A two part, randomized, double-blind, placebo-controlled, parallel group SAD and MD clinical study to evaluate the safety, tolerability and preliminary efficacy of an inhaled (nebulized) phage cocktail in healthy subjects and in patients with chronic colonization of the lung with Pseudomonas aeruginosa
Phase 1
- Conditions
- Pseudomonas colonizationMedDRA version: 21.1Level: LLTClassification code: 10068292Term: Pseudomonas colonization Class: 10021881Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
- Registration Number
- CTIS2022-503145-22-00
- Lead Sponsor
- Charite Research Organisation GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 32
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method