Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
AZD7624 · 4 trials · 5 indications
Summary of number of subjects who had at least one adverse event in any category (Safety analysis set)
| Arm | Type | Description |
|---|---|---|
| AZD7624 | EXPERIMENTAL | Active treatment |
| Placebo | PLACEBO_COMPARATOR | Placebo Comparator |
| 1 | EXPERIMENTAL | Groups 1-4 multiple ascending doses of AZD7624 Healthy subjects will participate in groups 1-3. In each group 6 subjects will receive AZD7624 and 2 will receive matching placebo. COPD patients will participate in group 4. In this group, 8 patients will receive AZD7624 and 2 patients will receive matching placebo. |
| 2 | PLACEBO_COMPARATOR | Groups 1-4 multiple ascending doses of placebo Healthy subjects will participate in groups 1-3. In each group 6 subjects will receive AZD7624 and 2 will receive matching placebo. COPD patients will participate in group 4. In this group, 8 patients will receive AZD7624 and 2 will receive matching placebo. |
| Group 1-5, single ascending dose AZD7624 | EXPERIMENTAL | Subjects will participate in 1 of 5 groups. In each group 6 subjects will receive AZD7624 and 2 subjects will receive matching placebo. |
| Name | Type | Description |
|---|---|---|
| AZD7624 1.0 mg | DRUG | Inhaled AZD7624 solution, 11 mg/mL |
| Placebo | DRUG | Inhaled placebo solution |
| AZD7624 | DRUG | nebuliser solution; 20 mg/mL for inhalation |
| Placebo to match | DRUG | Multiple doses inhaled placebo via a nebulizer |
Inclusion Criteria: * Provision of signed and dated written informed consent prior to any study specific procedures. * Male and females aged 40-85 years. Females must have a negative pregnancy test at Visit 1, must not be lactating and must be of non-childbearing potential. Males must be surgically...
AZD7624 is an investigational small molecule developed by AstraZeneca PLC for respiratory conditions, primarily chronic obstructive pulmonary disease (COPD). It has been studied in clinical trials involving COPD patients and healthy volunteers, including studies of inflammation triggered by an endotoxin challenge. It is not an approved medicine and remains in clinical development.
AZD7624 has been studied in chronic obstructive pulmonary disease (COPD), including a Phase IIa trial in COPD patients receiving maintenance therapy. That trial evaluated efficacy and safety in 213 randomized, double-blind, placebo-controlled participants across the United States, Argentina, Chile, the Netherlands, Peru, and South Africa. AZD7624 is investigational and not approved for COPD treatment.
AZD7624 is developed by AstraZeneca PLC, which trades under the ticker AZN. AstraZeneca sponsored the clinical program for the compound, including the Phase I and Phase IIa studies conducted in the United Kingdom and multiple other countries.
AZD7624 is in clinical development. Its program includes Phase I studies and a Phase IIa study in COPD patients, and all listed trials have been completed. AZD7624 is investigational and has not been approved by the FDA for any indication.
AZD7624 has been evaluated in completed trials including NCT02238483, a Phase IIa COPD study with 213 participants; NCT01937338, a Phase I endotoxin challenge study with 60 healthy volunteers; NCT01817855, a Phase I safety and pharmacokinetics study with 52 participants; and NCT01754844, a first-in-human Phase I study with 57 healthy subjects.