Safety, Tolerability, Pharmacodynamics and Pharmacokinetics of Inhaled TPI 1100 in Healthy Volunteers

A Phase 1,Randomized, Double--blind, Placebo-controlled Study Assessing the Safety and Tolerability, the Pharmacodynamics and Pharmacokinetics of Single-ascending and Repeated Doses of Inhaled TPI 1100 in Healthy Subjects

This study will look at the safety and tolerability of TPI 1100 in healthy volunteers and look at pharmacodynamic (PD) effect on mRNA expression of PDE 4B/D & 7A in blood and in sputum.

Study was not initiated and terminated before start-up.

Inclusion Criteria:

• Healthy, male or female volunteers aged 18 to 55 years inclusive
• Screening/baseline FEV1 greater than 90% predicted,
• Body mass index (BMI) of 19 to 28 inclusive,
• Clinical laboratory values and/or vital signs within normal reference ranges or not considered clinically significant by the Investigator

Exclusion Criteria:

• Airways or systemic conditions that might affect respiratory function, including but not limited to clinically significant cardiac problems,
• Breast-feeding or pregnancy,
• Positive tests for smoking tobacco, alcohol, hepatitis B-surface antigen, hepatitis C antibody, and HIV at screening,
• History of serious adverse reaction to any drugs,