NCT02093923

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 38 (actual)
• Sponsor: Shire · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hereditary Angioedema (HAE)

Interventions

Type	Name	Description
DRUG	DX-2930	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.
DRUG	Placebo	Participants will receive matching placebo subcutaneously.

Timeline

• Start date: 2014-05-14
• Primary completion: 2015-05-18
• Completion: 2015-05-18
• First posted: 2014-03-21
• Last updated: 2021-05-27
• Results posted: 2016-08-01

Locations

14 sites across 3 countries: United States, Italy, Jordan