Healthy SubjectsPhase 1NCT05188378
A Study to Compare the Pharmacokinetics and Safety of CT-P47 and RoActemra in Healthy Subjects
A Phase 1 study testing CT-P47 and EU-approved RoActemra, in people with Healthy Subjects, run by Celltrion at 1 site in South Korea.
Trial summary
A study to Compare the Pharmacokinetics and Safety of CT-P47 and RoActemra in Healthy Subjects Read more about this study
- Who is it for?
- Ages 19 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- What is being tested?
- CT-P47 and EU-approved RoActemra,
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteSouth Korea
- Study dates
- 22 Dec 2021to 31 Jan 2023
- 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 19 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy subjects
- 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
Who cannot join
- A medical history and/or condition that is considered significant
- Clinically significant allergic reactions, hypersensitivity
- History or current infection of hepatitis B virus, hepatitis C virus, human immunodeficiency virus, or syphilis
- Active or latent Tuberculosis
- History of malignancy
- Previous exposure to tocilizumab or any drug that targets IL-6
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Hospital
Seoul, 03080
Kyungsang Yu, 02-741-4221
Kyungsang Yu
About this study
Official title: A Phase 1, Randomized, Double-blind, Two-arm, Parallel Group, Single-dose Study to Compare the Pharmacokinetics and Safety of Two Subcutaneous Injection Formulations of Tocilizumab (CT-P47 and EU-approved RoActemra) in Healthy Subjects
A study to Compare the Pharmacokinetics and Safety of CT-P47 and RoActemra in Healthy Subjects
Read the detailed description
Subjects will be randomized in a 1:1 ratio to receive a single dose (162 mg) of either CT-P47 or EU-approved RoActemra.
- Conditions
- Healthy Subjects
- Being tested
- CT-P47, EU-approved RoActemra,
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT-P47Biological
162 mg in 0.9 mL, a single subcutaneous (SC) injection via pre-filled syringe (PFS)
EU-approved RoActemra,Biological
162 mg in 0.9 mL, a single subcutaneous (SC) injection via pre-filled syringe (PFS)
| Study group | Role | What they receive |
|---|---|---|
| CT-P47 | Experimental | 162 mg in 0.9 mL, a single subcutaneous (SC) injection via pre-filled syringe (PFS) Receives: Biological: CT-P47 |
| EU-approved RoActemra | Active comparator | 162 mg in 0.9 mL, a single subcutaneous (SC) injection via pre-filled syringe (PFS) Receives: Biological: EU-approved RoActemra, |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary objective
To demonstrate PK similarity in terms of Area under the zero to infinity (AUC0-inf)
Measured: up to Day 43
Primary objective
To demonstrate PK similarity in terms of Area under the concentration-time curve from time zero to the last quantifiable concentration (AUC0-last)
Measured: up to Day 43
Primary objective
To demonstrate PK similarity in terms of Maximum serum concentration (Cmax)
Measured: up to Day 43
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2022
- Study start22 Dec 2021
- Primary completion1 Oct 2022 (estimated)
- Study completion31 Jan 2023 (estimated)
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 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
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Celltrion
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- KyungSang Yu, Principal investigator, Seoul National University HospitalJaeYong Chung, Principal investigator, Seoul National University Bundang HospitalHyeWon Chung, Principal investigator, Korea University Guro HospitalDongSeong Shin, Principal investigator, Gachon University Gil Medical CenterMinKyu Park, Principal investigator, Chungbuk National University HospitalMinGul Kim, Principal investigator, Jeonbuk National University HospitalJongLyul Ghim, Principal investigator, Inje University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05188378
- Sponsor's protocol ID
- CT-P47 1.1
- Status last verified
- Dec 2021
- First submitted
- 10 Dec 2021
- Last updated
- 12 Jan 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Yu KS, Kim B, Shin D, Park MK, Hwang JG, Kim MG, Chung H, Ghim J, Chung JY, Smolen JS, Burmester GR, Kim S, Bae Y, Jeon D, Yoo J, Yang G, Bae J, Keystone E. Pharmacokinetics and safety of candidate tocilizumab biosimilar CT-P47 versus reference tocilizumab: a randomized, double-blind, single-dose phase I study. Expert Opin Investig Drugs. 2023 May;32(5):429-439. doi: 10.1080/13543784.2023.2212155. Epub 2023 May 26.
PubMed 37231670
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Double-blind, Two-arm, Parallel Group, Single-dose Study to Compare the Pharmacokinetics and Safety of Two Subcutaneous Injection Formulations of Tocilizumab (CT-P47 and EU-approved RoActemra) in Healthy Subjects
- ClinicalTrials.gov ID
- NCT05188378
- Acronym / sponsor ID
- CT-P47 1.1
- Conditions
- Healthy Subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- CelltrionIndustry (pharma, biotech, devices)
- Study start
- 22 Dec 2021 (actual)
- Primary completion
- 1 Oct 2022 (estimated)
- Study completion
- 31 Jan 2023 (estimated)
- First posted
- 12 Jan 2022 (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.
A study to Compare the Pharmacokinetics and Safety of CT-P47 and RoActemra in Healthy Subjects
Detailed description
Subjects will be randomized in a 1:1 ratio to receive a single dose (162 mg) of either CT-P47 or EU-approved RoActemra.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CT-P47 | Experimental | Biological: CT-P47162 mg in 0.9 mL, a single subcutaneous (SC) injection via pre-filled syringe (PFS) |
| EU-approved RoActemra | Active comparator | Biological: EU-approved RoActemra,162 mg in 0.9 mL, a single subcutaneous (SC) injection via pre-filled syringe (PFS) |
Who may qualify
- Ages
- 19 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy subjects
- 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
Key exclusion criteria (6 listed)
- A medical history and/or condition that is considered significant
- Clinically significant allergic reactions, hypersensitivity
- History or current infection of hepatitis B virus, hepatitis C virus, human immunodeficiency 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-P47162 mg in 0.9 mL, a single subcutaneous (SC) injection via pre-filled syringe (PFS) | Biological | CT-P47 |
| EU-approved RoActemra,162 mg in 0.9 mL, a single subcutaneous (SC) injection via pre-filled syringe (PFS) | Biological | EU-approved RoActemra |
Primary outcome
Primary objective
Time frame: up to Day 43
To demonstrate PK similarity in terms of Area under the zero to infinity (AUC0-inf)
Primary objective
Time frame: up to Day 43
To demonstrate PK similarity in terms of Area under the concentration-time curve from time zero to the last quantifiable concentration (AUC0-last)
Primary objective
Time frame: up to Day 43
To demonstrate PK similarity in terms of Maximum serum concentration (Cmax)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2022.
- Derived from this study: PubMed 37231670Yu KS, Kim B, Shin D, Park MK, Hwang JG, Kim MG, Chung H, Ghim J, Chung JY, Smolen JS, Burmester GR, Kim S, Bae Y, Jeon D, Yoo J, Yang G, Bae J, Keystone E. Pharmacokinetics and safety of candidate tocilizumab biosimilar CT-P47 versus reference tocilizumab: a randomized, double-blind, single-dose phase I study. Expert Opin Investig Drugs. 2023 May;32(5):429-439. doi: 10.1080/13543784.2023.2212155. Epub 2023 May 26.
- 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.
KyungSang Yu principal investigator
Seoul National University Hospital
JaeYong Chung principal investigator
Seoul National University Bundang Hospital
HyeWon Chung principal investigator
Korea University Guro Hospital
1 site 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-P47 and EU-approved RoActemra, in people with Healthy Subjects, run by Celltrion at 1 site in South Korea.
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 6 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: status not confirmed, as of the sponsor's last update on 12 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact YeonJu Kim (82-32-850-5774, yeonju.kim2@celltrion.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary objective (time frame: up to Day 43). The study lists 3 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 NCT05188378, 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 12 Jan 2022.