None listed
Conditions
Brief summary
Single-center, single-arm, open-label study of EU-approved Stelara administered subcutaneously in healthy adult subjects. The study is designed to provide single-dose pharmacokinetic inter-subject variability data for Stelara, to optimize study design (including sample size calculation) for a proposed ustekinumab biosimilar pivotal PK study.
Interventions
Approximately 22 healthy men will each receive a single 45 mg dose of Stelara, as an injection under the skin in the abdomen. The SC injection will be given by a registered nurse.
Sponsors
Christchurch Clinical Studies Trust
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
Male
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
Male, Resting supine systolic blood pressure (BP) of < 150 mmHg and diastolic BP of < 90 mmHg at screening. Other vital signs showing no clinically significant abnormalities, in the opinion of the Investigator. No clinically significant abnormalities on 12-lead electrocardiogram (ECG) recording at screening and Day -1, in the opinion of the Investigator. Non-smoker, or smoker of less than 10 cigarettes per day within 3 months prior to Day 1. Smokers must be able to abide by the smoking policy of the site. Must (with any female partner of childbearing potential) use effective contraception per section 4.5.1 of the protocol, or be practicing complete abstinence, from screening through until at least 16 weeks after IP administration.
Exclusion criteria
Any clinically significant concomitant disease or condition that could interfere with, or for which the treatment of might interfere with, the conduct of the study, or that would, in the opinion of the Investigator, pose an unacceptable risk to the subject in this study. Clinically relevant medical or psychiatric disorder in the opinion of the Investigator, including but not limited to malignancies, demyelinating disorders, herpes zoster, hepatobiliary disorders, pancreatic diseases and congestive heart failure. History of relevant drug and/or food allergies, or allergic reactions attributed to latex, or to compounds of similar chemical or biologic composition to agent used in study. Clinically significant atopy (childhood asthma is permitted). Infection requiring hospitalization or intravenous antibiotic use within 6 months prior to Day 1, infection requiring oral or systemic antibiotic within 4 weeks prior to Day 1. Any current infection or history of recurrent or chronic infections. History or evidence of invasive systemic fungal infections (including histoplasmosis, coccidioidomycosis, candidiasis, aspergillosis, blastomycosis, and pneumocystosis, etc.) or other opportunistic infections judged to be significant by the Investigator. Positive QuantiFERON-TB Gold (QFT-G) test for tuberculosis (TB) during screening. In the event of an indeterminate QFT-G, a single retest will be permitted during the Screening period. If the repeat result is indeterminate or positive, the subject will be excluded from the study. Previous exposure to any therapeutic agent targeted against interleukin (IL)-12 or IL-23.
Outcome results
None listed