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NCT01440166 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study of Healthy, sponsored by Catabasis Pharmaceuticals.

Completed
Registry status
Phase 1
Development phase
52
Enrollment target
1
Study location

NCT01440166: Completed Phase 1 study of Healthy, sponsored by Catabasis Pharmaceuticals.

NCT01440166 is a Phase 1 study of Healthy that has completed, run by Catabasis Pharmaceuticals. The registered enrollment target is 52 participants, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (92% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01440166, a Phase 1 study of Healthy, has completed, sponsored by Catabasis Pharmaceuticals.

COMPLETED
Registry status
Phase 1
Development phase
52 participants
Enrollment target
1
Study location

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.

Primary Outcome

Safety Endpoints: Laboratory evaluations including hematology, chemistry, coagulation and urinalysis, physical examinations, AEs, serious AEs (SAEs), ECGs, and vital signs.

Conditions Studied

Interventions

  • OTHER Placebo
  • DRUG Drug

Study Locations (1)

Nebraska

  • Celerion Clinical Research Unit - Lincoln

Trial Details

FieldValue
Enrollment Target 52 participants
Start Date 2011-09
Est. Completion 2012-01
Phase Phase 1
Catabasis Pharmaceuticals

12 total trials

What the finished NCT01440166 record still lists

NCT01440166 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 52 participants, a relatively small participant target, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (92% lower).

The record links to 1 condition, with Healthy appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT01440166 reports a single indexed study location in Nebraska.

Frequently Asked Questions

What is clinical trial NCT01440166 about?

NCT01440166 is a clinical study titled "Safety, Tolerability, and Pharmacokinetic Study of CAT-1004 in Healthy Adult Volunteers". * 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...

What is the current status of trial NCT01440166?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 52 participants. The study started on 2011-09. Estimated completion is 2012-01.

What conditions does trial NCT01440166 study?

This clinical trial studies the following conditions: Healthy.

What interventions are being tested in trial NCT01440166?

The interventions under investigation include: Placebo (OTHER), Drug (DRUG).

Who is sponsoring clinical trial NCT01440166?

This trial is sponsored by Catabasis Pharmaceuticals, which has 12 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01440166 being conducted?

This trial has 1 study location across Nebraska. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Healthy

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT01440166's enrollment target sits among peer trials

52 441st of 1090 higher than 646 of 1,090 other Healthy trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Healthy trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01440166, the US trial registry maintained by the National Library of Medicine. NCT01440166 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.