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

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.

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.