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

Syntara

Status and phase: Withdrawn; Phase 1

Conditions: Chronic Obstructive Pulmonary Disease

Treatments: Drug: TPI 1100

Study type: Interventional

Funder types: Industry

Identifiers

NCT00914433

TPI 1100-101

Details and patient eligibility

About

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.

Full description

Study was not initiated and terminated before start-up.

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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,

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: Triple Blind

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0 participants in 1 patient group

TPI 1100

Experimental group

Description:

Drug to be given by inhalation.

Treatment:

Drug: TPI 1100