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

Phase 1

Completed

Interventions: Biological: CT-P17
Biological: EU-approved Humira
Biological: US-licensed Humira

Brief 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

Recruitment & Eligibility

Inclusion Criteria

Healthy subjects
BMI between 18.0 and 29.9 kg/m2, both inclusive, when rounded to the nearest tenth

Exclusion Criteria

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)

Arm && Interventions

Group	Intervention	Description
CT-P17	CT-P17	a single subcutaneous (SC) injection via pre-filled syringe (PFS)
EU-approved Humira	EU-approved Humira	a single subcutaneous (SC) injection via pre-filled syringe (PFS)
US-licensed Humira	US-licensed Humira	a single subcutaneous (SC) injection via pre-filled syringe (PFS)

Primary Outcome Measures

Name	Time	Method
Area Under the Concentration-time Curve From Time Zero to Infinity (AUC0-inf)	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)	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)	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.

Secondary Outcome Measures

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

Locations (9): Chonbuk National University Hospital
🇰🇷
Jeonju, Jeollabuk-do, Korea, Republic of
Chungbuk National University Hospital
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Cheongju-si, Chungcheongbuk-do, Korea, Republic of
Severance Hospital
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Seoul, Korea, Republic of
Asan Medical Center
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Seoul, Korea, Republic of
Seoul National University Bundang Hospital
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Seongnam-si, Gyeonggi-do, Korea, Republic of
CHA Bundang Medical Center
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Seongnam-si, Gyeonggi-do, Korea, Republic of
Chungnam National University Hospital
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Daejeon, Korea, Republic of
Seoul National University Hospital
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Seoul, Korea, Republic of
Inje University Busan Paik Hospital
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Busan, Korea, Republic of