Effects of TT301 on Cytokine Levels Post Endotoxin Challenge

NCT ID: NCT01357421

Last Updated: 2013-06-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-05-31
• Study Completion Date: 2011-06-30

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.

Conditions

Traumatic Brain Injury

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

TT301

Investigational drug TT301

Group Type: EXPERIMENTAL

TT301

Intervention Type: DRUG

Single iv dose of TT301

Placebo

Normal saline

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Single iv dose of 0.9% sodium chloride for injection USP

Interventions

TT301

Single iv dose of TT301

Intervention Type: DRUG

Placebo

Single iv dose of 0.9% sodium chloride for injection USP

Intervention Type: DRUG

Other Intervention Names

TT301 iv; 0.9% sodium chloride for injection USP

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

OPKO Health, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Laura Agensky, BSc, MBA

Role: STUDY_DIRECTOR

Transition Therapeutics Inc. / Waratah Pharmaceuticals Inc.

Locations

Duke Clinical Research Unit

Durham, North Carolina, United States

Countries

United States

Other Identifiers

NMX-103

Identifier Type: -

Identifier Source: org_study_id