A single dose, randomised, double-blind 3-arm parallel-group study to compare the pharmacokinetics and a4β7 receptor saturation, for PB016 versus US-licensed and EU-approved Entyvio® after intraveneous administration in healthy subjects
- Conditions
- ulcerative colitis and Crohn's disease and pouchitisUlcerative colitis and pouchitis10018027
- Registration Number
- NL-OMON53409
- Lead Sponsor
- Polpharma Biologics S.A.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 84
1. Sex: male or female.
2. Age: 18 years to 65 years, inclusive, at screening.
3. Body mass index (BMI): 18.5 kg/m2 to 30.0 kg/m2, inclusive, at screening.
4. Status: healthy subjects.
5. The subject is healthy at screening as determined by their medical history,
physical examination, vital signs, an ECG, and clinical laboratory testing as
judged by the Investigator.
Further criteria apply
1. Any known prior exposure to vedolizumab or any other therapeutic mAb or any
other B- and T-cell targeting therapies provided with biological drugs 4 months
before study.
2. Any known exposure to immunosuppressive or immunomodulatory synthetic drugs
or other synthetic drugs with known immunosuppressive or immunomodulatory
action (eg, methotrexate, cyclosporine, azathioprine, mitoxantrone, tacrolimus)
within 3 months before study.
3. Known or suspected hypersensitivity to vedolizumab, or any components of the
formulation used (citric acid monohydrate, sodium citrate dihydrate,
L-histidine, L histidine monohydrochloride, larginine hydrochloride,
polysorbate 80).
4. Any exposure to steroids within one month prior to dosing, to agents such as
interferon-β, glatiramer acetate, fingolimod, or laquinimod within the last 2
months, to teriflunomide during the last 3.5 months, or to dimethyl fumarate
within 6 months prior to dosing.
5. Plasma exchange within 3 weeks prior to dosing.
Further criteria apply
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Using the intravenous (IV) presentation:<br /><br>• To demonstrate pharmacokinetic (PK) comparability of PB016 to US licensed<br /><br>Entyvio® in terms of AUC0 last of vedolizumab<br /><br>• To demonstrate PK comparability of PB016 to EU approved Entyvio® in terms of<br /><br>AUC0-last of vedolizumab<br /><br>• To demonstrate PK comparability of EU approved Entyvio® to US-licensed<br /><br>Entyvio® in terms of AUC0-last of vedolizumab for scientific bridge<br /><br>• To demonstrate PK comparability of PB016 to US licensed Entyvio® in terms of<br /><br>AUC0 inf of vedolizumab<br /><br>• To demonstrate PK comparability of PB016 to EU approved Entyvio® in terms of<br /><br>AUC0 inf of vedolizumab<br /><br>• To demonstrate PK comparability of EU approved Entyvio® to US-licensed<br /><br>Entyvio® in terms of AUC0-inf of vedolizumab for scientific bridge</p><br>
- Secondary Outcome Measures
Name Time Method <p>• To demonstrate PK comparability of PB016 to US licensed Entyvio® in terms of<br /><br>Cmax of vedolizumab<br /><br>• To demonstrate PK comparability of PB016 to EU approved Entyvio® in terms of<br /><br>Cmax of vedolizumab<br /><br>• To demonstrate PK comparability of EU approved Entyvio® to US-licensed<br /><br>Entyvio® in terms of Cmax of vedolizumab<br /><br>• To support comparable PK profiles of PB016 with US-licensed Entyvio® and with<br /><br>EU approved Entyvio in terms of tmax, t1/2, and clearance<br /><br>• To support comparable immunogenicity profiles of PB016 with US-licensed<br /><br>Entyvio® and with EU approved Entyvio®<br /><br>• To support comparable safety and tolerability profiles of PB016 and both US<br /><br>licensed Entyvio® and EU approved Entyvio® </p><br>