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
1 other identifier
interventional
18
1 country
1
Brief Summary
This study will evaluate the effects of TT301 on cytokine levels in healthy male volunteers participating in an endotoxin challenge.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started May 2011
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2011
CompletedFirst Submitted
Initial submission to the registry
May 13, 2011
CompletedFirst Posted
Study publicly available on registry
May 20, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2011
CompletedJune 6, 2013
June 1, 2013
1 month
May 13, 2011
June 4, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
Cytokine levels post LPS challenge
Measured up to 12h post-LPS
Study Arms (2)
TT301
EXPERIMENTALInvestigational drug TT301
Placebo
PLACEBO COMPARATORNormal saline
Interventions
Eligibility Criteria
You may qualify if:
- Male
- to 40 years, inclusive
- kg, inclusive
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Duke Clinical Research Unit
Durham, North Carolina, 27710, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Laura Agensky, BSc, MBA
Transition Therapeutics Inc. / Waratah Pharmaceuticals Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 13, 2011
First Posted
May 20, 2011
Study Start
May 1, 2011
Primary Completion
June 1, 2011
Study Completion
June 1, 2011
Last Updated
June 6, 2013
Record last verified: 2013-06