Effects of TT301 on Cytokine Levels Post Endotoxin Challenge

Completed · Phase 1 · Has a placebo group

Conditions studied: Traumatic Brain Injury

In brief

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

Key facts

Study ID

NCT01357421

Run by

OPKO Health, Inc.

People needed

18

Starts

2011-05-01

Expected to finish

2011-06-01

Last updated by the study team

2013-06-06

Who can join

Age: 18 and older, up to 40. Sex: male. Healthy volunteers: accepted.

You may qualify if…

• Male
• 18 to 40 years, inclusive
• 55 - 95 kg, inclusive

You may not qualify if…

• 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

Where it is running

• Duke Clinical Research Unit — Durham, North Carolina, United States

Full record on ClinicalTrials.gov

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