Single Dose Escalation Study of P1101 in Healthy Adult Male Subjects

• Status: Completed
• Trial end date: 2010-06-26
• Target enrollment: 0
• Participant gender: Male

Summary

This was a single-center, double-blind, randomized, active control, single dose escalation study to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) profiles of P1101 in 48 healthy volunteers.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: PharmaEssentia
• Treatments: Peginterferon alfa-2a

Criteria

Main Inclusion Criteria:

1. Be healthy males, non-smokers, ≥18 and ≤45 years of age;

2. Able to attend all scheduled visits and to comply with all study procedures.

Main Exclusion Criteria:

1. Clinically significant illness or surgery within 4 weeks prior to dosing;

2. Any clinically significant abnormality or abnormal laboratory test results found during screening;

3. Positive test for hepatitis B, hepatitis C, or HIV at screening;

4. Clinically significant vital sign abnormalities at screening;

5. History of significant alcohol or drug abuse within one year prior to the screening visit;

6. History of severe allergic or hypersensitivity reactions;

7. Use of an investigational drug or participation in an investigational drug trial within the last 4 weeks;

8. Any clinically significant history or presence of neurological, cardiovascular, pulmonary, hematological, immunologic, metabolic or other uncontrolled systemic disease;

9. Clinically significant history or known presence of psychiatric disorders, including but not limited to depression, anxiety, and sleep disorders;

10. Body organ transplant and are taking immunosuppressants;

11. History of malignant disease;

12. History or presence of endocrine disorders;

13. History of coagulation disorders and blood dyscrasias;

14. Inability to comprehend the written consent form.