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

• Status: Withdrawn
• Trial end date: 2017-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: RegeneRx Biopharmaceuticals, Inc.

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