Bioequivalence Healthy volunteers
Conditions
Interventions
Glepaglutide will be administered as an injection under the skin (subcutaneous)
with either a syringe or an autoinjector.
There are two different treatments:
• 10 mg glepaglutide administered with
Sponsors
Zealand Pharma A/S
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Informed consent of the subject has to e obtained before any trial-related activities are performed (trial-related activities are any procedures that would not have been performed during normal management of the subject). 2. Subject has to be a healthy male or female aged between 18 years and 54 years, both inclusive, at screening. 3. Body mass index (BMI)of the subject has to be >20.0 kg/m2 and
Exclusion criteria
Exclusion criteria: 1. Subject cannot have a significant medical history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the Investigator. 2. Subject with a history of colon cancer or a history of other cancers within the last 5 years. 3. The physical examination of the subject should not show clinically significant abnormalities in the standard 12-lead ECG, or vital signs measurements as determined by the Investigator. 4. Clinically significant abnormality in hematology, clinical chemistry, or urinalysis as determined by the Investigator (congenital nonhemolytic hyperbilirubinemia [eg, Gilbert*s syndrome] is acceptable). 5. Subject cannot have a history of significant hypersensitivity, intolerance, suspected hypersensitivity to glepaglutide or related products, or allergy to any drug compound, food, or other substance, unless approved by the Investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| • Cmax = maximum concentration of ZP1848total in plasma • AUC0-t = area under the plasma ZP1848total concentration-time curve (AUC) from time zero to the last time point with a measurable concentration both for the conceptual analyte ZP1848total (glepaglutide + ZP18481-34 + ZP18481-35) in plasma | — |
Secondary
| Measure | Time frame |
|---|---|
| • AUC0-inf = AUC from time 0 extrapolated to infinity • AUC0-t = AUC from time 0 to the last time point with a measurable concentration in plasma for ZP1848 and main metabolite ZP18481-34 • Cmax = maximum concentration of ZP1848 and ZP18481 34 in plasma • Tmax = time to attain Cmax • *z = terminal elimination phase rate constant • t1/2 = terminal elimination half-life all for the conceptual analyte ZP1848total and main metabolite ZP18481 34 in plasma • Adverse events Safety: • Change from baseline in: o Clinical laboratory values (hematology, clinical chemistry, and urinalysis) o Standard 12-lead electrocardiogram (ECG) evaluation o Vital signs (diastolic and systolic blood pressure, heart rate, and body temperature) o Physical examination evaluation Immunogenicity • Overall anti-glepaglutide antibody incidences (treatment-induced and treatment-boosted) and titers • Antibodies reacting to the main metabolite (ZP18481-34) • Antibodies cross-reacting to endogenous GLP-2 • Glepaglutide neutralizing antibodies | — |
Countries
Netherlands
Outcome results
None listed