Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
HFO-1234ze · 1 trial · 1 indication
Change from baseline in MCC through 60 minutes, following inhalation of 99m technetium-labelled colloid (sulfur or albumin) and gamma camera imaging
| Arm | Type | Description |
|---|---|---|
| Treatment A: HFO MDI | EXPERIMENTAL | Test arm, 6 inhalations BID for 7 days |
| Treatment B: HFA MDI | ACTIVE_COMPARATOR | Reference arm, 6 inhalations BID for 7 days |
| Name | Type | Description |
|---|---|---|
| HFO-1234ze(E) | DRUG | * Dose formulation: metered dose inhaler (MDI) * Unit dose strength(s): Experimental (propellant only) * Dosage level(s): 6 inhalations, BID * Route of administration: Oral inhalation * Participants will receive treatment A in 1 of 2 possible treatment sequences: AB or BA |
| HFA-134a | DRUG | * Dose formulation: metered dose inhaler (MDI) * Unit dose strength(s): Reference (propellant only) * Dosage level(s): 6 inhalations, BID * Route of administration: Oral inhalation * Participants will receive treatment B in 1 of 2 possible treatment sequences: AB or BA. |
Inclusion Criteria: Participants are eligible to be included in the study only if all of the following criteria apply: 1. Capable of giving signed informed consent as described in the protocol which includes compliance with the requirements and restrictions listed in the informed consent form (ICF...
HFO-1234ze is an investigational small molecule being developed for mucociliary clearance, a respiratory condition. It is currently in Phase 3 clinical development. The drug is being studied as a next-generation propellant metered-dose inhaler (MDI) to assess its effect on mucociliary clearance compared to an HFA propellant MDI.
HFO-1234ze is being developed by AstraZeneca PLC, a biopharmaceutical company listed on the stock exchange under the ticker AZN. The company is conducting clinical trials to evaluate the drug's effect on mucociliary clearance in healthy participants.
HFO-1234ze is in Phase 3 clinical development. It is an investigational drug and has not been approved by regulatory authorities. One Phase 3 trial has been completed, involving 35 participants, to evaluate its effect on mucociliary clearance compared to an HFA propellant MDI.
HFO-1234ze has one completed clinical trial registered under NCT05755932. The study, titled 'Study to Assess Effect of Next-Generation Propellant MDI on Mucociliary Clearance Vs. HFA Propellant MDI in Healthy Participants,' was a Phase 3, randomized, double-blind, active-controlled trial with 35 healthy volunteers in the United States and United Kingdom.
HFO-1234ze is not FDA approved. It is an investigational drug currently in Phase 3 clinical development. A completed Phase 3 trial has assessed its effect on mucociliary clearance, but the drug has not yet received regulatory approval for any indication.