Effects of TT301 on Cytokine Levels Post Endotoxin Challenge

• Status: Completed
• Trial end date: 2011-06-01
• Target enrollment: 0
• Participant gender: Male

Summary

This study will evaluate the effects of TT301 on cytokine levels in healthy male volunteers participating in an endotoxin challenge.

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

Details

• Lead Sponsor: OPKO Health, Inc.; Transition Therapeutics

Criteria

Inclusion Criteria:

• Male

• 18 to 40 years, inclusive

• 55 - 95 kg, inclusive

Exclusion Criteria:

• Evidence of any clinically significant disease

• History of cancer

• History of syncope or severe vasovagal events

• Antibiotic treatment within 60 days of Day 1

• Surgical procedure within 60 days of Day 1

• Hepatitis C, Hepatitis B

• Tuberculosis

• HIV

• Requirement for medications (prescription/OTC) during the study

• Donated > 250 mL blood within 30 days of Day 1

• Donated > 750 mL blood within 60 days of Day 1

• In a clinical trial of an immunosuppressive drug within 6 months of Day 1

• Received any vaccination within 6 months of Day 1

• Any clinically important allergy

• Known allergy/sensitivity to lactose and/or polyethylene glycol