Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
AZD3199 · 5 trials · 6 indications
Peak effect (Emax) within 0-24 hours of FEV1, for treatment visits 2 to 7.
Trough effect (E22-26h) will be computed from the repeated measurements collected after each single dose during 22-26 hours of FEV1 from visit 2 to 7.
change from baseline
change from baseline
Maximum FEV1 value
Residual FEV1 24 h post-dose
Minimum S-potassium concentration (A well-known effect of beta2-agonists (AZD3199 is a beta2-agonist) is a reduction in serum potassium levels. The minimum value has therefore been evaluated.
Average S-potassium concentration
QTcF or QTcI (algorithm based decision)
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | AZD3199 800 µg inhaled via single inhaler device (SID), single dose |
| 2 | EXPERIMENTAL | AZD3199 880 µg inhaled via SID, single dose |
| 3 | EXPERIMENTAL | AZD3199 1400 µg inhaled via SID, single dose |
| 4 | EXPERIMENTAL | AZD3199 300 µg inhaled via Turbuhaler inhaler, single dose |
| 5 | EXPERIMENTAL | AZD3199 1200 µg inhaled via Turbuhaler inhaler, single dose |
| 6 | PLACEBO_COMPARATOR | Placebo inhaled via Turbuhaler inhaler and SID, single dose |
| crossover dose 1 | EXPERIMENTAL | AZD3199 120 microgram |
| crossover dose 2 | EXPERIMENTAL | AZD3199 480 microgram |
| crossover dose 3 | EXPERIMENTAL | AZD3199 1920 microgram |
| crossover dose 4 | PLACEBO_COMPARATOR | Placebo |
| crossover dose 5 | ACTIVE_COMPARATOR | Formoterol 9 microgram |
| crossover dose 6 | ACTIVE_COMPARATOR | Formoterol 36 microgram |
| Name | Type | Description |
|---|---|---|
| AZD3199 | DRUG | Inhaled via single inhaler device (SID) |
| AZD3199 Placebo | OTHER | Inhaled via Turbuhaler inhaler and SID |
| formoterol | DRUG | Dry powder for inhalation, b.i.d., 4 weeks |
| Placebo | DRUG | Dry powder for inhalation, b.i.d., 4 weeks |
| Moxifloxacin | DRUG | Single dose, oral encapsulated tablet |
| Placebo comparator | OTHER | Single dose, oral inhalation |
Inclusion Criteria: * Provision of signed and dated written informed consent prior to any study specific procedures * Men or women, age ≥ 18 years. Women must be of non-childbearing potential or stable on a highly effective contraceptive method for at least 3 months prior to Visit 1 and be willing ...
AZD3199 is an investigational small molecule being developed for respiratory conditions including chronic obstructive pulmonary disease (COPD) and asthma. It has been studied in healthy volunteers and patients with airway obstruction. The drug is administered as an inhaled formulation via a dry powder inhaler.
AZD3199 is being developed by AstraZeneca PLC, a multinational pharmaceutical company traded on the NASDAQ under the ticker symbol AZN. The drug has completed clinical trials in respiratory indications.
AZD3199 has completed Phase 1 and Phase 2 clinical trials. It is an investigational drug that has not been approved by regulatory authorities. The development program includes studies in healthy volunteers and patients with asthma or COPD.
AZD3199 has been studied in four completed clinical trials. These include NCT00713271, a Phase 1 multiple ascending dose study in healthy men; NCT00736489, a Phase 2 pharmacodynamics study in asthma patients; NCT01222442, a Phase 1 cardiac safety study; and NCT01348139, a Phase 2 pharmacokinetics study in asthma.
AZD3199 is a small molecule developed for respiratory diseases. It is designed to be delivered via inhalation to act locally in the lungs. The specific molecular target has not been disclosed in available clinical trial information.