A Safety/Tolerability and Pharmakokinetic Study of Sargramostim Administrated in the Gingiva

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Periodontitis

Intervention / Treatment
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* Drug: sargramostim


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: sargramostim|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To establish the safety profile of three escalating doses of Leukine when given as single intragingival injections on separate days |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To perform a pharmacokinetic evaluation after administration of three escalating doses of Leukine into the gingival tissue as single doses on separate days |  |  |