drugset / Trial / NCT03735225

Evaluation of the Safety, Tolerability and Bioavailability of Dasiglucagon Following Subcutaneous (SC) Compared to IV Administration

NCT03735225

Phase 1 Completed 60 enrolled Zealand Pharma
RandomizedSequentialQuadruple-blindTreatment

Summary

The purpose of the trial is to characterize the safety and tolerability of dasiglucagon 4 mg/mL following IV administration at increasing doses in healthy volunteers. One cohort of subjects will receive a SC dose of dasiglucagon to characterize the bioavailability of dasiglucagon following SC administration compared to IV administration. Furthermore, the trial aims to assess the potential effect of dasiglucagon on corrected QT interval (QTc) prolongation via a concentrationresponse analysis.

Timeline

Start
2018-11-07
Primary completion
2019-06-24
Completion
2019-06-24

Drugs

EvaluationDrugModalityDoseRoute
Subject Dasiglucagon Peptide 0.1 mg Intravenous
Subject Dasiglucagon Peptide 0.3 mg Intravenous
Subject Dasiglucagon Peptide 0.6 mg Intravenous
Subject Dasiglucagon Peptide 1.5 mg Intravenous
Subject Dasiglucagon Peptide 2 mg Intravenous

Indications