MedTrace Logo

Ph 1/2 Study Evaluating Safety and Tolerability of Inhaled AP-PA02 in Subjects With Chronic Pseudomonas Aeruginosa Lung Infections and Cystic Fibrosis

NCT04596319 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 29

Last updated 2024-01-31

Study results available
· View outcomes & findings →

Summary

Phase 1b/2a, double-blind, randomized, placebo-controlled, single and multiple ascending dose study to evaluate the safety, tolerability and phage recovery profile of AP-PA02 multi-bacteriophage therapeutic candidate administered by inhalation in subjects with cystic fibrosis and chronic pulmonary Pseudomonas aeruginosa (PA) infection.

Conditions

  • Cystic Fibrosis
  • Pseudomonas Aeruginosa
  • Pseudomonas
  • Lung Infection
  • Lung Infection Pseudomonal

Interventions

BIOLOGICAL

AP-PA02

Bacteriophage administered via inhalation

OTHER

Placebo

Inactive Placebo administered via inhalation

Sponsors & Collaborators

  • Cystic Fibrosis Foundation

    collaborator OTHER

  • Armata Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Mina Pastagia, MD, MS · Armata Pharmaceuticals, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-22
Primary Completion
2022-12-14
Completion
2022-12-14
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04596319 on ClinicalTrials.gov