Conditions: Hereditary Angioedema (HAE)
Keywords: HAE
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 38
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: Participants will receive 30 milligram (mg) dose of DX-2930 subcutaneous (SC) injection once and followed by the second dose after 2 week into the upper arm. arm 2: Participants will receive 100 mg dose of DX-2930 SC injection once and followed by the second dose after 2 week into the upper arm. arm 3: Participants will receive 300 mg dose of DX-2930 SC injection once and followed by the second dose after 2 week into the upper arm. arm 4: Participants will receive 400 mg dose of DX-2930 subcutaneous (SC) injection once and followed by the second dose after 2 week into the upper arm. arm 5: Participants will receive placebo matched to 30, 100, 300 and 400 mg dose of DX-2930 SC injection once and followed by the second dose after 2 week into the upper arm.

Interventions: intervention 1: DX-2930 intervention 2: Placebo
Intervention descriptions: intervention 1: 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. intervention 2: Participants will receive matching placebo subcutaneously.

Protocol document: