Effects of TT301 on Cytokine Levels Post Endotoxin Challenge

A Phase 1 Double-blind, Randomized, Placebo-controlled Study Evaluating the Effects of a Single Intravenous Dose of TT301 on LPS-induced Changes in Blood Cytokine Levels in Healthy Male Volunteers

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01357421

Enrollment

Registered

2011-05-20

Start date

2011-05-31

Completion date

2011-06-30

Last updated

2013-06-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Traumatic Brain Injury

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.

Interventions

DRUGTT301

Single iv dose of TT301

DRUGPlacebo

Single iv dose of 0.9% sodium chloride for injection USP

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

MALE

Age

18 Years to 40 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Cytokine levels post LPS challenge	Measured up to 12h post-LPS

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026