Conditions: Hereditary Angioedema (HAE)
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 48
Healthy volunteers: yes

Brief summary:
This trial is looking to gain information about the safety and tolerability of an investigational treatment (SHP623) in healthy adult volunteers. This study will also collect pharmacokinetic data (how the body absorbs and breaks down the study drug).

Detailed description:

Arms:
arm 1: Treatment A: 9 Subjects will receive dose level I of SHP623 intravenously (IV). B: 9 Subjects will receive dose level I of SHP623 subcutaneously(SC). arm 2: 3 Subjects will receive placebo for each cohort

Interventions: intervention 1: Recombinant human C1 esterase inhibitor intervention 2: Placebo intervention 3: SHP623 intervention 4: Placebo
Intervention descriptions: intervention 1: Subjects will receive escalating doses I-IV as both IV and SC injections intervention 2: Subjects will receive matching placebo intervention 3: SHP623 intervention 4: Placebo

Protocol document: