Single Dose Escalation Study of P1101 in Healthy Adult Male Subjects

The primary objectives were to determine the safety and tolerability of single ascending subcutaneous doses of P1101 and to determine the pharmacokinetics of P1101 in single ascending subcutaneous doses of P1101 in healthy male subjects.

The secondary objectives were to evaluate the occurrence of side effects in healthy subjects receiving either P1101 or PEGASYS; to compare the pharmacokinetic parameters for P1101 and PEGASYS; and to assess the effect of P1101 on the biomarkers 2',5' oligoadenylate synthetase and neopterin.

A total of 48 subjects were enrolled to receive subcutaneous injection of P1101 in the dose level of 24 , 48 , 90 , 180 , 225 , or 270 mcg or to receive subcutaneous injection of 180 mcg Pegasys.

Main Inclusion Criteria:

• Be healthy males, non-smokers, ≥18 and ≤45 years of age;
• Able to attend all scheduled visits and to comply with all study procedures.

Main Exclusion Criteria:

• Clinically significant illness or surgery within 4 weeks prior to dosing;
• Any clinically significant abnormality or abnormal laboratory test results found during screening;
• Positive test for hepatitis B, hepatitis C, or HIV at screening;
• Clinically significant vital sign abnormalities at screening;
• History of significant alcohol or drug abuse within one year prior to the screening visit;
• History of severe allergic or hypersensitivity reactions;
• Use of an investigational drug or participation in an investigational drug trial within the last 4 weeks;
• Any clinically significant history or presence of neurological, cardiovascular, pulmonary, hematological, immunologic, metabolic or other uncontrolled systemic disease;
• Clinically significant history or known presence of psychiatric disorders, including but not limited to depression, anxiety, and sleep disorders;
• Body organ transplant and are taking immunosuppressants;
• History of malignant disease;
• History or presence of endocrine disorders;
• History of coagulation disorders and blood dyscrasias;
• Inability to comprehend the written consent form.