A Study of CAT-1004 Biomarkers in Healthy Subjects

Phase 1

Completed

• Conditions: Assessment of Mechanistic Blood Biomarkers in Healthy Humans
• Interventions: Drug: Salsalate + DHA; Drug: Placebo; Drug: CAT-1004

• Registration Number: NCT01670773
• Lead Sponsor: Catabasis Pharmaceuticals

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2012-08
• Study First Submitted: 2012-08-16
• Study First Submitted QC: 2012-08-17
• Study First Posted: 2012-08-22
• Status Verified: 2012-10
• Primary Completion: 2012-10
• Study Completion: 2012-10
• Last Update Submitted: 2012-10-29
• Last Update Posted: 2012-10-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 9

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Salsalate + DHA	Salsalate + DHA	Single dose #2
Placebo	Placebo	Single Dose #3
CAT-1004 Dose #1	CAT-1004	Single dose #1

Primary Outcome Measures

Name	Time	Method
Change in nuclear factor kappa-light-chain-enhancer of activated B cells (NF-kB) activity p65 following ex vivo lipopolysaccharide stimulation	Pre/post each of 3 Single doses

Trial Locations

Locations (1)

ProMedica; 🇺🇸 Brighton, Massachusetts, United States