NCT01440166

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

A Single Center, Randomized, Double-Blind, Placebo-Controlled, Ascending Dose, Safety, Tolerability, and Pharmacokinetic Study of CAT-1004 in Healthy Adult Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 52 (actual)
• Sponsor: Catabasis Pharmaceuticals · Industry
• Sex: All
• Age: 19 Years – 55 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2011-09-01
• Primary completion: 2012-01-01
• Completion: 2012-01-01
• First posted: 2011-09-26
• Last updated: 2012-02-06

Locations

1 site across 1 country: United States