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Trial registered on ANZCTR


Registration number
ACTRN12620000584932
Ethics application status
Approved
Date submitted
20/03/2020
Date registered
20/05/2020
Date last updated
20/05/2020
Date data sharing statement initially provided
20/05/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
CH-ALV-2001: A study assessing variations in how quickly STELARA is processed and
cleared by the body, in healthy adult males.
Scientific title
Open-Label Study to Evaluate the Inter-subject Variability of Single Dose STELARA® Pharmacokinetics, Administered by Subcutaneous Injection in Healthy Adult Males.
Secondary ID [1] 300896 0
None
Universal Trial Number (UTN)
U1111-1248-8000
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Psoriasis 316624 0
Condition category
Condition code
Skin 314859 314859 0 0
Dermatological conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 317099 0
Treatment: Drugs
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 323201 0
Primary PK parameters:
Cmax: maximum serum concentration of ustekinumab
AUC0-t: area under the serum concentration time curve (AUC) of ustekinumab, up to time t, where t is the last time point with concentrations above the lower limit of quantitation (LLOQ)
AUC0-inf: total area under the serum concentration time curve after extrapolation from time t to time infinity, where t is the last time point with a concentration above LLOQ: AUC0-t + Ct/Kel.

Secondary PK parameters:
tmax: time to maximum serum concentration
Kel: elimination rate constant
t½: elimination half-life
Vz/F: volume of distribution
CL/F: apparent clearance.
Timepoint [1] 323201 0
pre-dose
12 hours post-dose
24 hours post-dose
48 hours post-dose
72 hours post-dose
96 hours post-dose
120 hours post-dose
144 hours post-dose
168 hours post-dose
192 hours post-dose
216 hours post-dose
264 hours post-dose
336 hours post-dose
408 hours post-dose
504 hours post-dose
672 hours post-dose
1008 hours post-dose
1344 hours post-dose
1680 hours post-dose
2016 hours post-dose
2256 hours post-dose
2520 hours post-dose
2688 hours post-dose
Secondary outcome [1] 381168 0
To assess the immunogenicity of a single 45 mg SC dose of EU- approved Stelara, administered via PFS in healthy adult male subjects.
Immunogenicity parameters:
Anti-drug antibodies (ADAs) -
Neutralizing antibodies (nAbs)
Both samples are tested using serum assay
Timepoint [1] 381168 0
pre-dose
168 hours post-dose
336 hours post-dose
672 hours post-dose
1344 hours post-dose
2688 hours post-dose
Secondary outcome [2] 381169 0
Adverse events will be assessed at each study visit on Days 1, 2, 3, 4, 5, 6, 7, 8, 9 ,10,12, 15, 18,22,29, 43,57, 71, 85, 95, 106, 113
This assessment will be a combination of physical examination, vital signs, ECGs and safety laboratory results of Hematology, Biochemistry, urinalysis

Common side effects (reported in at least 1 in 100 people, but less than 10 in 100) include:
Upper breathing tract infections (including throat and sinus infections),
Dizziness / headache,
Mouth or throat pain
Diarrhoea / nausea / vomiting
Itchiness
Back pain / muscle pain / joint pain
Tiredness
Redness or pain at the injection site
Uncommon side effects (reported in at least 1 in 1000 people, but less than 1 in 100) include:
Lower breathing tract infections
Herpes / skin infections / dental infections / vaginal thrush infections
Depression
Nasal congestion (stuffy nose)
Acne
injection site reactions
Weakness
Allergic reactions (including rash or hives)
Severe skin reactions
Rare side effects (reported in less than 1 in 1000 people) include:
Serious allergic reactions
Serious lung conditions

Timepoint [2] 381169 0
Assessed at every study visit as follows
Screening, day -1, days 1, 2, 3, 4 ,5, 6, 7, 8 ,9 ,10 ,12, 15, 18, 22, 29, 43, 57, 71, 85, 95, 106, 113
Secondary outcome [3] 381903 0
To evaluate the activity of EU-approved Stelara on different immune T-cell subtypes (T-helper cells) and T-helper cell-related cytokines in peripheral blood,
Timepoint [3] 381903 0
Days 1, 3, 6, 9, 12, 18, 29, 57, 85, 113

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
55 Years
Gender
Males
Can healthy volunteers participate?
Yes
Key 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.


Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 4
Type of endpoint(s)
Pharmacokinetics
Statistical methods / analysis
In general, data will be summarized using descriptive statistics (mean, median, standard deviation, minimum and maximum) or frequency counts and percentages,
Pharmacokinetic Analysis - Listings of individual serum concentrations and PK parameters and graphs of concentration versus time will be prepared. Concentrations and PK parameters will be summarized using descriptive statistics.
Safety Analysis - The number and percentage of subjects experiencing AEs will be summarized using system organ class and preferred term. AEs will be summarized by severity and relationship to study drug. Serious adverse events will be listed separately
Immunogenicity Analysis Immunogenicity data and changes from baseline will be summarised by visit and ADAs and nAbs will be listed.
Exploratory Analysis - T-helper cell and T-helper cell- related cytokine data will be listed. Data and changes from baseline will be summarised.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 22445 0
New Zealand
State/province [1] 22445 0
Canterbury

Funding & Sponsors
Funding source category [1] 305234 0
Commercial sector/Industry
Name [1] 305234 0
Christchurch Clinical Studies Trust
Address [1] 305234 0
264 Antigua Street
Christchurch
8011
Country [1] 305234 0
New Zealand
Primary sponsor type
Commercial sector/Industry
Name
Christchurch Clinical Studies Trust
Address
264 Antigua Street
Christchurch
8011
Country
New Zealand
Secondary sponsor category [1] 305591 0
None
Name [1] 305591 0
Address [1] 305591 0
Country [1] 305591 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305578 0
Southern Health and Disability Ethics Committee
Ethics committee address [1] 305578 0
Ministry of Health
133 Molesworth Street
PO Box 5013
Wellington
6011
Ethics committee country [1] 305578 0
New Zealand
Date submitted for ethics approval [1] 305578 0
27/02/2020
Approval date [1] 305578 0
01/04/2020
Ethics approval number [1] 305578 0

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 100838 0
Dr Chris Wynne
Address 100838 0
Christchurch Clinical studies Trust
264 Antigua Street
Christchurch
8011
Country 100838 0
New Zealand
Phone 100838 0
+64337294764
Fax 100838 0
Email 100838 0
chris@ccst.co.nz
Contact person for public queries
Name 100839 0
Dr Chris Wynne
Address 100839 0
Dr Chris Wynne
Christchurch Clinical studies Trust
264 Antigua Street
Christchurch
8011
Country 100839 0
New Zealand
Phone 100839 0
+64337294764
Fax 100839 0
Email 100839 0
chris@ccst.co.nz
Contact person for scientific queries
Name 100840 0
Dr Chris Wynne
Address 100840 0
Dr Chris Wynne
Christchurch Clinical studies Trust
264 Antigua Street
Christchurch
8011
Country 100840 0
New Zealand
Phone 100840 0
+64337294764
Fax 100840 0
Email 100840 0
chris@ccst.co.nz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
Study protocol
Informed consent form
How or where can supporting documents be obtained?
Type [1] 7414 0
Study protocol
Citation [1] 7414 0
Link [1] 7414 0
Email [1] 7414 0
jo@ccst.co.nz
Other [1] 7414 0
Attachment [1] 7414 0
Type [2] 7415 0
Informed consent form
Citation [2] 7415 0
Link [2] 7415 0
Email [2] 7415 0
jo@ccst.co.nz
Other [2] 7415 0
Attachment [2] 7415 0
Summary results
No Results