A Study of CAT-1004 Biomarkers in Healthy Subjects

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Catabasis Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01670773
First received: August 16, 2012
Last updated: October 29, 2012
Last verified: October 2012
  Purpose

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


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Basic Science
Official Title: A Phase 1, Single Center, Biomarker Study in Healthy Subjects Receiving Single Doses of CAT-1004

Resource links provided by NLM:


Further study details as provided by Catabasis Pharmaceuticals:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Other biomarkers including select cytokines and RNA gene expression may also be assessed [ Time Frame: Pre/post each of 3 Single doses ] [ Designated as safety issue: No ]

Enrollment: 9
Study Start Date: August 2012
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01670773

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

No publications provided

Responsible Party: Catabasis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01670773     History of Changes
Other Study ID Numbers: CAT-1004-103
Study First Received: August 16, 2012
Last Updated: October 29, 2012
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on April 17, 2014