Conditions: Healthy Cystic Fibrosis
Allocation: NON_RANDOMIZED | Intervention model: PARALLEL
Enrollment: 25
Healthy volunteers: yes

Brief summary:
The study is carried out to evaluate the safety, tolerability and pharmacokinetics of AeroVanc inhalation powder in healthy volunteers, and in patients with cystic fibrosis.

Detailed description:
The study has three main objectives:

* To evaluate the safety, and tolerability of AeroVanc inhalation powder in healthy volunteers, and in patients with CF.
* To determine the systemic bioavailability of vancomycin in healthy volunteers following single dose pulmonary administration of 16 mg, 32 mg, and 80 mg doses of AeroVanc in comparison with a 250 mg dose of vancomycin administered intravenously.
* To estimate the lung sputum concentrations of vancomycin in patients with cystic fibrosis (CF) following single dose pulmonary administration of 32 mg and 80 mg doses of AeroVanc.

Arms:
arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None arm 6: None

Interventions: intervention 1: AeroVanc intervention 2: IV vancomycin hydrochloride
Intervention descriptions: intervention 1: Vancomycin hydrochloride dry powder for inhalation intervention 2: Vancomycin hydrochloride solution for intravenous administration

Protocol document: