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OpenTrials
Completed

NCT Number: NCT01670773

A Study of CAT-1004 Biomarkers in Healthy Subjects

This study is being conducted to assess mechanistic blood biomarkers of CAT-1004 in healthy humans.

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Key information

Conditions

Assessment of Mechanistic Blood Biomarkers in Healthy Humans

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

ProMedica

Brighton, Massachusetts, 02135, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Good health as determined by medical history, vital signs, EGC, physical exam and clinical lab results
  • BMI between 18 and 30 kg/m2 inclusive

Exclusion criteria

  • 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

Treatment and study plan

CAT-1004

Drug

Salsalate + DHA

Drug

Placebo

Drug

Primary outcomes

  1. Change in nuclear factor kappa-light-chain-enhancer of activated B cells (NF-kB) activity p65 following ex vivo lipopolysaccharide stimulation

    Time frame: Pre/post each of 3 Single doses

Other outcomes

  1. Other biomarkers including select cytokines and RNA gene expression may also be assessed

    Time frame: Pre/post each of 3 Single doses

Sponsors and collaborators

Lead sponsor

Catabasis Pharmaceuticals

Industry

Registry information

Official study title

A Phase 1, Single Center, Biomarker Study in Healthy Subjects Receiving Single Doses of CAT-1004

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Aug 22, 2012
Registry last updated
Oct 30, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.