Healthy Male SubjectsPhase 1NCT07054970
To Compare the Pharmacokinetics, Safety and Immunogenicity of CT-P55 and Cosentyx in Healthy Subjects
A Phase 1 study testing CT-P55, US-licensed Cosentyx and EU-approved Cosentyx in people with Healthy Male Subjects, run by Celltrion at 4 sites in Japan.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Male Subjects
- What is being tested?
- CT-P55, US-licensed Cosentyx and EU-approved Cosentyx
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 172 participants
- Where
- 4 sitesJapan
- Study dates
- 12 Jan 2024to 6 Sep 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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)
Trial locations and contacts
4 sites in 1 country.
Japan4 sites
SOUSEIKAI Nishikumamoto Hospital
Kumamoto, Kumamoto
Kitasato University Kitasato Institute Hospital
Minato-ku, Tokyo, 108-8642
Medical Corporation Heishinkai OPHAC Hospital
Osaka, Osaka, 532-0003
Yokohama Minoru Clinic
Yokohama, Kanagawa, 232-0064
About this study
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
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
Read the detailed description
CT-P55, containing the active ingredient secukinumab, is being developed by CELLTRION, Inc. as a proposed biosimilar to the reference product, Cosentyx. In this study, Pharmacokinetics, Safety and Immunogenicity of CT-P55, EU-approved Cosentyx and US-licensed Cosentyx were evaluated in Healthy Male Subjects.
- Conditions
- Healthy Male Subjects
- Being tested
- CT-P55, US-licensed Cosentyx, EU-approved Cosentyx
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT-P55Biological
150 mg in 1.0 mL, administered as a single SC injection via PFS
US-licensed CosentyxBiological
150 mg in 1.0 mL, administered as a single SC injection via PFS
EU-approved CosentyxBiological
150 mg in 1.0 mL, administered as a single SC injection via PFS
| Study group | Role | What they receive |
|---|---|---|
| CT-P55 | Experimental | a single subcutaneous (SC) injection via pre-filled syringe (PFS) Receives: Biological: CT-P55 |
| US-licensed Cosentyx | Active comparator | a single SC injection via PFS Receives: Biological: US-licensed Cosentyx |
| EU-approved Cosentyx | Active comparator | a single SC injection via PFS Receives: Biological: EU-approved Cosentyx |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic (PK) similarity demonstration in terms of area under the concentration-time curve (AUC) from time zero to infinity (AUC0-inf)
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.
Measured: Day 155
PK similarity demonstration in terms of maximum serum concentration (Cmax)
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.
Measured: Day 155
Secondary outcomes (8)
Evaluate additional PK in terms of AUC from time zero to the last quantifiable concentration (AUC0-last)
Measured: Day 155
Evaluate additional PK in terms of Time to Cmax (Tmax)
Measured: Day155
Evaluate additional PK in terms of Apparent volume of distribution during the terminal phase after non-intravenous administration (Vz/F)
Measured: Day 155
Evaluate additional PK in terms of Terminal elimination rate constant (λz)
Measured: Day155
Evaluate additional PK in terms of Terminal elimination half-life (t1/2)
Measured: Day 155
Evaluate additional PK in terms of Apparent total body clearance (CL/F)
Measured: Day155
Evaluate additional PK in terms of Percentage of the area extrapolated for calculation of AUC0-inf (%AUCextrap)
Measured: 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.
Measured: Day 155
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2025
- Study start12 Jan 2024
- Primary completion29 Aug 2024
- Study completion6 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy Male SubjectsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 172 participants (actual)
Sponsor and investigators
- Lead sponsor
- Celltrion
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tomoko Hasunuma, Principal investigator, Kitasato University Kitasato Institute Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07054970
- Sponsor's protocol ID
- CT-P55 1.1
- Status last verified
- Jul 2025
- First submitted
- 22 Jun 2025
- Last updated
- 8 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hasunuma T, Yagi M, Nakamichi N, Blauvelt A, Thaci D, Suh J, Cha J, Noh I, Lee E, Papp KA. Pharmacokinetics and safety of candidate biosimilar CT-P55 versus reference secukinumab: a three-arm, randomized, double-blinded, single-dose, multicenter, Phase I study. Expert Opin Investig Drugs. 2026 Jan-Feb;35(2):179-188. doi: 10.1080/13543784.2026.2628208. Epub 2026 Feb 22.
