Phase 1 Study Evaluating the Safety, Pharmacokinetics and Pharmacodynamics of PRTX-100 in Healthy Adult Volunteers

Completed · Phase 1

Conditions studied: Healthy Volunteers

In brief

This study is the second human clinical study with PRTX-100. It is designed to assess the safety of a single intravenous (IV) dose of PRTX-100, as well as, how the drug is eliminated from the blood after dosing. Additionally, this study provides an opportunity to monitor immune system response to PRTX-100.

Key facts

Study ID

NCT00517855

Run by

Protalex, Inc.

People needed

20

Starts

2007-06-01

Expected to finish

2007-09-01

Last updated by the study team

2008-05-06

Who can join

Age: 18 and older, up to 45. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Able to provide written, informed consent
• Subjects in good health as determined by medical history, physical exam, standard safety laboratory tests, electrocardiogram (ECG) and vital signs
• Body Mass Index (BMI) within the range of 18.5-32 kg/m2
• Normotensive, defined as systolic blood pressure less than or equal to 150 mmHg and diastolic blood pressure less than or equal to 90 mmHg

You may not qualify if…

• Positive IgE anti-SpA titer on screening visit
• Male and female subjects unwilling to use acceptable forms of birth control throughout the study (acceptable forms include hormonal contraceptives used for at least 2 months prior to the screening visit, condom plus spermicide, cervical cap plus spermicide, diaphragm plus spermicide, or intrauterine device plus spermicide)
• Pregnant (β-hCG serum pregnancy test positive) or nursing (lactating) female subjects
• Clinically significant history or evidence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, neurological, immunological, or psychiatric disorder(s), as determined by the investigator or designee
• Past medical history of deep venous thrombosis or thromboembolic disease, stroke, myocardial infarction, recurrent fetal loss, or prior diagnosis of Protein C deficiency or of factor V Leyden genotype
• Past history of vasculitis or autoimmune disease
• Clinical signs or symptoms of acute or resolving viral or bacterial infection
• History of atopic dermatitis or asthma
• History of current hepatitis or carriers of hepatitis B and/or hepatitis C (Hepatitis B surface antigen [HbsAg] positive or IgM antibodies to Hepatitis C [anti Hepatitis C IgM]).
• History of AIDS or determined HIV seropositive at screening
• Any disorder that would interfere with the absorption, distribution, metabolism, or excretion of drugs
• Clinically significant abnormalities in screening laboratory tests (hematology, chemistry, urinalysis)
• Positive urine drug test at screening or baseline (e.g., cocaine, amphetamines, barbiturates, opiates, benzodiazepines, etc.)
• Positive blood test for ethanol at screening or baseline
• Use of dietary supplements or prescription (with the exception of hormonal contraceptives), herbal, and over-the-counter medication(s) (with the exception of acetaminophen less than or equal to 1000 mg/day) within the 10 days prior to study Day 1
• Unable to refrain from tobacco or nicotine product use during the period of study confinement
• Donation of blood or plasma within 30 days prior to dosing
• Use of (an) investigational drug(s) within the 30 days or 5 half-lives (whichever is longer) prior to Day 1

Where it is running

• Buffalo Clinical Research Center — Buffalo, New York, United States

Full record on ClinicalTrials.gov

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