Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
LAS190792 Dose 1 · 1 trial · 2 indications
Adverse events (AEs) are any unfavorable and unintended medical occurrence during the subject's participation in the study (including deterioration of a pre-existing medical condition, an abnormal value in a laboratory assessment, an ECG abnormality, a 12-lead 24-hour ECG-Holter abnormality, a blood pressure abnormal value, paradoxal bronchospasm or an abnormal finding in the physical examination) and will be coded using the current Medical Dictionary for Regulatory Activities (MedDRA).
Trough is defined as the mean of the FEV1 values obtained at 23 hours and at 24 hours after morning investigational product administration.
| Arm | Type | Description |
|---|---|---|
| LAS190792 Dose 1 (Part 1) | EXPERIMENTAL | Single dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI) |
| LAS190792 Dose 2 (Part 1) | EXPERIMENTAL | Single dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI) |
| LAS190792 Dose 3 (Part 1) | EXPERIMENTAL | Single dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI) |
| LAS190792 Dose 4 (Part 1) | EXPERIMENTAL | Single dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI) |
| LAS190792 Dose 5 (Part 1) | EXPERIMENTAL | Single dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI) |
| LAS190792 Dose 6 (Part 1) | EXPERIMENTAL | Single dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI) |
| Placebo (Part 1) | PLACEBO_COMPARATOR | Single dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI) |
| LAS190792 Dose 1 (Part 2) | EXPERIMENTAL | Single dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI) |
| LAS190792 Dose 2 (Part 2) | EXPERIMENTAL | Single dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI) |
| Tiotropium 18 μg | ACTIVE_COMPARATOR | Single dose, oral inhalation by HandiHaler® single-dose DPI |
| Indacaterol 150 μg | ACTIVE_COMPARATOR | Single dose, oral inhalation by Breezhaler® single-dose DPI |
| Placebo (Part 2) | PLACEBO_COMPARATOR | Single dose, oral inhalation by Genuair® single-dose dry powder inhaler (DPI) |
| Name | Type | Description |
|---|---|---|
| LAS190792 Dose 1 | DRUG | - |
| LAS190792 Dose 2 | DRUG | - |
| LAS190792 Dose 3 | DRUG | - |
| LAS190792 Dose 4 | DRUG | - |
| LAS190792 Dose 5 | DRUG | - |
| LAS190792 Dose 6 | DRUG | - |
| LAS190792 Dose 1 (Part 2) | DRUG | - |
| LAS190792 Dose 2 (Part 2) | DRUG | - |
| Tiotropium 18 μg | DRUG | - |
| Indacaterol 150 μg | DRUG | - |
| Placebo | DRUG | - |
Inclusion Criteria (PART 1): * Adult male subjects aged 18 to 70 years * Body mass index (BMI) 18.5 to 30 kg/m2 at screening * Clinical diagnosis of mild persistent asthma (according to GINA guidelines) for at least 6 months prior to screening * Ability to change current asthma therapy, to disconti...
LAS190792 Dose 1 is an investigational small molecule being studied for the treatment of chronic obstructive pulmonary disease (COPD). It has also been evaluated in patients with asthma. It is not an approved therapy and remains in clinical development.
LAS190792 Dose 1 targets ADRB2 (the beta-2 adrenergic receptor) and CHRM3 (the M3 muscarinic receptor). It acts as an agonist at these receptors, combining beta-2 agonist and muscarinic antagonist activity in a single small molecule for airway effects in COPD.
LAS190792 Dose 1 is being developed by AstraZeneca PLC, which trades on the Nasdaq under the ticker AZN. AstraZeneca is the sponsor of the clinical program evaluating this compound in respiratory conditions.
LAS190792 Dose 1 is in Phase 1 clinical development. It is an investigational agent and has not been approved by the FDA or any other regulatory authority for COPD or any other indication.
LAS190792 Dose 1 has been studied in one completed Phase 1 trial, NCT02059434, titled a two-part pharmacokinetic and pharmacodynamic study in patients with asthma and COPD. The trial enrolled 55 participants in the United Kingdom and was randomized and placebo-controlled.