HealthyPhase 1NCT03970824

To Compare the Pharmacokinetics and Safety of CT-P17 and Humira in Healthy Subjects

A Phase 1 study testing CT-P17, US-licensed Humira and EU-approved Humira in people with Healthy, run by Celltrion at 9 sites in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This is a Phase 1, Randomized, Double-blind, Three-arm, Parallel group, Single-dose Study to Compare the Pharmacokinetics and Safety of CT-P17 and Humira (US licensed Humira and EU-approved Humira) 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
What is being tested?: CT-P17, US-licensed Humira and EU-approved Humira
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 312 participants
Where: 9 sitesSouth Korea
Study dates: 31 May 2019to 15 Jan 2020
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

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
BMI between 18.0 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 hepatitis B virus (except for past resolved infection), hepatitis C virus, human immunodeficiency virus, or syphilis
Active or latent Tuberculosis
History of malignancy
Previous monoclonal antibody or fusion protein treatment, or current use of any biologic
Planning to be pregnant or father a child or donate sperm within 5 month after administration
Undergone treatment with an investigational drug or participated in another clinical trial within 90 days or 5 half-lives (whichever is longer)

Trial locations and contacts

9 sites in 1 country.

City, postcode or hospital

9 sites in 1 country

South Korea9 sites

Inje University Busan Paik Hospital
Busan, 47392
Chungbuk National University Hospital
Cheongju-si, North Chungcheong, 28644
Chungnam National University Hospital
Daejeon, 35015
Chonbuk National University Hospital
Jeonju, Jeollabuk-do, 54907
CHA Bundang Medical Center
Seongnam-si, Gyeonggi-do, 13520
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 13620
Seoul National University Hospital
Seoul, 03080
Severance Hospital
Seoul, 03722
Asan Medical Center
Seoul, 05505

Other trials in South Korea

About this study

Official title: A Phase 1, Randomized, Double-blind, Three-arm, Parallel Group, Single-dose Study to Compare the Pharmacokinetics and Safety of CT-P17 and Humira (US-licensed Humira and EU-approved Humira) in Healthy Subjects

Conditions: Healthy
Being tested: CT-P17, US-licensed Humira, EU-approved Humira

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

CT-P17Biological
40 mg/0.4ml (100 mg/mL) administered as a single SC injection via PFS
US-licensed HumiraBiological
40 mg/0.4ml (100 mg/mL) administered as a single SC injection via PFS
EU-approved HumiraBiological
40 mg/0.4ml (100 mg/mL) administered as a single SC injection via PFS

Study groups in NCT03970824
Study group	Role	What they receive
CT-P17	Experimental	a single subcutaneous (SC) injection via pre-filled syringe (PFS) Receives: Biological: CT-P17
US-licensed Humira	Active comparator	a single subcutaneous (SC) injection via pre-filled syringe (PFS) Receives: Biological: US-licensed Humira
EU-approved Humira	Active comparator	a single subcutaneous (SC) injection via pre-filled syringe (PFS) Receives: Biological: EU-approved Humira

What is being measured

The primary outcome is the main question the study is designed to answer.

Area Under the Concentration-time Curve From Time Zero to Infinity (AUC0-inf)
Primary endpoints were equivalence of PK between CT-P17 and reference drugs in terms of AUC0-inf, AUC0-last, and Cmax. Blood samples for PK analysis were obtained pre-dose and at 6, 12, 24, 48, 72, 96, 108, 120, 132, 144, 168, 192, 336, 504, 672, 1008, 1344, and 1680 hour post-dose.
Measured: up to Day 71
Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUC0-last)
Primary endpoints were equivalence of PK between CT-P17 and reference drugs in terms of AUC0-inf, AUC0-last, and Cmax. Blood samples for PK analysis were obtained pre-dose and at 6, 12, 24, 48, 72, 96, 108, 120, 132, 144, 168, 192, 336, 504, 672, 1008, 1344, and 1680 hour post-dose.
Measured: up to Day 71
Maximum Serum Concentration (Cmax)
Primary endpoints were equivalence of PK between CT-P17 and reference drugs in terms of AUC0-inf, AUC0-last, and Cmax. Blood samples for PK analysis were obtained pre-dose and at 6, 12, 24, 48, 72, 96, 108, 120, 132, 144, 168, 192, 336, 504, 672, 1008, 1344, and 1680 hour post-dose.
Measured: up to Day 71

