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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Myocardial Infarction, Myocardial Ischemia

Intervention / Treatment
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* Drug: thymosin beta 4
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 79 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 2<br>Thymosin Beta 4 A single bolus injections of ascending doses of 42 mg, 140 mg, 420 mg or 1,260 QD (once a day) | Drug: thymosin beta 4<br>* Single bolus injections of ascending doses of 42 mg, 140 mg, 420 mg or 1,260 QD of thymosin beta 4<br>|
| Placebo Comparator: 1<br>Placebo A single bolus injection of 0.0 mg QD of thymosin beta 4 | Other: Placebo<br>* Single bolus injections of ascending doses of 0.00 mg QD of thymosin beta 4<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  | one day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  | one day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Myocardial Infarction, Myocardial Ischemia, Myocardial Diseases, Infarction