Effects of TT301 on Cytokine Levels Post Endotoxin Challenge

OPKO Health, Inc.18 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Traumatic Brain Injury

Interventions

TT301DRUG

Single iv dose of TT301

PlaceboDRUG

Single iv dose of 0.9% sodium chloride for injection USP

Eligibility

Sex: MALEMin age: 18 YearsMax age: 40 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Duke Clinical Research Unit

Durham, North Carolina, United States

Outcomes

Primary Outcomes

Cytokine levels post LPS challenge

Time frame: Measured up to 12h post-LPS

Data from ClinicalTrials.gov

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