Secondary outcomes (2)

Time to the Maximum Serum Concentration (Tmax)
The secondary objective was to evaluate the additional PK parameters including Tmax and t1/2. Blood samples for PK analysis were obtained pre-dose and at 6, 12, 24, 48, 72, 96, 108, 120, 132, 144, 168, 192, 336, 504, 672, 1008, 1344, and 1680 hour post-dose.
Measured: up to Day 71
Terminal Elimination Half-life (t1/2)
The secondary objective was to evaluate the additional PK parameters including Tmax and t1/2. Blood samples for PK analysis were obtained pre-dose and at 6, 12, 24, 48, 72, 96, 108, 120, 132, 144, 168, 192, 336, 504, 672, 1008, 1344, and 1680 hour post-dose.
Measured: up to Day 71

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

31 May 201915 Jan 2020

First posted3 Jun 2019
Study start31 May 2019
Primary completion13 Nov 2019
Study completion15 Jan 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for HealthyStudies 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: 312 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03970824
Sponsor's protocol ID: CT-P17 1.1
Status last verified: Nov 2021
First submitted: 20 May 2019
Last updated: 18 Nov 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Yu KS, Jang IJ, Lim HS, Hong JH, Kim MG, Park MK, Cho DY, Park MS, Chung JY, Ghim JL, Lee S, Yoon SK, Kwon IS, Lee SJ, Kim SH, Bae YJ, Cha JB, Furst DE, Keystone E, Kay J. Pharmacokinetic equivalence of CT-P17 to high-concentration (100 mg/ml) reference adalimumab: A randomized phase I study in healthy subjects. Clin Transl Sci. 2021 Jul;14(4):1280-1291. doi: 10.1111/cts.12967. Epub 2021 Mar 2.
PubMed 33503313

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 18 Nov 2021. 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 and Safety of CT-P17 and Humira (US-licensed Humira and EU-approved Humira) in Healthy Subjects
ClinicalTrials.gov ID: NCT03970824
Acronym / sponsor ID: CT-P17 1.1
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 312 participants (actual)
Lead sponsor: CelltrionIndustry (pharma, biotech, devices)
Study start: 31 May 2019 (actual)
Primary completion: 13 Nov 2019 (actual)
Study completion: 15 Jan 2020 (actual)
First posted: 3 Jun 2019 (actual)
Results: Posted 11 Dec 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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-P17	Experimental	Biological: CT-P17a single subcutaneous (SC) injection via pre-filled syringe (PFS)
US-licensed Humira	Active comparator	Biological: US-licensed Humiraa single subcutaneous (SC) injection via pre-filled syringe (PFS)
EU-approved Humira	Active comparator	Biological: EU-approved Humiraa 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
BMI between 18.0 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 hepatitis B virus (except for past resolved infection), 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-P1740 mg/0.4ml (100 mg/mL) administered as a single SC injection via PFS	Biological	CT-P17
US-licensed Humira40 mg/0.4ml (100 mg/mL) administered as a single SC injection via PFS	Biological	US-licensed Humira
EU-approved Humira40 mg/0.4ml (100 mg/mL) administered as a single SC injection via PFS	Biological	EU-approved Humira

Primary outcome

Area Under the Concentration-time Curve From Time Zero to Infinity (AUC0-inf)
Time frame: up to Day 71
Primary endpoints were equivalence of PK between CT-P17 and reference drugs in terms of AUC0-inf, AUC0-last, and Cmax. Blood samples for PK analysis were obtained pre-dose and at 6, 12, 24, 48, 72, 96, 108, 120, 132, 144, 168, 192, 336, 504, 672, 1008, 1344, and 1680 hour post-dose.
Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUC0-last)
Time frame: up to Day 71
Primary endpoints were equivalence of PK between CT-P17 and reference drugs in terms of AUC0-inf, AUC0-last, and Cmax. Blood samples for PK analysis were obtained pre-dose and at 6, 12, 24, 48, 72, 96, 108, 120, 132, 144, 168, 192, 336, 504, 672, 1008, 1344, and 1680 hour post-dose.
Maximum Serum Concentration (Cmax)
Time frame: up to Day 71
Primary endpoints were equivalence of PK between CT-P17 and reference drugs in terms of AUC0-inf, AUC0-last, and Cmax. Blood samples for PK analysis were obtained pre-dose and at 6, 12, 24, 48, 72, 96, 108, 120, 132, 144, 168, 192, 336, 504, 672, 1008, 1344, and 1680 hour post-dose.

