Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as AZD5055 oral suspension
AZD5055 · 1 trial · 1 indication
To investigate the safety and tolerability of AZD5055 by assessment of AEs (non-serious and serious) following administration of SAD
To investigate the safety and tolerability of AZD5055 by assessment of AEs (non-serious and serious) following administration of MAD
| Arm | Type | Description |
|---|---|---|
| Part 1 (single ascending doses [SAD]) | EXPERIMENTAL | Healthy participants will be randomized to a single dose of AZD5055 or placebo. |
| Part 2 (multiple ascending doses [MAD]) | EXPERIMENTAL | Healthy participants will be randomized to repeated dosing with AZD5055 or placebo |
| Name | Type | Description |
|---|---|---|
| AZD5055 | DRUG | Healthy participants will receive AZD5055 |
| Placebo | DRUG | Healthy participants will receive placebo |
Inclusion Criteria * Healthy male and female (of non-childbearing potential) subjects aged Part 1 (SAD): 18 - 55 years; Part 2 (MAD): 18 - 55 for male and 18 -49 for females, inclusive, with suitable veins for cannulation or repeated venipuncture. * Female subjects must have a negative pregnancy te...
Top 15 of 17 competitors
AZD5055 is being developed for idiopathic pulmonary fibrosis, a progressive lung disease marked by scarring of lung tissue. It is an investigational small molecule and has not been approved for any indication. The completed Phase 1 study enrolled healthy participants rather than patients with idiopathic pulmonary fibrosis.
AZD5055 is developed by AstraZeneca PLC, which trades on the Nasdaq under the ticker AZN. AstraZeneca is the sponsor of the clinical program for the asset in idiopathic pulmonary fibrosis.
AZD5055 is in Phase 1 development. One Phase 1 trial has been completed, and no active trials are currently listed. The drug remains investigational and has not been approved by the FDA or any other regulator for idiopathic pulmonary fibrosis or any other condition.
AZD5055 has been studied in one completed Phase 1 trial, NCT05134727, titled a study to assess the safety, tolerability and pharmacokinetics of AZD5055 following single and multiple ascending doses in healthy participants. It was a randomized, double-blind, controlled trial that enrolled 63 healthy volunteers in the United States.
Yes. AZD5055 oral suspension is an alternative name for AZD5055, referring to the oral suspension formulation of the same investigational small molecule being developed by AstraZeneca for idiopathic pulmonary fibrosis.