ulcerative colitis and Crohn's disease and pouchitis Ulcerative colitis and pouchitis
Conditions
Interventions
The planned dose levels for the study are as follows:
The (up to) 120 volunteers will receive one of three treatments on Day 1 once:
27 to 40 : PB016, intravenous infusion, 300 mg
27 to 40: EU-appro
Sponsors
Polpharma Biologics S.A.
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Using the intravenous (IV) presentation: • To demonstrate pharmacokinetic (PK) comparability of PB016 to US licensed Entyvio® in terms of AUC0 last of vedolizumab • To demonstrate PK comparability of PB016 to EU approved Entyvio® in terms of AUC0-last of vedolizumab • To demonstrate PK comparability of EU approved Entyvio® to US-licensed Entyvio® in terms of AUC0-last of vedolizumab for scientific bridge • To demonstrate PK comparability of PB016 to US licensed Entyvio® in terms of AUC0 inf of vedolizumab • To demonstrate PK comparability of PB016 to EU approved Entyvio® in terms of AUC0 inf of vedolizumab • To demonstrate PK comparability of EU approved Entyvio® to US-licensed Entyvio® in terms of AUC0-inf of vedolizumab for scientific bridge | — |
Secondary
| Measure | Time frame |
|---|---|
| • To demonstrate PK comparability of PB016 to US licensed Entyvio® in terms of Cmax of vedolizumab • To demonstrate PK comparability of PB016 to EU approved Entyvio® in terms of Cmax of vedolizumab • To demonstrate PK comparability of EU approved Entyvio® to US-licensed Entyvio® in terms of Cmax of vedolizumab • To support comparable PK profiles of PB016 with US-licensed Entyvio® and with EU approved Entyvio in terms of tmax, t1/2, and clearance • To support comparable immunogenicity profiles of PB016 with US-licensed Entyvio® and with EU approved Entyvio® • To support comparable safety and tolerability profiles of PB016 and both US licensed Entyvio® and EU approved Entyvio® | — |
Countries
Netherlands
Outcome results
None listed