No treatment-induced or treatment-boosted antidrug antibodies occurred in the repeated-dose dasiglucagon trial.
In plain wordsThe repeated-dose dasiglucagon trial detected no new or increased antidrug antibodies.
- Peptide
- Dasiglucagon
- Outcome
- Not applicableAntidrug antibodies
- Study
n = 112
- Analysis
- Primary
- Outcome group
- Immune response · Immune and inflammation
- Studied dose
- 0.6 mg weekly for three doses · subcutaneous · three consecutive weekly dosesAs given in this study (human).
Measurements
- ADA incidence
- 0
- overall trial
Source sentences
For the primary immunogenicity endpoint, the overall ADA incidence was zero, as no subject demonstrated any treatment-induced or treatment-boosted ADA response at any time point in this trial involving three consecutive weekly doses of trial drug.
2 context sentences(design, population, supporting numbers)
A total of 112 subjects were randomized 1:1 to receive three subcutaneous weekly doses of either 0.6 mg dasiglucagon or 1.0 mg recombinant glucagon (GlucaGen®) according to a double-blind parallel-group trial design.
Subjects were followed for 15 weeks, with a multitiered testing approach planned for assessment of antidrug antibody (ADA) formation.