Safety, Pharmacokinetics, and Pharmacodynamics of ARC1779 in Healthy Volunteers

A Phase 1, Single-Site, Double-Blind,Randomized, Dose Escalation Study of the Safety, Pharmacokinetics, and Pharmacodynamics of Intravenous Bolus or Intravenous Bolus Followed by Continuous Infusion Administration of ARC1779 Compared to Placebo in Healthy Volunteers

The purpose of this study is to establish the overall safety and tolerability of ARC1779 in healthy volunteers, and to characterize its pharmacokinetic and pharmacodynamic profile with respect to parameters of platelet function and von Willebrand Factor activity.

The purpose of this study is to establish the overall safety and tolerability of ARC1779 in healthy volunteers, and to characterize its pharmacokinetic and pharmacodynamic profile with respect to parameters of platelet function and von Willebrand Factor activity.

Inclusion Criteria:

• ≥ 18 to ≤ 65 years of age
• Weight ≤ 110 kg
• Negative qualitative urine drug/alcohol test
• Female volunteers must be of non-childbearing potential
• Male volunteers must agree to use a medically acceptable contraceptive
• Volunteers must be capable of understanding and complying with the protocol and must have signed the informed consent document

Exclusion Criteria:

Any clinically significant medical disorder (e.g. diabetes, hypertension, etc.)

• Tendency to bleed easily
• History of recent trauma or surgery
• History of gout or renal stones

Clinically significant abnormal lab parameters for the following:

• PT INR > 1.4
• aPTT > reference laboratory values
• Serum creatinine > 1.3 mg/dL
• Platelet count of ≤ 100,000/mm3
• ALT/AST > 2 times ULN
• WBC ≤ 3000 x 109/L
• Hemoglobin < 11 g/dL
• Total bilirubin > 1.2 mg/dL
• CBT > 15 min