Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Azithromycin- every other day for 3 weeks · 1 trial · 1 indication
Parameters from PK/PD modelling of the time course of concentrations and inhibition/induction of relevant ex vivo biomarkers (e.g., MDC, GM-CSF and IL-10 with varying levels of LPS stimulation) including the IC50 along with distribution parameters (e.g., kin and kout).
Maximum inhibition/induction of relevant ex vivo biomarkers (e.g., MDC, GM-CSF and IL-10) and timing of this maximum
| Arm | Type | Description |
|---|---|---|
| Part A - randomized, open-label parallel group | ACTIVE_COMPARATOR | 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 - repeat dose group | ACTIVE_COMPARATOR | 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. |
| Name | Type | Description |
|---|---|---|
| Azithromycin - 250 mg | DRUG | Part A - A single azithromycin dose of 250 mg. |
| Azithromycin - 1000 mg | DRUG | Part A - A single azithromycin dose of 1000 mg. |
| Azithromycin - 250 mg every other day for 3 weeks | DRUG | Part B - 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. |
Inclusion Criteria: * Male or female between 18 and 65 years of age inclusive * Non-childbearing potential defined as pre-menopausal females with a documented tubal ligation or hysterectomy * Child-bearing potential and agrees to use one of the contraception methods * Body weight ≥ 50 kg and body m...