Clinical trial NCT00743769: A Phase 1 Safety Study of the Intravenous Administration of Thymosin Beta in Healthy Volunteers
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 and Its Pharmacokinetics After Single and Multiple Doses in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Myocardial Infarction
Myocardial Ischemia
Keywords: Myocardial Infarction
Myocardial Ischemia
Myocardial Diseases
Infarction
Lead sponsor: RegeneRx Biopharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2008-08-29
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: The cardio-protective effect of Tβ4 treatment was shown in a permanently ligated mouse model.The authors demonstrated that systemic Tβ4 treatment (intraperitoneal, intracardiac, or i.p. plus intracardiac) every third day enhanced early myocyte survival and significantly improved cardiac function. Several weeks after the heart attack, it was evident that mice treated with Tβ4 had less muscle damage and stronger hearts compared with mice treated with placebo. Specifically, Tβ4 treatment significantly improved fractional shortening by about 60% and ejection fraction by about 100% and myocardial salvage by about 53% when compared with controls.

Eligibility criteria: Inclusion Criteria:

* In good health with no underlying medical condition that, according to the Investigator, would place a subject at risk
* Having given written informed consent

Exclusion Criteria:

* Evidence of any malignancy
* Use of any tobacco product within 7 years of study entry
* Pregnant or lactating women
* History of drug abuse
* Clinically significant abnormal screening ECG
* Abnormal vital signs
* Use of systemic steroidal therapy), immunotherapy, cytotoxic, chemotherapy or any investigational drug or device within 30 days of study entry. Topical steroids are allowed
* Women, 40 years of age and above, who have not had a mammography within one year of study entry
* Men and women, 50 years of age and above, who have not had a sigmoidoscopy within 5 years and colonoscopy within 10 years of study entry

Primary outcomes:
measure: Evaluate safety parameters in single-ascending doses of Tβ4(42 mg, 140 mg, 420 mg or 1,260 mg per dose) administered intravenously to healthy volunteers, such as ECG, vital signs,lab tests, etc.
timeFrame: one day
Secondary outcomes:
measure: Evaluate pharmacokinetic parameters in single-ascending doses of Tβ4(42 mg, 140 mg, 420 mg or 1,260 mg per dose) administered intravenously to healthy volunteers
timeFrame: one day
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: Healthcare Discoveries LLC
state: Texas
Study officials:
affiliation: Healthcare Discoveries LLC
name: Dennis Ruff, MD
role: PRINCIPAL_INVESTIGATOR
References: