A Phase 1 Safety Study of the Intravenous Administration of Thymosin Beta in Healthy Volunteers

NCT00743769 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2017-04-17

No results posted yet for this study

Summary

The purpose of this study is to determine whether the intravenous administration of single- and multiple-ascending doses of Thymosin Beta 4 is safe and tolerable in healthy volunteers.

Conditions

Interventions

DRUG

thymosin beta 4

Single bolus injections of ascending doses of 42 mg, 140 mg, 420 mg or 1,260 QD of thymosin beta 4

OTHER

Placebo

Single bolus injections of ascending doses of 0.00 mg QD of thymosin beta 4

Sponsors & Collaborators

  • RegeneRx Biopharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Dennis Ruff, MD · Healthcare Discoveries LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
79 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-04-30
Primary Completion
2017-01-01
Completion
2017-01-01

Countries

  • United States

Study Locations

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Entities

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 NCT00743769 on ClinicalTrials.gov