At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 48 enrolled
Drug / intervention
Recombinant human C1 esterase inhibitor +3 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Double-blind, Placebo-controlled, Ascending Dose, Phase 1 Study to Assess the Safety, Tolerability, and Pharmacokinetics of Single Intravenous and Subcutaneous Doses of Recombinant Human C1 Esterase Inhibitor in Healthy Adult Subjects
In Brief
A Phase 1 clinical trial evaluating Recombinant human C1 esterase inhibitor, Placebo, and 1 other intervention for Hereditary Angioedema (HAE). Completed, enrolled 48 participants across 1 site.
Detailed 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).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHereditary Angioedema (HAE)
CountriesUnited States
Collaborators--
Timeline
Phase 1CompletedFinished
20162017201820192020202120222023202420252026
First PostedJan 2016
Enrollment StartFeb 2016
Primary CompletionDec 2016
TodayJul 2026
First PostedJan 26, 2016
Enrollment StartFeb 19, 2016
Primary CompletionDec 5, 2016
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 10.4 years ago
Interventions
Recombinant human C1 esterase inhibitordrug
Subjects will receive escalating doses I-IV as both IV and SC injections
Placebodrug
Subjects will receive matching placebo
SHP623drug
SHP623
Placebodrug
Placebo