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

Status

Withdrawn

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00914433

Enrollment

Registered

2009-06-05

Start date

2009-04-30

Completion date

2010-04-30

Last updated

2012-12-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

COPD

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.

Interventions

DRUGTPI 1100

1 dose only increasing dose

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

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,

Design outcomes

Primary

Measure	Time frame
Airway-specific and general safety and tolerability.	24 hours post-dose and on Day 4

Secondary

Measure	Time frame
Effect on mRNA	24 hrs post-dose and on Day 4

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026