Effects of TT301 on Cytokine Levels Post Endotoxin Challenge
Status and phase
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Treatments
Details and patient eligibility
About
This study will evaluate the effects of TT301 on cytokine levels in healthy male volunteers participating in an endotoxin challenge.
Full 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.
Enrollment
Sex
Ages
Volunteers
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
Trial design
Primary purpose
Allocation
Interventional model
Masking
18 participants in 2 patient groups, including a placebo group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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