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A Study of CAT-1004 Biomarkers in Healthy Subjects

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ClinicalTrials.gov Identifier: NCT01670773
Recruitment Status : Completed
First Posted : August 22, 2012
Last Update Posted : October 30, 2012
Sponsor:
Information provided by (Responsible Party):
Catabasis Pharmaceuticals

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

Condition or disease Intervention/treatment Phase
Assessment of Mechanistic Blood Biomarkers in Healthy Humans Drug: CAT-1004 Drug: Salsalate + DHA Drug: Placebo Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Official Title: A Phase 1, Single Center, Biomarker Study in Healthy Subjects Receiving Single Doses of CAT-1004
Study Start Date : August 2012
Actual Primary Completion Date : October 2012
Actual Study Completion Date : October 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Salsalate
U.S. FDA Resources

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



Primary Outcome Measures :
  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 Outcome Measures:
  1. Other biomarkers including select cytokines and RNA gene expression may also be assessed [ Time Frame: Pre/post each of 3 Single doses ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01670773


Locations
United States, Massachusetts
ProMedica
Brighton, Massachusetts, United States, 02135
Sponsors and Collaborators
Catabasis Pharmaceuticals
Investigators
Study Director: Joanne Donovan, MD, PhD Catabasis

Responsible Party: Catabasis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01670773     History of Changes
Other Study ID Numbers: CAT-1004-103
First Posted: August 22, 2012    Key Record Dates
Last Update Posted: October 30, 2012
Last Verified: October 2012

Additional relevant MeSH terms:
Salicylsalicylic acid
Sodium Salicylate
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action