Current partner codePEPTIDESDE
NCT00743769·Phase 1·INTERVENTIONAL

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

Status

Withdrawn

Phase

Phase 1

Enrollment

0

Locations

1

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

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.

Full 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.

Interventions

Treatment arms and agents.

DRUG

thymosin beta 4

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

OTHER

Placebo

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

Timeline

From registration to results.

  1. First posted

    Aug 29, 2008

  2. Study start

    Apr 2008

  3. Primary completion

    Jan 1, 2017

  4. Study completion

    Jan 1, 2017

  5. Results posted

    Not reported

  6. Registry updated

    Apr 17, 2017

Outcomes

What the study measures.

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

Time frame · one day

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
79 Years
Sex
ALL
Healthy volunteers
Yes

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

Study locations

1 registered sites.

United States. Showing up to 24 locations stored in the fast local snapshot.

Healthcare Discoveries LLC

San Antonio, Texas, United States

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

Related trials

More studies on Thymosin Beta-4.

Related PeptideStat pages

Put the record in context.

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