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Safety, Tolerability, and Pharmacokinetic Study of CAT-1004 in Healthy Adult Volunteers

NCT01440166 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2012-02-06

No results posted yet for this study

Summary

* To evaluate the safety and tolerability of escalating single doses of CAT-1004 relative to placebo in healthy adult volunteers.
* To evaluate the pharmacokinetics (PK) of escalating single doses of CAT-1004 in healthy adult volunteers.
* To evaluate the effect of a high-fat meal on single doses of CAT-1004 in healthy adult volunteers.

Conditions

  • Healthy

Interventions

DRUG

Drug

Single dose oral administration of CAT1004 or placebo-6 to 8 subjects will be treated with CAT-1004 per cohort.

OTHER

Placebo

Single dose oral administration of CAT1004 or placebo- 2 subjects treated with placebo per cohort.

Sponsors & Collaborators

  • Catabasis Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Scott Rasmussen, MD · Celerion

Study Design

Allocation
RANDOMIZED
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-09-30
Primary Completion
2012-01-31
Completion
2012-01-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01440166 on ClinicalTrials.gov