Status:
WITHDRAWN
Safety, Tolerability, Pharmacodynamics and Pharmacokinetics of Inhaled TPI 1100 in Healthy Volunteers
Lead Sponsor:
Syntara
Conditions:
Chronic Obstructive Pulmonary Disease
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief 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.
Detailed Description
Study was not initiated and terminated before start-up.
Eligibility Criteria
Inclusion
- 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
- 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,
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2010
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00914433
Start Date
April 1 2009
End Date
April 1 2010
Last Update
December 3 2012
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