NCT03970824

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
312

participants targeted

Target at P75+ for phase_1 healthy

Timeline
Completed

Started May 2019

Typical duration for phase_1 healthy

Geographic Reach
1 country

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 20, 2019

Completed
11 days until next milestone

Study Start

First participant enrolled

May 31, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 3, 2019

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 13, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2020

Completed
11 months until next milestone

Results Posted

Study results publicly available

December 11, 2020

Completed
Last Updated

November 18, 2021

Status Verified

November 1, 2021

Enrollment Period

6 months

First QC Date

May 20, 2019

Results QC Date

November 12, 2020

Last Update Submit

November 17, 2021

Conditions

Healthy

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (2)

  • Time to the Maximum Serum Concentration (Tmax)

    up to Day 71

  • Terminal Elimination Half-life (t1/2)

    up to Day 71

Study Arms (3)

CT-P17

EXPERIMENTAL

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

Biological: CT-P17

US-licensed Humira

ACTIVE COMPARATOR

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

Biological: US-licensed Humira

EU-approved Humira

ACTIVE COMPARATOR

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

Biological: EU-approved Humira

Interventions

CT-P17BIOLOGICAL

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

CT-P17
US-licensed HumiraBIOLOGICAL

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

US-licensed Humira
EU-approved HumiraBIOLOGICAL

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

EU-approved Humira

Eligibility Criteria

Age19 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy subjects
  • BMI between 18.0 and 29.9 kg/m2, both inclusive, when rounded to the nearest tenth

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

CHA Bundang Medical Center

Seongnam-si, Gyeonggi-do, 13520, South Korea

Location

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 13620, South Korea

Location

Chonbuk National University Hospital

Jeonju, Jeollabuk-do, 54907, South Korea

Location

Chungbuk National University Hospital

Cheongju-si, North Chungcheong, 28644, South Korea

Location

Inje University Busan Paik Hospital

Busan, 47392, South Korea

Location

Chungnam National University Hospital

Daejeon, 35015, South Korea

Location

Seoul National University Hospital

Seoul, 03080, South Korea

Location

Severance Hospital

Seoul, 03722, South Korea

Location

Asan Medical Center

Seoul, 05505, South Korea

Location

Related Publications (1)

  • 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.

    PMID: 33503313DERIVED

MeSH Terms

Interventions

CT-P17

Results Point of Contact

Title
SungHyun Kim
Organization
CELLTRION, Inc.
SungHyun.Kim@celltrion.com
+82 32 850 5778

Study Officials

  • Sang Joon Lee

    Celltrion, Inc.

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 20, 2019

First Posted

June 3, 2019

Study Start

May 31, 2019

Primary Completion

November 13, 2019

Study Completion

January 15, 2020

Last Updated

November 18, 2021

Results First Posted

December 11, 2020

Record last verified: 2021-11

Data Sharing

IPD Sharing
Will not share

Locations

KR(9)