Overview

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Withdrawn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