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

NCT04428814 | Completed Phase 1

• 1 other identifier: CT-P43 1.1
• Study Type: interventional
• Target: 271
• Locations: 1 country
• Sites: 2

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.

Conditions

Healthy Subjects

Outcome Measures

Primary Outcomes (2)

• Demonstrate PK similarity

  under the concentration-time curve from time zero to infinity (AUC0-inf) of CT-P43, EU-approved Stelara, and US-licensed Stelara

  through study completion, up to day 127

• Demonstrate PK similarity

  maximum serum concentration (Cmax) of CT-P43, EU-approved Stelara, and US-licensed Stelara

  through study completion, up to day 127

Study Arms (5)

CT-P43 (Part 1)

EXPERIMENTAL

45mg single dose administration

Biological: CT-P43

EU-approved Stelara (Part 1)

ACTIVE COMPARATOR

45mg single dose administration

Biological: EU-approved Stelara

CT-P43 (Part 2)

EXPERIMENTAL

45mg single dose administration

Biological: CT-P43

EU-approved Stelara (Part 2)

ACTIVE COMPARATOR

45mg single dose administration

Biological: EU-approved Stelara

US-licensed Stelara (Part 2)

ACTIVE COMPARATOR

45mg single dose administration

Biological: US-licensed Stelara

Interventions

CT-P43 BIOLOGICAL

45mg single dose

CT-P43 (Part 1); CT-P43 (Part 2)

EU-approved Stelara BIOLOGICAL

45mg single dose

EU-approved Stelara (Part 1); EU-approved Stelara (Part 2)

US-licensed Stelara BIOLOGICAL

45mg single dose

US-licensed Stelara (Part 2)

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Celltrion: lead

Study Sites (2)

Auckland Clinical Studies Limited

Grafton, Auckland, 1010, New Zealand

Location

Christchurch Clinical Studies Trust Limited

Christchurch, Canterbury, 8011, New Zealand

Location

Study Design

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

Study Record Dates

• First Submitted: June 8, 2020
• First Posted: June 11, 2020
• Study Start: August 3, 2020
• Primary Completion: February 24, 2021
• Study Completion: February 24, 2021
• Last Updated: August 5, 2021

Record last verified: 2021-08

Locations

NZ (2)