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

NCT00689143 | Completed Phase 1

• 1 other identifier: IPPIS-0604
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Periodontitis

Outcome Measures

Primary Outcomes (1)

• To establish the safety profile of three escalating doses of Leukine when given as single intragingival injections on separate days

Secondary Outcomes (1)

• To perform a pharmacokinetic evaluation after administration of three escalating doses of Leukine into the gingival tissue as single doses on separate days

Interventions

sargramostim DRUG

Also known as: GM-CSF, Leukine

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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
• Lack of suitability for participation in the trial, for any reason, as judged by the Investigator.

Sponsors & Collaborators

• Innoventus Project AB: lead
• Uppsala University: collaborator

Study Sites (1)

Dept of Oral & Maxillofacial Surgery

Uppsala, SE-751 85, Sweden

Location

MeSH Terms

Conditions

Periodontitis

Interventions

sargramostim; Granulocyte-Macrophage Colony-Stimulating Factor

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Officials

• Jan Hirsch, Prof.

  Dept of Oral & Maxillofacial Surgery, Uppsala University Hospital, Sweden

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: May 29, 2008
• First Posted: June 3, 2008
• Study Start: August 1, 2008
• Primary Completion: October 1, 2008
• Study Completion: October 1, 2008
• Last Updated: October 29, 2008

Record last verified: 2008-10

Locations

SE (1)