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

Study Overview
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Brief Summary
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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

Official Title
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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
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Healthy

Intervention / Treatment
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* Biological: CT-P17
* Biological: US-licensed Humira
* Biological: EU-approved Humira


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CT-P17<br>a single subcutaneous (SC) injection via pre-filled syringe (PFS) | Biological: CT-P17<br>* 40 mg/0.4ml (100 mg/mL) administered as a single SC injection via PFS<br>|
| Active Comparator: US-licensed Humira<br>a single subcutaneous (SC) injection via pre-filled syringe (PFS) | Biological: US-licensed Humira<br>* 40 mg/0.4ml (100 mg/mL) administered as a single SC injection via PFS<br>|
| Active Comparator: EU-approved Humira<br>a single subcutaneous (SC) injection via pre-filled syringe (PFS) | Biological: EU-approved Humira<br>* 40 mg/0.4ml (100 mg/mL) administered as a single SC injection via PFS<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | up to Day 71 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | up to Day 71 |