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NCT00628433 · ClinicalTrials.gov registry record · Phase 1

Safety and Pharmacokinetics Study of HE3286 in Patients With Active, Mild-to-Moderate Ulcerative Colitis

A Phase 1 study of Ulcerative Colitis, sponsored by Harbor Therapeutics.

Completed
Registry status
Phase 1
Development phase
27
Enrollment target
10
Study locations

NCT00628433: Completed Phase 1 study of Ulcerative Colitis, sponsored by Harbor Therapeutics.

NCT00628433 is a Phase 1 study of Ulcerative Colitis that has completed, run by Harbor Therapeutics. The registered enrollment target is 27 participants, below the 2,057-participant average among 122 other Ulcerative Colitis trials with a reported enrollment target (99% lower). The trial reports 10 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00628433, a Phase 1 study of Ulcerative Colitis, has completed, sponsored by Harbor Therapeutics.

COMPLETED
Registry status
Phase 1
Development phase
27 participants
Enrollment target
10
Study locations

Study Summary

The purpose of this pilot, exploratory study is to evaluate the safety, tolerance, pharmacokinetics and potential activity of an investigational agent, HE3286, when administered orally, daily for 28 days to patients with mild-to-moderate ulcerative colitis.

Conditions Studied

Interventions

  • DRUG Placebo
  • DRUG HE3286

Study Locations (10)

California

  • - Anaheim
  • - Fresno
  • - La Jolla

Colorado

  • - Denver
  • - Denver

Arizona

  • - Tucson

Florida

  • - Winter Park

Georgia

  • - Atlanta

Kentucky

  • - Louisville

Texas

  • - El Paso

Trial Details

FieldValue
Enrollment Target 27 participants
Start Date 2008-02
Est. Completion 2009-05
Phase Phase 1
Harbor Therapeutics

7 total trials

What the finished NCT00628433 record still lists

NCT00628433 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 27 participants, a relatively small participant target, below the 2,057-participant average among 122 other Ulcerative Colitis trials with a reported enrollment target (99% lower).

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

NCT00628433 lists 10 locations in 7 states (California, Colorado, Arizona).

Frequently Asked Questions

What is clinical trial NCT00628433 about?

NCT00628433 is a clinical study titled "Safety and Pharmacokinetics Study of HE3286 in Patients With Active, Mild-to-Moderate Ulcerative Colitis". The purpose of this pilot, exploratory study is to evaluate the safety, tolerance, pharmacokinetics and potential activity of an investigational agent, HE3286, when administered orally, daily for 28 days to patients with mild-to-moderate ulcerative colitis.

What is the current status of trial NCT00628433?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 27 participants. The study started on 2008-02. Estimated completion is 2009-05.

What conditions does trial NCT00628433 study?

This clinical trial studies the following conditions: Ulcerative Colitis.

What interventions are being tested in trial NCT00628433?

The interventions under investigation include: Placebo (DRUG), HE3286 (DRUG).

Who is sponsoring clinical trial NCT00628433?

This trial is sponsored by Harbor Therapeutics, which has 7 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00628433 being conducted?

This trial has 10 study locations across Arizona, California, Colorado, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Ulcerative Colitis

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 NCT00628433's enrollment target sits among peer trials

27 106th of 122 higher than 17 of 122 other Ulcerative Colitis trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Ulcerative Colitis 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 NCT00628433, the US trial registry maintained by the National Library of Medicine. NCT00628433 (small enrollment · multi site footprint · completed) retrieved and formatted by PlainTrial, see methodology.