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
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Healthy
- Sponsor
- Celltrion
- Enrollment
- 312
- Locations
- 9
- Primary Endpoint
- Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUC0-last)
- Status
- Completed
- Last Updated
- 4 years ago
Overview
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
Investigators
Eligibility Criteria
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)
Outcomes
Primary Outcomes
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.
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.
Secondary Outcomes
- Terminal Elimination Half-life (t1/2)(up to Day 71)
- Time to the Maximum Serum Concentration (Tmax)(up to Day 71)