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

• Status: Completed
• Trial end date: 2014-10-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Pulmotect, Inc.
• Treatments: Pam2CSK4 acetate and ODN M362 combination; Pharmaceutical Solutions

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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