INNA-051 dry powder safety and tolerability study

Phase 1

• Conditions: Respiratory infection; Infection - Other infectious diseases; Respiratory - Other respiratory disorders / diseases

• Registration Number: ACTRN12624000635561
• Lead Sponsor: ENA Respiratory Pty Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-05-16
• Last Update Posted: 21 May 2024

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Males and females 60 years of age or older
Without clinically defined unstable disease, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring.
- Body weight 50 kg or above and body mass index (BMI) 18 to 34.9 kg/m2 (inclusive).
- Forced expiratory volume in one second (FEV1) at least 80% of the predicted value at Screening.

Exclusion Criteria

- Any significant disease or disorder which may put the subject at risk because of participation in the study, influence the results of the study or the participant’s ability to participate in the study.
- History or evidence of tachyarrhythmias, heart block, or ischemic changes.
- Clinically significant abnormal laboratory assessments
- Chronic tobacco use, chronic cannabis smoking, or chronic vaping.
- Nasal conditions likely to affect the outcome of the study, for example nasal septal perforation, nasal polyps, other nasal malformations, or history of frequent nosebleeds.
- Active rhinitis, including allergic, non-allergic rhinitis and rhinosinusitis
- Upper respiratory tract infection or nasal symptoms

Study & Design

• Study Type: Interventional
• Study Design: Not specified