Phase 1 Study to Assess the Safety, Tolerability, and Pharmacokinetics of Recombinant Human C1 Esterase Inhibitor in Healthy Adult Subjects

Inclusion Criteria:

1. Must be considered healthy. Healthy status is defined by absence of evidence of any
active or chronic disease

2. Male, or non-pregnant, non-lactating female, who agrees to comply with any applicable
contraceptive requirements of the protocol, or females of non-child-bearing potential.

3. Body mass index between 18.0 and 30.0 kg/m2 inclusive with a body weight >50 kg (110
lbs.). This inclusion criterion will be assessed only at the first screening visit.

4. Hemoglobin ≥12.0g/ld.

Exclusion Criteria:

1. Have a history of allergic reaction to C1 INH products (e.g. C1 Inhibitor [Human],
Berinert [C1 Estrace Inhibitor (Human)] and C1 estrace [recombinant]

2. Known history of alcohol or other substance abuse within the last year.

3. Donation of blood or blood products within 60 days prior to receiving investigational
product.

4. Current use of any medication except hormonal replacement therapy, hormonal
contraceptives and occasional use of any over-the-counter non-steroidal
anti-inflammatory drug (NSAID) or acetaminophen.

5. Have a history of hypercoagulability or other predisposition to thrombotic events.