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

• Status: Withdrawn
• Trial end date: 2010-04-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

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

Details

• Lead Sponsor: Pharmaxis

Criteria

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,