Clinical trial NCT03970824: To Compare the Pharmacokinetics and Safety of CT-P17 and Humira in Healthy Subjects
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Celltrion
Sponsor class: INDUSTRY
First posted: 2019-06-03
Enrollment: 312
Sex: ALL
Minimum age (years): 19
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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


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)

Primary outcomes:
measure: Area Under the Concentration-time Curve From Time Zero to Infinity (AUC0-inf)
timeFrame: up to Day 71
measure: Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUC0-last)
timeFrame: up to Day 71
measure: Maximum Serum Concentration (Cmax)
timeFrame: up to Day 71
Secondary outcomes:
measure: Time to the Maximum Serum Concentration (Tmax)
timeFrame: up to Day 71
measure: Terminal Elimination Half-life (t1/2)
timeFrame: up to Day 71
Other outcomes:
Locations:
city: Cheongju-si
country: Korea, Republic of
facility: Chungbuk National University Hospital
state: Chungcheongbuk-do
city: Seongnam-si
country: Korea, Republic of
facility: CHA Bundang Medical Center
state: Gyeonggi-do
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggi-do
city: Jeonju
country: Korea, Republic of
facility: Chonbuk National University Hospital
state: Jeollabuk-do
city: Busan
country: Korea, Republic of
facility: Inje University Busan Paik Hospital
city: Daejeon
country: Korea, Republic of
facility: Chungnam National University Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
Study officials:
affiliation: Celltrion, Inc.
name: Sang Joon Lee
role: STUDY_DIRECTOR
References:
citation: Yu KS, Jang IJ, Lim HS, Hong JH, Kim MG, Park MK, Cho DY, Park MS, Chung JY, Ghim JL, Lee S, Yoon SK, Kwon IS, Lee SJ, Kim SH, Bae YJ, Cha JB, Furst DE, Keystone E, Kay J. Pharmacokinetic equivalence of CT-P17 to high-concentration (100 mg/ml) reference adalimumab: A randomized phase I study in healthy subjects. Clin Transl Sci. 2021 Jul;14(4):1280-1291. doi: 10.1111/cts.12967. Epub 2021 Mar 2.