2 secondary outcomes

Time to the Maximum Serum Concentration (Tmax)
Time frame: up to Day 71
Terminal Elimination Half-life (t1/2)
Time frame: up to Day 71

Results and safety

Results posted to the registry on 11 Dec 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
CT-P17	103	101
US-licensed Humira	103	100
EU-approved Humira	106	102

Primary outcome: Area Under the Concentration-time Curve From Time Zero to Infinity (AUC0-inf)

Time frame: up to Day 71. Mean (Standard Deviation). Unit: h•μg/mL

Measure	CT-P17 n = 80	US-licensed Humira n = 86	EU-approved Humira n = 89
Value	2656.5 (1150.16)	2469.7 (917.47)	2690.6 (943.76)

CT-P17 vs US-licensed Humira: Ratio of geometric least squares means: 105.79 (90% CI 97.19 to 115.16)
US-licensed Humira vs EU-approved Humira: Ratio of geometric least squares means: 92.63 (90% CI 85.29 to 100.61)
CT-P17 vs EU-approved Humira: Ratio of geometric least squares means: 98.00 (90% CI 90.06 to 106.63)

Population analysed: Pharmacokinetic population (all randomly assigned subjects who received a complete dose of study drug and provided at least 1 post-treatment serum concentration above the lower limit of quantification for adalimumab)

Primary outcome: Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUC0-last)

Time frame: up to Day 71. Mean (Standard Deviation). Unit: h•μg/mL

Measure	CT-P17 n = 96	US-licensed Humira n = 93	EU-approved Humira n = 98
Value	2372.7 (954.82)	2185.0 (795.91)	2394.7 (866.95)

CT-P17 vs US-licensed Humira: Ratio of geometric least squares means: 107.30 (90% CI 98.29 to 117.13)
US-licensed Humira vs EU-approved Humira: Ratio of geometric least squares means: 93.93 (90% CI 86.08 to 102.50)
CT-P17 vs EU-approved Humira: Ratio of geometric least squares means: 100.79 (90% CI 92.42 to 109.92)

Primary outcome: Maximum Serum Concentration (Cmax)

Time frame: up to Day 71. Mean (Standard Deviation). Unit: μg/mL

Measure	CT-P17 n = 96	US-licensed Humira n = 93	EU-approved Humira n = 98
Value	3.619 (1.3522)	3.556 (1.1972)	3.660 (1.2212)

CT-P17 vs US-licensed Humira: Ratio of geometric least squares means: 101.89 (90% CI 95.33 to 108.89)
US-licensed Humira vs EU-approved Humira: Ratio of geometric least squares means: 98.20 (90% CI 91.91 to 104.92)
CT-P17 vs EU-approved Humira: Ratio of geometric least squares means: 100.05 (90% CI 93.69 to 106.85)

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were assessed from the time the ICF was signed and until the end of the subject's participation in the study (up to Day 71).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
CT-P17	2 of 102 (2%)	26 of 102 (25.5%)	0 of 102
US-licensed Humira	0 of 102 (0%)	27 of 102 (26.5%)	0 of 102
EU-approved Humira	1 of 104 (1%)	27 of 104 (26%)	0 of 104

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 33503313Yu KS, Jang IJ, Lim HS, Hong JH, Kim MG, Park MK, Cho DY, Park MS, Chung JY, Ghim JL, Lee S, Yoon SK, Kwon IS, Lee SJ, Kim SH, Bae YJ, Cha JB, Furst DE, Keystone E, Kay J. Pharmacokinetic equivalence of CT-P17 to high-concentration (100 mg/ml) reference adalimumab: A randomized phase I study in healthy subjects. Clin Transl Sci. 2021 Jul;14(4):1280-1291. doi: 10.1111/cts.12967. Epub 2021 Mar 2.
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.

Sang Joon Lee study director

Celltrion, Inc.

9 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-P17, US-licensed Humira and EU-approved Humira in people with Healthy, run by Celltrion at 9 sites 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 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 18 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites 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?

Yes. Results are posted in the registry (first posted 11 Dec 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Area Under the Concentration-time Curve From Time Zero to Infinity (AUC0-inf) (time frame: up to Day 71). 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 NCT03970824, 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 18 Nov 2021.