Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
AeroVanc · 1 trial · 2 indications
Each participant was monitored regularly for Adverse Events (AEs) throughout the study. The Investigator or designee enquired about AEs by asking participants non-leading questions such as: "How do you feel?" or "Have you had any (other) medical problems since your last visit/assessment?" Additionally, several safety procedures (physical examinations, vital signs, safety laboratory tests, 12-lead ECGs, and spirometry) were conducted on participants at regular intervals. All AEs reported spontaneously by participants or in response to questioning or observation by the Investigator, including those related to safety procedures, were recorded. For each AE, the Investigator recorded the following assessments: seriousness, severity (Mild, Moderate, or Severe), and relationship to study drug (Not Related, Remote, Possible, Probable, or Highly Probable). AEs were considered drug-related if given a relationship of Possible, Probable, or Highly Probable.
| Arm | Type | Description |
|---|---|---|
| Aerovanc 16 mg in healthy volunteers | EXPERIMENTAL | - |
| AeroVanc 32 mg in healthy volunteers | EXPERIMENTAL | - |
| AeroVanc 80 mg in healthy volunteers | EXPERIMENTAL | - |
| IV vancomycin in healthy volunteers | ACTIVE_COMPARATOR | - |
| AeroVanc 32 mg in CF patients | EXPERIMENTAL | - |
| AeroVanc 80 mg in CF patients | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| AeroVanc | DRUG | Vancomycin hydrochloride dry powder for inhalation |
| IV vancomycin hydrochloride | DRUG | Vancomycin hydrochloride solution for intravenous administration |
Inclusion Criteria Healthy Volunteers: 1. Healthy male volunteers between 18 and 50 years of age inclusive. 2. Able to communicate with site personnel and to understand and voluntarily sign the Informed Consent Form. 3. Able and willing to comply with the Protocol, including availability for all sc...
AeroVanc is an investigational inhaled formulation of vancomycin being developed by Savara, Inc. (SVRA) for respiratory use. It is a small molecule therapeutic in Phase 1 clinical development. AeroVanc is designed for administration via inhalation, targeting respiratory conditions.
AeroVanc is being studied for use in respiratory conditions, specifically in healthy volunteers and patients with cystic fibrosis. The Phase 1 clinical trial evaluated its tolerability, safety, and pharmacokinetics when inhaled. It is intended to deliver vancomycin directly to the lungs.
AeroVanc is being developed by Savara, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol SVRA. Savara focuses on respiratory therapies and is advancing AeroVanc through clinical development.
AeroVanc is in Phase 1 clinical development. The Phase 1 trial, NCT01537666, has been completed. AeroVanc is an investigational drug and has not been approved by regulatory authorities. It remains in early-stage clinical testing.
AeroVanc has one completed Phase 1 clinical trial, NCT01537666, titled "Inhaled Vancomycin Tolerability, Safety and Pharmacokinetics." The trial enrolled 25 participants, including healthy volunteers and individuals with cystic fibrosis, and was conducted in Australia. It was an active-controlled study.
AeroVanc is an inhaled formulation of vancomycin, an antibiotic that works by inhibiting bacterial cell wall synthesis. By delivering vancomycin directly to the lungs via inhalation, AeroVanc aims to achieve high local concentrations of the antibiotic in the respiratory tract.