Status:
COMPLETED
A Safety/Tolerability and Pharmakokinetic Study of Sargramostim Administrated in the Gingiva
Lead Sponsor:
Innoventus Project AB
Collaborating Sponsors:
Uppsala University
Conditions:
Periodontitis
Eligibility:
All Genders
20-40 years
Phase:
PHASE1
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 ...
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 neutrop...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2008
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT00689143
Start Date
August 1 2008
End Date
October 1 2008
Last Update
October 29 2008
Active Locations (1)
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1
Dept of Oral & Maxillofacial Surgery
Uppsala, Sweden, SE-751 85