Official Title: A Randomized, Double-Blind, Placebo-Controlled, Dose-Response, Phase 1 Study of the Safety and Tolerability of the Intravenous Administration of Thymosin Beta 4 (Tβ4) and its Pharmacokinetics after Single (Phase 1A) and Multiple (Phase 1B) Doses in Healthy Volunteers.

Purpose: The purpose of this study is to determine the safety of i.v. administration of a Thymosin Beta 4 (Tβ4) as single and multiple doses.

Study Type: Phase 1A & Phase 1B

Study Design: Randomized, double-blind, placebo-controlled, dose response

Locations: U.S., 1 site

Expected Total Enrollment: 40

Targeted Study Completion: Q3 2008 and Q4 2008, respectively

Study Start: Recruiting

ClinicalTrials.gov ID: Not assigned yet

Objectives:

• To assess the safety and tolerability of Thymosin Beta 4 (Tβ4) administered by intravenous (i.v.) injection as a single and multiple doses to healthy volunteers.

• To assess pharmacokinetics parameters after single and multiple doses of Tβ4 administered by i.v. application to healthy volunteers.

• To assess the presence or absence of antibodies to Tβ4 after single and multiple doses of Tβ4 administered by i.v. application to healthy volunteers.