A Study of CAT-1004 Biomarkers in Healthy Subjects

October 29, 2012 updated by: Catabasis Pharmaceuticals

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

9

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Brighton, Massachusetts, United States, 02135
        • ProMedica

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: CAT-1004 Dose #1
Single dose #1
Drug: CAT-1004
ACTIVE_COMPARATOR: Salsalate + DHA
Single dose #2
Drug: Salsalate + DHA
PLACEBO_COMPARATOR: Placebo
Single Dose #3
Drug: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Pre/post each of 3 Single doses

Other Outcome Measures

Outcome Measure
Time Frame
Other biomarkers including select cytokines and RNA gene expression may also be assessed
Time Frame: Pre/post each of 3 Single doses
Pre/post each of 3 Single doses

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Catabasis Pharmaceuticals

Investigators

  • Study Director: Joanne Donovan, MD, PhD, Catabasis

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2012

Primary Completion (ACTUAL)

October 1, 2012

Study Completion (ACTUAL)

October 1, 2012

Study Registration Dates

First Submitted

August 16, 2012

First Submitted That Met QC Criteria

August 17, 2012

First Posted (ESTIMATE)

August 22, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

October 30, 2012

Last Update Submitted That Met QC Criteria

October 29, 2012

Last Verified

October 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CAT-1004-103

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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