PubMed 41665131
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07054970
- Acronym / sponsor ID
- CT-P55 1.1
- Conditions
- Healthy Male Subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 172 participants (actual)
- Lead sponsor
- CelltrionIndustry (pharma, biotech, devices)
- Study start
- 12 Jan 2024 (actual)
- Primary completion
- 29 Aug 2024 (actual)
- Study completion
- 6 Sep 2024 (actual)
- First posted
- 8 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
CT-P55, containing the active ingredient secukinumab, is being developed by CELLTRION, Inc. as a proposed biosimilar to the reference product, Cosentyx. In this study, Pharmacokinetics, Safety and Immunogenicity of CT-P55, EU-approved Cosentyx and US-licensed Cosentyx were evaluated in Healthy Male Subjects.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CT-P55 | Experimental | Biological: CT-P55a single subcutaneous (SC) injection via pre-filled syringe (PFS) |
| US-licensed Cosentyx | Active comparator | Biological: US-licensed Cosentyxa single SC injection via PFS |
| EU-approved Cosentyx | Active comparator | Biological: EU-approved Cosentyxa single SC injection via PFS |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CT-P55150 mg in 1.0 mL, administered as a single SC injection via PFS | Biological | CT-P55 |
| US-licensed Cosentyx150 mg in 1.0 mL, administered as a single SC injection via PFS | Biological | US-licensed Cosentyx |
| EU-approved Cosentyx150 mg in 1.0 mL, administered as a single SC injection via PFS | Biological | EU-approved Cosentyx |
Primary outcome
Pharmacokinetic (PK) similarity demonstration in terms of area under the concentration-time curve (AUC) from time zero to infinity (AUC0-inf)
Time frame: 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)
Time frame: 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.
8 secondary outcomes
Evaluate additional PK in terms of AUC from time zero to the last quantifiable concentration (AUC0-last)
Time frame: Day 155
Evaluate additional PK in terms of Time to Cmax (Tmax)
Time frame: Day155
Evaluate additional PK in terms of Apparent volume of distribution during the terminal phase after non-intravenous administration (Vz/F)
Time frame: Day 155
Evaluate additional PK in terms of Terminal elimination rate constant (λz)
Time frame: Day155
Evaluate additional PK in terms of Terminal elimination half-life (t1/2)
Time frame: Day 155
Evaluate additional PK in terms of Apparent total body clearance (CL/F)
Time frame: Day155
Evaluate additional PK in terms of Percentage of the area extrapolated for calculation of AUC0-inf (%AUCextrap)
Time frame: 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.
Time frame: Day 155
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2025.
- Derived from this study: PubMed 41665131Hasunuma T, Yagi M, Nakamichi N, Blauvelt A, Thaci D, Suh J, Cha J, Noh I, Lee E, Papp KA. Pharmacokinetics and safety of candidate biosimilar CT-P55 versus reference secukinumab: a three-arm, randomized, double-blinded, single-dose, multicenter, Phase I study. Expert Opin Investig Drugs. 2026 Jan-Feb;35(2):179-188. doi: 10.1080/13543784.2026.2628208. Epub 2026 Feb 22.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tomoko Hasunuma principal investigator
Kitasato University Kitasato Institute Hospital
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CT-P55, US-licensed Cosentyx and EU-approved Cosentyx in people with Healthy Male Subjects, run by Celltrion at 4 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacokinetic (PK) similarity demonstration in terms of area under the concentration-time curve (AUC) from time zero to infinity (AUC0-inf) (time frame: Day 155). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07054970, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2025; AzTrials last refreshed its copy on 8 Nov 2026.