To Compare the Pharmacokinetics, Safety and Immunogenicity of CT-P55 and Cosentyx in Healthy Subjects
- Summary
- This is a Phase 1, Randomized, Double-blind, three-arm, Parallel group, Single-dose Study to Compare the Pharmacokinetics, Safety and immunogenicity of CT-P55, EU-approved Cosentyx and US-licensed Cosentyx in Healthy male Subjects
- Short title
- To Compare the Pharmacokinetics, Safety and Immunogenicity of CT-P55 and Cosentyx in Healthy Subjects
- Official title
- A Phase 1, Randomized, Double-blind, Three-arm, Parallel Group, Single-dose Study to Compare the Pharmacokinetics, Safety and Immunogenicity of CT-P55, EU-approved Cosentyx and US-licensed Cosentyx in Healthy Male Subjects
- Control arm
- Active comparator
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Completion date
- 2024-09-06
- First posted
- 2025-07-08
- Registry last updated
- 2025-07-08
- Primary completion date
- 2024-08-29
- Start date
- 2024-01-12
- Actual participants
- Participants
- Participant count basis
- Actual
- Protocol amendments
- Number of sites
- Data monitoring committee
- Registry sponsor category
- Industry
- Lead sponsor
- Celltrion
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT07054970
- ClinicalTrials.gov ID
- NCT07054970
- Registry record
- Open registry record
- Allocation
- Randomised
- Model
- Parallel groups
- Purpose
- Other
- Masking
- Quadruple masking
- Masked roles
- Participants, Care providers, Investigators, Outcome assessors
Pharmacokinetic (PK) similarity demonstration in terms of area under the concentration-time curve (AUC) from time zero to infinity (AUC0-inf)
Timeframe: Day 155
Demonstrate PK similarity in terms of area under the concentration-time curve (AUC) from time zero to infinity (AUC0-inf) of CT-P55, European Union (EU)-approved Cosentyx and United States (US)-licensed Cosentyx in healthy male subjects. The similarity of PK 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 in terms of maximum serum concentration (Cmax)
Timeframe: Day 155
Demonstrate PK similarity in terms of Cmax of CT-P55, EU-approved Cosentyx and US-licensed Cosentyx in healthy male subjects up to Day 155. The similarity of PK 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.
Evaluate additional PK in terms of AUC from time zero to the last quantifiable concentration (AUC0-last)
Timeframe: Day 155
Evaluate additional PK in terms of Time to Cmax (Tmax)
Timeframe: Day155
Evaluate additional PK in terms of Apparent volume of distribution during the terminal phase after non-intravenous administration (Vz/F)
Timeframe: Day 155
Evaluate additional PK in terms of Terminal elimination rate constant (λz)
Timeframe: Day155
Evaluate additional PK in terms of Terminal elimination half-life (t1/2)
Timeframe: Day 155
Evaluate additional PK in terms of Apparent total body clearance (CL/F)
Timeframe: Day155
Evaluate additional PK in terms of Percentage of the area extrapolated for calculation of AUC0-inf (%AUCextrap)
Timeframe: Day 155
Evaluate safety in terms of treatment-emergent adverse events (TEAEs) of CT-P55 as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Timeframe: Day 155
- Sex
- Male
- Age groups
- Adults
- Minimum age
- 18 Years
- Maximum age
- 55 Years
- Healthy volunteers
- Yes
- Healthy male subjects between the ages of 18 and 55 years, both inclusive.
- Body weight between 50.0 kg and 90.0 kg (both inclusive), and Body Mass Index (BMI) between 18.5 and 29.9 kg/m2 (both inclusive), when rounded to the nearest tenth.
- A medical history and/or condition that is considered significant
- Clinically significant allergic reactions, hypersensitivity
- History or current infection of human immunodeficiency virus, hepatitis B virus, hepatitis C virus or syphilis
- Active or latent Tuberculosis
- History of malignancy
- Previous monoclonal antibody or fusion protein treatment, or current use of any biologics
- Planning to be father a child or donate sperm within 22 weeks period following study drug administration.
- Undergone treatment with an investigational drug or participated in another clinical trial within 12weeks or 5 half-lives (whichever is longer)
- Yokohama Minoru ClinicYokohama, Japan
- SOUSEIKAI Nishikumamoto HospitalKumamoto, Japan
- Medical Corporation Heishinkai OPHAC HospitalOsaka, Japan
- Kitasato University Kitasato Institute HospitalMinato-ku, Japan
- PubMed 41665131Related publication