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

Celltrion Healthcare

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Biological: EU-approved Humira; Biological: CT-P17; Biological: US-licensed Humira

Study type: Interventional

Funder types: Industry

Identifiers

NCT03970824

CT-P17 1.1

Details and patient eligibility

About

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

Enrollment: 312 patients

Sex: All

Ages: 19 to 55 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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312 participants in 3 patient groups

CT-P17

Experimental group

Description:

a single subcutaneous (SC) injection via pre-filled syringe (PFS)

Treatment:

Biological: CT-P17

US-licensed Humira

Active Comparator group

Description:

a single subcutaneous (SC) injection via pre-filled syringe (PFS)

Treatment:

Biological: US-licensed Humira

EU-approved Humira

Active Comparator group

Description:

a single subcutaneous (SC) injection via pre-filled syringe (PFS)

Treatment:

Biological: EU-approved Humira