Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
AZD5634 · 1 trial · 1 indication
Assessment of the average whole lung clearance between 0 and 60 minutes after administration of single inhaled dose of aerosolized radiolabelled particles (colloids) of AZD5634, (%MCC 0--60, whole) in subjects with cystic fibrosis (CF).
| Arm | Type | Description |
|---|---|---|
| Placebo + AZD5634 | EXPERIMENTAL | Subjects were administered single dose of placebo in period 1 and AZD5634 in period 2. |
| AZD5634 + Placebo | EXPERIMENTAL | Subjects were administered single dose of AZD5634 in period 1 and placebo in period 2. |
| Name | Type | Description |
|---|---|---|
| Placebo | DRUG | Subjects will receive a placebo in either period 1 or period 2 by inhalation. |
| AZD5634 | DRUG | Subjects will receive a single tentative dose of 625 μg of AZD5634 in either period 1 or period 2 by inhalation. |
Inclusion Criteria: 1. Provision of signed and dated written informed consent prior to any study-specific procedures. 2. Male or female patients aged 18-60 years old inclusive. 3. Diagnosed of CF at Screening as evidenced in medical records by one of the following criteria: 1. sweat chloride ≥ ...
AZD5634 is an investigational small molecule being developed for cystic fibrosis and pulmonary or respiratory diseases. It is administered by inhalation and has been studied in adult patients with cystic fibrosis. The drug is still in clinical development and has not been approved by the FDA.
AZD5634 is being developed by AstraZeneca PLC, a biopharmaceutical company traded on the NASDAQ under the ticker symbol AZN. The drug is in Phase 1 clinical development for respiratory conditions including cystic fibrosis.
AZD5634 is in Phase 1 clinical development. It has completed two Phase 1 trials, one involving healthy volunteers and another in patients with cystic fibrosis. The drug is investigational and has not received FDA approval.
AZD5634 has completed two Phase 1 clinical trials. NCT02679729 assessed safety, tolerability, and pharmacokinetics after inhaled and intravenous dosing in healthy volunteers. NCT02950805 evaluated its effect on mucociliary clearance, safety, tolerability, and pharmacokinetics in patients with cystic fibrosis.
AZD5634 is the primary name for this investigational compound. No alternative names have been reported for this drug in clinical development.