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

NCT04428814 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 271

Last updated 2021-08-05

No results posted yet for this study

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

Interventions

BIOLOGICAL

CT-P43

45mg single dose

BIOLOGICAL

EU-approved Stelara

45mg single dose

BIOLOGICAL

US-licensed Stelara

45mg single dose

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-08-03
Primary Completion
2021-02-24
Completion
2021-02-24

Countries

  • New Zealand

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04428814 on ClinicalTrials.gov