Effects of TT301 on Cytokine Levels Post Endotoxin Challenge
- Registration Number
- NCT01357421
- Lead Sponsor
- OPKO Health, Inc.
- Brief Summary
This study will evaluate the effects of TT301 on cytokine levels in healthy male volunteers participating in an endotoxin challenge.
- Detailed Description
The LPS human endotoxemia model results in a well characterized, transient acute inflammatory response. The model has been widely used for decades as a system to study new therapeutic agents for inflammation before wider clinical studies are undertaken. This study will evaluate the effects of TT301 on cytokine levels in healthy male volunteers participating in an endotoxin challenge.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 18
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description TT301 TT301 Investigational drug TT301 Placebo Placebo Normal saline
- Primary Outcome Measures
Name Time Method Cytokine levels post LPS challenge Measured up to 12h post-LPS
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Duke Clinical Research Unit
🇺🇸Durham, North Carolina, United States