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TB-500

Thymosin Beta-4, TB4, Tβ4

Quick Stats
Studies 6
Trials 21
Completed PHASE2 INTERVENTIONAL NCT00382174

Study of Thymosin Beta 4 in Patients With Pressure Ulcers

View on ClinicalTrials.gov Updated Dec 15, 2025

Brief Summary

The purpose of this study is to evaluate the safety, tolerability and effectiveness of Thymosin Beta 4 administered topically in patients with Pressure Ulcers

Detailed Description

The purpose of this double-blind, placebo-controlled, dose-escalation study is to evaluate the safety, tolerability and effectiveness of Thymosin Beta 4 (Tβ4), administered topically, in patients with Pressure Ulcers (PU). PU is caused by prolonged pressure or rubbing of the body in areas prone to moisture and friction. PU affects primarily elderly, bedridden patients. Tβ4 is a synthetically-produced copy of a naturally-occurring 43 amino acid peptide that has wound healing and anti-inflammatory properties and can up-regulate the expression of laminin-5.

Interventions

Name: Placebo
Type: DRUG
Description: Topical administration of 0.00% thymosin beta 4 qd up to 84 days
Name: Thymosin Beta 4
Type: DRUG
Description: Topical Administration of 0.01, 0.02, and 0.1% thymosin beta 4 gel qd for up to 84 days

Primary Outcomes

Measure: Safety and Tolerability of Thymosin Beta 4 (Tβ4)Applied for up to 84 Days
TimeFrame: Up to 84 days
Description: All Treatment-Emergent Serious Adverse Events (SAEs) and AEs by treatment dose safety population

Trial Information

NCT ID

NCT00382174

Status

Completed

Study Type

INTERVENTIONAL

Phases

PHASE2

Sponsor

RegeneRx Biopharmaceuticals, Inc.

Last Updated

December 15, 2025