Back to resultsA Safety/Tolerability and Pharmakokinetic Study of Sargramostim Administrated in the Gingiva
Primary Purpose
Periodontitis
Status
Completed
Phase
Phase 1
Locations
Sweden
Study Type
Interventional
Intervention
sargramostim
Sponsored by
About this trial
This is an interventional treatment trial for Periodontitis
Eligibility Criteria
Inclusion Criteria:
- Healthy individuals (male or female) referred to Dept of Oral & Maxillofacial surgery to have a lower wisdom tooth surgically extracted
- ≥ 20 and ≤ 40 years of age
- Analysis results of blood status within normal reference ranges
- Ability to attend the scheduled visits for evaluation procedures
- Women with child-bearing potential: use of an adequate method of contraception to avoid pregnancy throughout the study
- Signed informed consent
Exclusion Criteria:
- Any significant disease (acute or chronic) or any medication with concomitant oral manifestations that in the opinion of the investigator would interfere with safety evaluation of Leukine.
- An active osseous infection or periodontal infection, any active mucosal lesions or a history of acute necrotizing ulcerative gingivitis.
- Current use of anti-coagulant therapy or within 10 days from baseline
- Current use of immunomodulating medication
- Current use of corticosteroids (Amendment 1: topical use permitted).
- Current use of lithium.
- Use of tobacco products or nicotine replacement therapy
- Alcohol or drug abuse
- HIV or hepatitis infection
- Pregnancy or lactation
- Participation in another clinical study on medicinal products at the time of inclusion
- Lack of suitability for participation in the trial, for any reason, as judged by the Investigator.
Sites / Locations
- Dept of Oral & Maxillofacial Surgery
Outcomes
Primary Outcome Measures
To establish the safety profile of three escalating doses of Leukine when given as single intragingival injections on separate days
Secondary Outcome Measures
To perform a pharmacokinetic evaluation after administration of three escalating doses of Leukine into the gingival tissue as single doses on separate days
Full Information
NCT ID
NCT00689143
First Posted
May 29, 2008
Last Updated
October 28, 2008
Sponsor
Innoventus Project AB
Collaborators
Uppsala University
1. Study Identification
Unique Protocol Identification Number
NCT00689143
Brief Title
A Safety/Tolerability and Pharmakokinetic Study of Sargramostim Administrated in the Gingiva
Official Title
A Phase I, Open-Label, Single Center, Safety/Tolerability and Pharmacokinetic Study of Leukine® Administrated in the Gingiva as Three Single Doses on Separate Days
Study Type
Interventional
2. Study Status
Record Verification Date
October 2008
Overall Recruitment Status
Completed
Study Start Date
August 2008 (undefined)
Primary Completion Date
October 2008 (Actual)
Study Completion Date
October 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Innoventus Project AB
Collaborators
Uppsala University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This exploratory study is the first study in a clinical program where the overall objective is to develop a novel pharmaceutical therapy comprising local administration of GM-CSF for the treatment of periodontitis. The project hypothesis is based on GM-CSF's antibacterial and putative bone regeneration properties. Periodontitis is the major cause of tooth loss in people over 35 years of age. An effective pharmacological treatment is today lacking and the actual therapy would represent a new treatment option for the large patient group suffering from the disease.
Detailed Description
It is suggested that local administration of GM-CSF in the gingival tissue next to the periodontal destruction may reduce the infectious condition by an antibacterial effect via stimulation of neutrophil phagocytosis of bacteria, enhanced functional activities of monocytes and granulocytes, as well as stimulation of bone tissue recalcification.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
sargramostim
Other Intervention Name(s)
GM-CSF, Leukine
Primary Outcome Measure Information:
Title
To establish the safety profile of three escalating doses of Leukine when given as single intragingival injections on separate days
Secondary Outcome Measure Information:
Title
To perform a pharmacokinetic evaluation after administration of three escalating doses of Leukine into the gingival tissue as single doses on separate days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Healthy individuals (male or female) referred to Dept of Oral & Maxillofacial surgery to have a lower wisdom tooth surgically extracted
≥ 20 and ≤ 40 years of age
Analysis results of blood status within normal reference ranges
Ability to attend the scheduled visits for evaluation procedures
Women with child-bearing potential: use of an adequate method of contraception to avoid pregnancy throughout the study
Signed informed consent
Exclusion Criteria:
Any significant disease (acute or chronic) or any medication with concomitant oral manifestations that in the opinion of the investigator would interfere with safety evaluation of Leukine.
An active osseous infection or periodontal infection, any active mucosal lesions or a history of acute necrotizing ulcerative gingivitis.
Current use of anti-coagulant therapy or within 10 days from baseline
Current use of immunomodulating medication
Current use of corticosteroids (Amendment 1: topical use permitted).
Current use of lithium.
Use of tobacco products or nicotine replacement therapy
Alcohol or drug abuse
HIV or hepatitis infection
Pregnancy or lactation
Participation in another clinical study on medicinal products at the time of inclusion
Lack of suitability for participation in the trial, for any reason, as judged by the Investigator.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jan Hirsch, Prof.
Organizational Affiliation
Dept of Oral & Maxillofacial Surgery, Uppsala University Hospital, Sweden
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dept of Oral & Maxillofacial Surgery
City
Uppsala
ZIP/Postal Code
SE-751 85
Country
Sweden
12. IPD Sharing Statement
Learn more about this trial
A Safety/Tolerability and Pharmakokinetic Study of Sargramostim Administrated in the Gingiva
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