A Study of CAT-1004 Biomarkers in Healthy Subjects

Catabasis Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Assessment of Mechanistic Blood Biomarkers in Healthy Humans

Treatments: Drug: Salsalate + DHA; Drug: Placebo; Drug: CAT-1004

Study type: Interventional

Funder types: Industry

Identifiers

NCT01670773

CAT-1004-103

Details and patient eligibility

About

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

Enrollment: 9 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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9 participants in 3 patient groups, including a placebo group

CAT-1004 Dose #1

Experimental group

Description:

Single dose #1

Treatment:

Drug: CAT-1004

Salsalate + DHA

Active Comparator group

Description:

Single dose #2

Treatment:

Drug: Salsalate + DHA

Placebo

Placebo Comparator group

Description:

Single Dose #3

Treatment:

Drug: Placebo