Completed

A Phase 1, Single Center, Biomarker Study in Healthy Subjects Receiving Single Doses of CAT-1004

What is being tested

CAT-1004

+ Salsalate + DHA

+ Placebo

Drug

Who is being recruted

From 18 to 55 Years

+4 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Basic Science Study

Placebo-ControlledPhase 1

Interventional

Study Start: August 2012

See protocol details

Summary

Principal SponsorCatabasis Pharmaceuticals

Last updated: October 30, 2012

Sourced from a government-validated database.Claim as a partner

Study start date: August 1, 2012

Actual date on which the first participant was enrolled.

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

NCT01670773

Principal SponsorCatabasis Pharmaceuticals

Last updated: October 30, 2012

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

9 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Basic Science Study

Basic science studies help researchers understand how the body works or how a disease develops. They don't test treatments, but they build the foundation for future therapies.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 55 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

2 inclusion criteria required to participate

BMI between 18 and 30 kg/m2 inclusive

Good health as determined by medical history, vital signs, EGC, physical exam and clinical lab results

2 exclusion criteria prevent from participating

Use of prescription drugs, nonprescription drugs, herbals and dietary supplements within 7 days prior to randomization

Viral or bacterial infection within 21 days prior to randomization

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

3 intervention groups are designated in this study

33.333% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental

Single dose #1

Group II

Active Comparator

Single dose #2

Group III

Placebo

Single Dose #3

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

ProMedica

Brighton, United StatesOpen ProMedica in Google Maps

CompletedOne Study Center