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
Overview
- Phase
- Phase 1
- Intervention
- thymosin beta 4
- Conditions
- Myocardial Infarction
- Sponsor
- RegeneRx Biopharmaceuticals, Inc.
- Locations
- 1
- Primary Endpoint
- 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.
- Status
- Withdrawn
- Last Updated
- 9 years ago
Overview
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.
Investigators
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
Arms & Interventions
2
Thymosin Beta 4 A single bolus injections of ascending doses of 42 mg, 140 mg, 420 mg or 1,260 QD (once a day)
Intervention: thymosin beta 4
1
Placebo A single bolus injection of 0.0 mg QD of thymosin beta 4
Intervention: Placebo
Outcomes
Primary Outcomes
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.
Time Frame: one day
Secondary Outcomes
- 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)