Healthy SubjectsPhase 1NCT04428814
Study to Compare PK and Safety of Subcutaneous Injection of Ustekinumab and CT-P43 in Healthy Subjects
A Phase 1 study testing CT-P43, EU-approved Stelara and US-licensed Stelara in people with Healthy Subjects, run by Celltrion at 2 sites in New Zealand.
Trial summary
This study is a Phase 1, 2-Part, Randomized, Double-Blind, Parallel-Group, Single-Dose Study to Compare the Pharmacokinetics, Safety and Immunogenicity of Three Subcutaneous Injection Formulations of Ustekinumab (CT-P43, EU approved Stelara, and US licensed Stelara) 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 Subjects
- What is being tested?
- CT-P43, EU-approved Stelara and US-licensed Stelara
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 271 participants
- Where
- 2 sitesNew Zealand
- Study dates
- 3 Aug 2020to 24 Feb 2021
- 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.
- Subject with a BMI between 18.5 and 29.9 kg/m2. Weight between 60 to 100 kg.
- Subject must agree to use medically acceptable methods of contraception consistent with local regulations during the course of the study and for 18 weeks after administration of the study drug.
- Subject is informed and able to understand the full nature and purpose of the study, including possible risks and side effects, and is given ample time and opportunity to read and understand this information.
Who cannot join
- Subject has a prohibited medical history and/or current condition.
- Subject is planning to father a child or donate sperm within 18 weeks after the administration of the study drug (Day 1).
- Subject previously received any biologic agents
- In the opinion of the investigator, the subject is not eligible for the study participation for any reason.
- Subject is vulnerable.
Trial locations and contacts
2 sites in 1 country.
New Zealand2 sites
Christchurch Clinical Studies Trust Limited
Christchurch, Canterbury, 8011
Auckland Clinical Studies Limited
Grafton, Auckland, 1010
About this study
Official title: A Phase 1, 2-Part, Randomized, Double-Blind, Parallel-Group, Single-Dose Study to Compare the Pharmacokinetics, Safety and Immunogenicity of Three Subcutaneous Injection Formulations of Ustekinumab in Healthy Male Subjects
This study is a Phase 1, 2-Part, Randomized, Double-Blind, Parallel-Group, Single-Dose Study to Compare the Pharmacokinetics, Safety and Immunogenicity of Three Subcutaneous Injection Formulations of Ustekinumab (CT-P43, EU approved Stelara, and US licensed Stelara) in Healthy Male Subjects.
Read the detailed description
CT-P43 is being developed as a proposed biosimilar of Stelara (ustekinumab). This study will be conducted in 2 parts. In Part 1, subjects will be enrolled and randomized in a 1:1 ratio to receive a single dose (45 mg) of either CT-P43 or EU-approved Stelara to collect preliminary safety data for CT-P43. In Part 2, subjects will be enrolled and randomized in a 1:1:1 ratio to receive a single dose (45 mg) of CT-P43, EU-approved Stelara, or US-licensed Stelara to demonstrate PK similarity. Each part will proceed independently, and subjects will be randomized to either Part 1 or Part 2 of the study subsequently. All subjects in Part 1 and Part 2 will undergo the same assessments. In each treatment arm in Part 1 and Part 2, all subjects will receive a study drug subcutaneously via PFS. The randomization to treatment assignment will be stratified by study center and body weight as measured at baseline to balance subject weight across treatment groups. Subjects will be confined to the study center until all required 24-hour post-dose assessments have been completed and will be discharged on Day 2. Subsequent visits will be carried out on an out-patient basis up to EOS.
- Conditions
- Healthy Subjects
- Being tested
- CT-P43, EU-approved Stelara, US-licensed Stelara
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT-P43Biological
45mg single dose
EU-approved StelaraBiological
45mg single dose
US-licensed StelaraBiological
45mg single dose
| Study group | Role | What they receive |
|---|---|---|
| CT-P43 (Part 1) | Experimental | 45mg single dose administration Receives: Biological: CT-P43 |
| EU-approved Stelara (Part 1) | Active comparator | 45mg single dose administration Receives: Biological: EU-approved Stelara |
| CT-P43 (Part 2) | Experimental | 45mg single dose administration Receives: Biological: CT-P43 |
| EU-approved Stelara (Part 2) | Active comparator | 45mg single dose administration Receives: Biological: EU-approved Stelara |
| US-licensed Stelara (Part 2) | Active comparator | 45mg single dose administration Receives: Biological: US-licensed Stelara |
What is being measured
The primary outcome is the main question the study is designed to answer.
