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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT04428814




Registration number
NCT04428814
Ethics application status
Date submitted
8/06/2020
Date registered
11/06/2020
Date last updated
5/08/2021

Titles & IDs
Public title
Study to Compare PK and Safety of Subcutaneous Injection of Ustekinumab and CT-P43 in Healthy Subjects
Scientific 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
Secondary ID [1] 0 0
CT-P43 1.1
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Healthy Subjects 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - CT-P43
Other interventions - EU-approved Stelara
Other interventions - US-licensed Stelara

Experimental: CT-P43 (Part 1) - 45mg single dose administration

Active Comparator: EU-approved Stelara (Part 1) - 45mg single dose administration

Experimental: CT-P43 (Part 2) - 45mg single dose administration

Active Comparator: EU-approved Stelara (Part 2) - 45mg single dose administration

Active Comparator: US-licensed Stelara (Part 2) - 45mg single dose administration


Other interventions: CT-P43
45mg single dose

Other interventions: EU-approved Stelara
45mg single dose

Other interventions: US-licensed Stelara
45mg single dose
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Demonstrate PK similarity
Timepoint [1] 0 0
through study completion, up to day 127
Primary outcome [2] 0 0
Demonstrate PK similarity
Timepoint [2] 0 0
through study completion, up to day 127

Eligibility
Key inclusion criteria
1. Healthy male subjects, between the ages of 18 and 55 years.

2. Subject with a BMI between 18.5 and 29.9 kg/m2. Weight between 60 to 100 kg.

3. 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.

4. 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.
Minimum age
18 Years
Maximum age
55 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Subject has a prohibited medical history and/or current condition.

2. Subject is planning to father a child or donate sperm within 18 weeks after the
administration of the study drug (Day 1).

3. Subject previously received any biologic agents

4. In the opinion of the investigator, the subject is not eligible for the study
participation for any reason.

5. Subject is vulnerable.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
3/08/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
24/02/2021
Sample size
Target
Accrual to date
Final
271
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Auckland
Country [2] 0 0
New Zealand
State/province [2] 0 0
Canterbury

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Celltrion
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT04428814
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries