Safety and Tolerability of Single Ascending Doses of PUL-042 Inhalation Solution in Healthy Subjects

Completed · Phase 1

Conditions studied: Healthy

In brief

The purpose is to determine if single doses of PUL-042 inhalation solution are safe in healthy subjects.

Key facts

Study ID

NCT02124278

Run by

Pulmotect, Inc.

People needed

42

Starts

2014-02-01

Expected to finish

2014-10-01

Last updated by the study team

2015-04-29

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Males or females of non-childbearing potential
• Body mass index between 18 and 30 kg/m2
• Normal spirometry
• Normal diffusing capacity of lung for carbon monoxide
• Normal pulse oximetry
• Males willing to practice contraception or have a female partner using contraception

You may not qualify if…

• Febrile
• Abnormal chest x-ray
• History of tobacco products within the last year and total exposure of > 5 pack/years
• Clinically significant laboratory findings
• History of chronic pulmonary disease
• History of atopic reactions
• Mediastinal lymphadenopathy
• Oral corticosteroid therapy within 4 weeks prior to randomization
• Alcohol, caffeine or strenuous exercise within 72 hours prior to dosing
• Grapefruit within 7 days prior to dosing
• Administration of concomitant medications within 14 days prior to dosing
• Exposure to any investigational agent with 30 days
• Significant concurrent illness
• Know positive for HIV, hepatitis B or hepatitis C
• Inability to tolerate a nebulization test with sterile water for injection
• Positive test for drugs of abuse

Where it is running

• ICON Development Solutions — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.