CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 38 enrolled
Drug / intervention
DX-2930 +1 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.

Search/NCT02093923
NCT02093923Phase 1Completed
CompareCT.gov

A Phase 1b, Double-Blind, Multiple Ascending Dose Study to Assess Safety, Tolerability and Pharmacokinetics of DX-2930 in Hereditary Angioedema Subjects

Shire·interventional·Posted Mar 21, 2014·Updated May 27, 2021

In Brief

A Phase 1 clinical trial evaluating DX-2930 and Placebo for Hereditary Angioedema (HAE). Completed, enrolled 38 participants across 14 sites in 3 countries.

Detailed Summary

The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics (PK) profile of multiple subcutaneous administrations of DX-2930 across a range of doses in HAE participants.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHereditary Angioedema (HAE)
CountriesItaly, Jordan, United States
Collaborators--

Timeline

Phase 1CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedMar 21, 2014
Enrollment StartMay 14, 2014
Primary CompletionMay 18, 2015
TodayJul 2, 2026
Enrollment to primary: 1.0 yearsPosted 12.3 years ago

Interventions

DX-2930drug

Participants will receive SC injection of DX-2930 (a recombinant, Chinese hamster ovary \[CHO\] cell expressed, fully human immunoglobulin IgG1, kappa light chain, monoclonal antibody) once and followed by the second dose after 2 week into the upper arm.

Placebodrug

Participants will receive matching placebo subcutaneously.