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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 20, 2014