Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
AZD9567 Monohydrat · 1 trial · 6 indications
Safety and tolerability variables included AEs, vital signs (blood pressure and pulse), ECGs (12-lead ECGs, safety ECGs and telemetry), clinical laboratory safety evaluations (haematology, clinical chemistry \[including osteocalcin\], coagulation, urinalysis \[including 24 hour urine cortisol per day {tU-cortisol}\]) and physical examinations. Note: No clinically relevant findings were noted in clinical laboratory results and vial signs assessments. Hence, none of the laboratory or vital signs findings were reported as AEs.
To assess the Cmax of AZD9567 oral suspension following 8 single ascending doses (2, 10, 20, 40, 80, 100, 125 and 155 mg) in Cohorts 1 to 8 in the fasted state. Cmax was taken directly from the individual concentration-time curve.
To assess the tmax of AZD9567 oral suspension following 8 single ascending doses (2, 10, 20, 40, 80, 100, 125 and 155 mg) in Cohorts 1 to 8 in the fasted state. tmax was taken directly from the individual concentration-time curve.
To assess t½λz of AZD9567 oral suspension following 8 single ascending doses (2, 10, 20, 40, 80, 100, 125 and 155 mg) in Cohorts 1 to 8 in the fasted state. t½λz was estimated as (ln2)/λz.
To assess AUC(0-last) of AZD9567 oral suspension following 8 single ascending doses (2, 10, 20, 40, 80, 100, 125 and 155 mg) in Cohorts 1 to 8 in the fasted state.
To assess AUC of AZD9567 oral suspension following 8 single ascending doses (2, 10, 20, 40, 80, 100, 125 and 155 mg) in Cohorts 1 to 8 in the fasted state. AUC was estimated by AUC(0-last) + Clast/λz. Clast - the last observed quantifiable concentration.
| Arm | Type | Description |
|---|---|---|
| AZD9567 oral suspension | EXPERIMENTAL | In Part A: up to 8 cohorts with single ascending doses (starting at 2 mg up to 155 mg). In Part B: one cohort with a single dose |
| Placebo | PLACEBO_COMPARATOR | Subjects randomized to placebo in the first 8 cohorts will receive the same dose volume of oral suspension as subjects on AZD9567 and subjects randomized to placebo in cohort 9(prednisolone cohort) will receive the same number of capsules as subjects on prednisolone. |
| Prednisolone capsules | EXPERIMENTAL | Within each cohort 6 subjects will be randomized to receive prednisolone 60mg oral capsules and 2 subjects randomized to receive matching placebo in a fasted state. Sentinel dosing will not be employed for the prednisolone cohort. The SRC will not be required to evaluate the prednisolone cohort. This cohort can be performed at any time during clinical execution of the study provided the protocol amendment was approved. |
| Name | Type | Description |
|---|---|---|
| AZD9567 Monohydrat | DRUG | AZD9567 oral suspension 0.5 to 10 mg/ml |
| Placebo oral suspension/ Placebo capsule | DRUG | Matching placebo |
| Prednisolone | DRUG | Prednisolone 60mg oral capsules (12 capsules of 5 mg each). |
Inclusion Criteria: * Provision of signed and dated, written informed consent prior to any study specific procedures. * Healthy male subjects aged 18 to 55 years with suitable veins for cannulation or repeated venipuncture. * Have a body mass index (BMI) between 18 and 29.9 kg/m2 inclusive and weig...
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AZD9567 Monohydrat is an investigational small molecule developed by AstraZeneca PLC for rheumatoid arthritis, an immunology condition. It has been studied in a Phase 1 clinical trial evaluating safety, tolerability, pharmacokinetics, and pharmacodynamics. The compound is not approved and remains in early clinical development.
AZD9567 Monohydrat is being investigated for the treatment of rheumatoid arthritis, an inflammatory joint disease. AstraZeneca PLC has studied it in a Phase 1 trial that enrolled healthy subjects and listed rheumatoid arthritis among the conditions assessed. It is an investigational agent and has not been approved for any use.
AZD9567 Monohydrat is developed by AstraZeneca PLC, which trades under the ticker AZN. The company sponsored the Phase 1 study of the compound conducted in Germany. AstraZeneca is the sole developer named for this asset.
AZD9567 Monohydrat is in Phase 1 development. One Phase 1 trial has been completed, and no active trials are ongoing. The study was a single ascending dose trial assessing safety, tolerability, pharmacokinetics, and pharmacodynamics. The drug is investigational and has not received regulatory approval.
AZD9567 Monohydrat has been studied in one completed Phase 1 trial, NCT02512575, titled a single ascending dose study to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of AZD9567. The trial enrolled 72 participants in Germany, was randomized and placebo controlled, and included male healthy volunteers aged 18 years and older.
AZD9567 Monohydrat is not approved. It is an investigational small molecule that has completed a single Phase 1 trial sponsored by AstraZeneca PLC. No regulatory approval has been granted, and the compound remains in early clinical development for rheumatoid arthritis.