A Study of CAT-1004 Biomarkers in Healthy Subjects
A Phase 1, Single Center, Biomarker Study in Healthy Subjects Receiving Single Doses of CAT-1004
1 other identifier
interventional
9
1 country
1
Brief Summary
This study is being conducted to assess mechanistic blood biomarkers of CAT-1004 in healthy humans.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Aug 2012
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
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2012
CompletedFirst Submitted
Initial submission to the registry
August 16, 2012
CompletedFirst Posted
Study publicly available on registry
August 22, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2012
CompletedOctober 30, 2012
October 1, 2012
2 months
August 16, 2012
October 29, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
Change in nuclear factor kappa-light-chain-enhancer of activated B cells (NF-kB) activity p65 following ex vivo lipopolysaccharide stimulation
Pre/post each of 3 Single doses
Other Outcomes (1)
Other biomarkers including select cytokines and RNA gene expression may also be assessed
Pre/post each of 3 Single doses
Study Arms (3)
CAT-1004 Dose #1
EXPERIMENTALSingle dose #1
Salsalate + DHA
ACTIVE COMPARATORSingle dose #2
Placebo
PLACEBO COMPARATORSingle Dose #3
Interventions
Eligibility Criteria
You may qualify if:
- Good health as determined by medical history, vital signs, EGC, physical exam and clinical lab results
- BMI between 18 and 30 kg/m2 inclusive
You may not qualify if:
- Viral or bacterial infection within 21 days prior to randomization
- Use of prescription drugs, nonprescription drugs, herbals and dietary supplements within 7 days prior to randomization
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
ProMedica
Brighton, Massachusetts, 02135, United States
MeSH Terms
Interventions
Study Officials
- STUDY DIRECTOR
Joanne Donovan, MD, PhD
Catabasis
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 16, 2012
First Posted
August 22, 2012
Study Start
August 1, 2012
Primary Completion
October 1, 2012
Study Completion
October 1, 2012
Last Updated
October 30, 2012
Record last verified: 2012-10