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Completed

NCT Number: NCT03970824

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

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

Completed

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Key information

Conditions

Healthy

Age range

19 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

CHA Bundang Medical Center, Seongnam-si, Gyeonggi-do, South Korea

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

CT-P17

Biological

40 mg/0.4ml (100 mg/mL) administered as a single SC injection via PFS

US-licensed Humira

Biological

40 mg/0.4ml (100 mg/mL) administered as a single SC injection via PFS

EU-approved Humira

Biological

40 mg/0.4ml (100 mg/mL) administered as a single SC injection via PFS

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Secondary outcomes

  1. Time to the Maximum Serum Concentration (Tmax)

    Time frame: 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.

  2. Terminal Elimination Half-life (t1/2)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Celltrion

Industry

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2019
Study completion
2020
First posted
Jun 3, 2019
Registry last updated
Nov 18, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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