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

NCT00743769 | Withdrawn Phase 1

• 1 other identifier: RGN-MI-101
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Myocardial Infarction; Myocardial Ischemia

Keywords

Myocardial Infarction; Myocardial Ischemia; Myocardial Diseases; Infarction

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Study Arms (2)

2

ACTIVE COMPARATOR

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

1

PLACEBO COMPARATOR

Placebo A single bolus injection of 0.0 mg QD of thymosin beta 4

Other: Placebo

Interventions

thymosin beta 4 DRUG

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

2

Placebo OTHER

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

1

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• RegeneRx Biopharmaceuticals, Inc.: lead

Study Sites (1)

Healthcare Discoveries LLC

San Antonio, Texas, 78209, United States

Location

MeSH Terms

Conditions

Myocardial Infarction; Myocardial Ischemia; Cardiomyopathies; Infarction

Interventions

thymosin beta(4)

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Officials

• Dennis Ruff, MD

  Healthcare Discoveries LLC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 27, 2008
• First Posted: August 29, 2008
• Study Start: April 1, 2008
• Primary Completion: January 1, 2017
• Study Completion: January 1, 2017
• Last Updated: April 17, 2017

Record last verified: 2017-04

Locations

US (1)