Demonstrate PK similarity
under the concentration-time curve from time zero to infinity (AUC0-inf) of CT-P43, EU-approved Stelara, and US-licensed Stelara
Measured: through study completion, up to day 127
Demonstrate PK similarity
maximum serum concentration (Cmax) of CT-P43, EU-approved Stelara, and US-licensed Stelara
Measured: through study completion, up to day 127
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2020
- Study start3 Aug 2020
- Primary completion24 Feb 2021
- Study completion24 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 271 participants (actual)
Sponsor and investigators
- Lead sponsor
- Celltrion
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04428814
- Sponsor's protocol ID
- CT-P43 1.1
- Status last verified
- Aug 2021
- First submitted
- 8 Jun 2020
- Last updated
- 5 Aug 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, 2-Part, Randomized, Double-Blind, Parallel-Group, Single-Dose Study to Compare the Pharmacokinetics, Safety and Immunogenicity of Three Subcutaneous Injection Formulations of Ustekinumab in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT04428814
- Acronym / sponsor ID
- CT-P43 1.1
- Conditions
- Healthy Subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 271 participants (actual)
- Lead sponsor
- CelltrionIndustry (pharma, biotech, devices)
- Study start
- 3 Aug 2020 (actual)
- Primary completion
- 24 Feb 2021 (actual)
- Study completion
- 24 Feb 2021 (actual)
- First posted
- 11 Jun 2020 (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 study is a Phase 1, 2-Part, Randomized, Double-Blind, Parallel-Group, Single-Dose Study to Compare the Pharmacokinetics, Safety and Immunogenicity of Three Subcutaneous Injection Formulations of Ustekinumab (CT-P43, EU approved Stelara, and US licensed Stelara) in Healthy Male Subjects.
Detailed description
CT-P43 is being developed as a proposed biosimilar of Stelara (ustekinumab). This study will be conducted in 2 parts. In Part 1, subjects will be enrolled and randomized in a 1:1 ratio to receive a single dose (45 mg) of either CT-P43 or EU-approved Stelara to collect preliminary safety data for CT-P43. In Part 2, subjects will be enrolled and randomized in a 1:1:1 ratio to receive a single dose (45 mg) of CT-P43, EU-approved Stelara, or US-licensed Stelara to demonstrate PK similarity. Each part will proceed independently, and subjects will be randomized to either Part 1 or Part 2 of the study subsequently. All subjects in Part 1 and Part 2 will undergo the same assessments. In each treatment arm in Part 1 and Part 2, all subjects will receive a study drug subcutaneously via PFS. The randomization to treatment assignment will be stratified by study center and body weight as measured at baseline to balance subject weight across treatment groups. Subjects will be confined to the study center until all required 24-hour post-dose assessments have been completed and will be discharged on Day 2. Subsequent visits will be carried out on an out-patient basis up to EOS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| CT-P43 (Part 1) | Experimental | Biological: CT-P4345mg single dose administration |
| EU-approved Stelara (Part 1) | Active comparator | Biological: EU-approved Stelara45mg single dose administration |
| CT-P43 (Part 2) | Experimental | Biological: CT-P4345mg single dose administration |
| EU-approved Stelara (Part 2) | Active comparator | Biological: EU-approved Stelara45mg single dose administration |
| US-licensed Stelara (Part 2) | Active comparator | Biological: US-licensed Stelara45mg single dose administration |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy male subjects, between the ages of 18 and 55 years.
- Subject with a BMI between 18.5 and 29.9 kg/m2. Weight between 60 to 100 kg.
- Subject must agree to use medically acceptable methods of contraception consistent with local regulations during the course of the study and for 18 weeks after administration of the study drug.
- Subject is informed and able to understand the full nature and purpose of the study, including possible risks and side effects, and is given ample time and opportunity to read and understand this information.
Key exclusion criteria (5 listed)
- Subject has a prohibited medical history and/or current condition.
- Subject is planning to father a child or donate sperm within 18 weeks after the administration of the study drug (Day 1).
- Subject previously received any biologic agents
- In the opinion of the investigator, the subject is not eligible for the study participation for any reason.
- Subject is vulnerable.
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-P4345mg single dose | Biological | CT-P43 (Part 1), CT-P43 (Part 2) |
| EU-approved Stelara45mg single dose | Biological | EU-approved Stelara (Part 1), EU-approved Stelara (Part 2) |
| US-licensed Stelara45mg single dose | Biological | US-licensed Stelara (Part 2) |
Primary outcome
Demonstrate PK similarity
Time frame: through study completion, up to day 127
under the concentration-time curve from time zero to infinity (AUC0-inf) of CT-P43, EU-approved Stelara, and US-licensed Stelara
Demonstrate PK similarity
Time frame: through study completion, up to day 127
maximum serum concentration (Cmax) of CT-P43, EU-approved Stelara, and US-licensed Stelara
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 5 Aug 2021.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 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-P43, EU-approved Stelara and US-licensed Stelara in people with Healthy Subjects, run by Celltrion at 2 sites in New Zealand.
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 4 inclusion and 5 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 5 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in New Zealand. 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?
Demonstrate PK similarity (time frame: through study completion, up to day 127). 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?
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 5 Aug 2021.