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A Study of CAT-1004 Biomarkers in Healthy Subjects

NCT ID: NCT01670773

Last Updated: 2012-10-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-08-31

Study Completion Date

2012-10-31

Brief Summary

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

Detailed Description

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Conditions

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Assessment of Mechanistic Blood Biomarkers in Healthy Humans

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Study Groups

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CAT-1004 Dose #1

Single dose #1

Group Type EXPERIMENTAL

CAT-1004

Intervention Type DRUG

Salsalate + DHA

Single dose #2

Group Type ACTIVE_COMPARATOR

Salsalate + DHA

Intervention Type DRUG

Placebo

Single Dose #3

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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CAT-1004

Intervention Type DRUG

Salsalate + DHA

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Catabasis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Joanne Donovan, MD, PhD

Role: STUDY_DIRECTOR

Catabasis

Locations

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ProMedica

Brighton, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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CAT-1004-103

Identifier Type: -

Identifier Source: org_study_id