Autoimmune Diseases Clinical Trial
Official title:
A Single and Repeat Dose Pharmacokinetics/ Pharmacodynamics (PK/PD) Study to Characterise theBiomarker Response in Healthy Subjects Treated With the AntiinflammatoryMacrolide Azithromycin
This is a two part protocol (Parts A and B) in healthy volunteers evaluating the
pharmacokinetics/ pharmacodynamics (PK/PD) of azithromycin to investigate the usefulness of
various biomarkers (e.g., Interleukin-10 (IL-10), Granulocyte macrophage colony-stimulating
factor (GM-CSF), mature dendritic cell (MDC), with and without ex vivo lipopolysaccharide
(LPS) stimulation) as markers of macrolide anti-inflammatory activity.
Part A is a randomized, open-label parallel group study evaluating PK/PD of a single
azithromycin dose of 250 or 1000 mg. Data from Part A will be used to assess the dose
resulting in induction/inhibition of various ex vivo biomarkers relative to a 250 mg dose of
azithromycin (the clinical dose used in treatment of neutrophil-induced inflammatory
conditions). This information will guide the range of doses to be studied in a first time in
humans (FTIH) study of a new chemical entity.
Part B is a repeat dose study treating subjects with Azithromycin (250 mg every other day for
3 weeks), the dose approximates that used in the treatment of chronic neutrophil related
inflammatory conditions. This information will provide insight into whether the biomarker
effects change over time on repeat dosing and any potential differences observed between
single and repeat doses.
This is a two part protocol (Parts A and B) in healthy volunteers evaluating the
pharmacokinetics/ pharmacodynamics (PK/PD) of azithromycin to investigate the usefulness of
various biomarkers (e.g., IL-10, GM-CSF, MDC, with and without ex vivo lipopolysaccharide
(LPS) stimulation) as markers of macrolide anti-inflammatory activity.
Part A is a randomized, open-label parallel group study evaluating PK/PD of a single
azithromycin dose of 250 or 1000 mg. Data from Part A will be used to assess the dose
resulting in induction/inhibition of various ex vivo biomarkers relative to a 250 mg dose of
azithromycin (the clinical dose used in treatment of neutrophil-induced inflammatory
conditions). This information will guide the range of doses to be studied in a FTIH study of
a new chemical entity.
Part B is a repeat dose study treating subjects with Azithromycin (250 mg every other day for
3 weeks), the dose approximates that used in the treatment of chronic neutrophil related
inflammatory conditions. This information will provide insight into whether the biomarker
effects change over time on repeat dosing and any potential differences observed between
single and repeat doses.
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