NCT00517855

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at P25-P50 for phase_1 healthy-volunteers

Timeline
Completed

Started Jun 2007

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2007

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 15, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 17, 2007

Completed
15 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2007

Completed
Last Updated

May 6, 2008

Status Verified

May 1, 2008

Enrollment Period

3 months

First QC Date

August 15, 2007

Last Update Submit

May 1, 2008

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (2)

  • Pharmacokinetics

    Various timepoints over 14 days

  • Safety (assessed by adverse events, clinical lab tests, vital signs, ECG, physical exam)

    Various timepoints over 60 days

Secondary Outcomes (2)

  • Immunogenicity

    Various timepoints over 60days

  • Pharmacodynamic markers of drug effect

    Various timepoints over 60 days

Interventions

PRTX-100 (Staphylococcal protein A)BIOLOGICAL

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

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
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Buffalo Clinical Research Center

Buffalo, New York, 14202, United States

Location

MeSH Terms

Interventions

Staphylococcal Protein A

Intervention Hierarchy (Ancestors)

Antigens, BacterialBacterial ProteinsProteinsAmino Acids, Peptides, and ProteinsAntigensBiological Factors

Study Officials

  • Charles H Ballow, PharmD

    Buffalo Clinical Research Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 15, 2007

First Posted

August 17, 2007

Study Start

June 1, 2007

Primary Completion

September 1, 2007

Study Completion

September 1, 2007

Last Updated

May 6, 2008

Record last verified: 2008-05

Locations

US(1)