Study to Compare PK and Safety of Subcutaneous Injection of Ustekinumab and CT-P43 in Healthy Subjects

Sponsor

Celltrion (Industry)

Overall Status

Completed

CT.gov ID

NCT04428814

Collaborator

(none)

271

Enrollment

Locations

Arms

6.7

Actual Duration (Months)

135.5

Patients Per Site

20.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study is a Phase 1, 2-Part, Randomized, Double-Blind, Parallel-Group, Single-Dose Study to Compare the Pharmacokinetics, Safety and Immunogenicity of Three Subcutaneous Injection Formulations of Ustekinumab (CT-P43, EU approved Stelara, and US licensed Stelara) in Healthy Male Subjects.

Condition or Disease	Intervention/Treatment	Phase
Healthy Subjects	Biological: CT-P43 Biological: EU-approved Stelara Biological: US-licensed Stelara	Phase 1

Detailed Description

CT-P43 is being developed as a proposed biosimilar of Stelara (ustekinumab). This study will be conducted in 2 parts. In Part 1, subjects will be enrolled and randomized in a 1:1 ratio to receive a single dose (45 mg) of either CT-P43 or EU-approved Stelara to collect preliminary safety data for CT-P43. In Part 2, subjects will be enrolled and randomized in a 1:1:1 ratio to receive a single dose (45 mg) of CT-P43, EU-approved Stelara, or US-licensed Stelara to demonstrate PK similarity. Each part will proceed independently, and subjects will be randomized to either Part 1 or Part 2 of the study subsequently. All subjects in Part 1 and Part 2 will undergo the same assessments. In each treatment arm in Part 1 and Part 2, all subjects will receive a study drug subcutaneously via PFS. The randomization to treatment assignment will be stratified by study center and body weight as measured at baseline to balance subject weight across treatment groups. Subjects will be confined to the study center until all required 24-hour post-dose assessments have been completed and will be discharged on Day 2. Subsequent visits will be carried out on an out-patient basis up to EOS.

Study Design

Study Type:

Interventional

Actual Enrollment :

271 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

A Phase 1, 2-Part, Randomized, Double-Blind, Parallel-Group, Single-Dose Study to Compare the Pharmacokinetics, Safety and Immunogenicity of Three Subcutaneous Injection Formulations of Ustekinumab in Healthy Male Subjects

Actual Study Start Date :

Aug 3, 2020

Actual Primary Completion Date :

Feb 24, 2021

Actual Study Completion Date :

Feb 24, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: CT-P43 (Part 1) 45mg single dose administration	Biological: CT-P43 45mg single dose
Active Comparator: EU-approved Stelara (Part 1) 45mg single dose administration	Biological: EU-approved Stelara 45mg single dose
Experimental: CT-P43 (Part 2) 45mg single dose administration	Biological: CT-P43 45mg single dose
Active Comparator: EU-approved Stelara (Part 2) 45mg single dose administration	Biological: EU-approved Stelara 45mg single dose
Active Comparator: US-licensed Stelara (Part 2) 45mg single dose administration	Biological: US-licensed Stelara 45mg single dose

Outcome Measures

Primary Outcome Measures

Demonstrate PK similarity [through study completion, up to day 127]
under the concentration-time curve from time zero to infinity (AUC0-inf) of CT-P43, EU-approved Stelara, and US-licensed Stelara
Demonstrate PK similarity [through study completion, up to day 127]
maximum serum concentration (Cmax) of CT-P43, EU-approved Stelara, and US-licensed Stelara

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Healthy male subjects, between the ages of 18 and 55 years.
Subject with a BMI between 18.5 and 29.9 kg/m2. Weight between 60 to 100 kg.
Subject must agree to use medically acceptable methods of contraception consistent with local regulations during the course of the study and for 18 weeks after administration of the study drug.
Subject is informed and able to understand the full nature and purpose of the study, including possible risks and side effects, and is given ample time and opportunity to read and understand this information.

Exclusion Criteria:

Subject has a prohibited medical history and/or current condition.
Subject is planning to father a child or donate sperm within 18 weeks after the administration of the study drug (Day 1).
Subject previously received any biologic agents
In the opinion of the investigator, the subject is not eligible for the study participation for any reason.
Subject is vulnerable.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Auckland Clinical Studies Limited	Grafton	Auckland	New Zealand	1010
2	Christchurch Clinical Studies Trust Limited	Christchurch	Canterbury	New Zealand	8011

Sponsors and Collaborators

Celltrion

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Celltrion

ClinicalTrials.gov Identifier:

NCT04428814

Other Study ID Numbers:

CT-P43 1.1

First Posted:

Jun 11, 2020

Last Update Posted:

Aug 5, 2021

Last Verified:

Aug 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Ustekinumab

Study Results

No Results Posted as of Aug 5, 2021