• Verified date: March 2023
• Source: Celltrion
• Contact: MinAh Chun
• Phone: +82 32 850 5761
• Email: minah.chun[@]celltrion.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 268
• Est. completion date: September 2023
• Est. primary completion date: April 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Subjects

Intervention

Biological:
• CT-P47
CT-P47, 162 mg in 0.9 mL, a single subcutaneous (SC) injection via auto-injector (AI)
• CT-P47
CT-P47, 162 mg in 0.9 mL, a single subcutaneous (SC) injection via pre-filled syringe (PFS)

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Celltrion

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

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