Safety, Tolerability, and Pharmacodynamic Effect Study of PUR118

NCT01333904 | Completed Phase 1

• 1 other identifier: 601-0004
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to establish single and multiple dose safety in healthy subjects and subjects with mild chronic pulmonary obstructive disease (COPD). In addition, the study will evaluate preliminary proof of concept endpoints in COPD subjects such as biomarkers in sputum and mucociliary clearance.

Conditions

Chronic Obstructive Pulmonary Disease

Outcome Measures

Primary Outcomes (1)

• Safety and tolerability assessed by changes in clinical signs and symptoms, clinical safety laboratory tests, vital signs, ECG, spirometry, oxygen saturation, telemetry and adverse events

  2 weeks

Secondary Outcomes (2)

• Assessment of biomarkers of inflammation and COPD in induced sputum in mild COPD subjects after short multi-dosing with PUR118 compared to baseline

  2 days

• Assessment of changes in mucociliary clearance after treatment with PUR118 in mild COPD subjects compared to baseline

  single dose

Study Arms (1)

PUR118

EXPERIMENTAL

Drug: PUR118

Interventions

PUR118 DRUG

inhaled

PUR118

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy males or non pregnant, non lactating healthy females;
• Age 18-65 years of age;
• Must be willing and able to communicate in English and participate in the whole study;
• Must provide written informed consent.

You may not qualify if:

• Current smokers and those who have smoked within the last 12 months;
• Females of child bearing age not willing to use an acceptable form of contraception;
• Presence or history of allergy requiring treatment;
• Serious adverse reaction or hypersensitivity to any drug;
• Males or non pregnant, non lactating females;
• Age 45-70 years;
• Current (Part III only) or ex-smokers who at least a 15 pack-year smoking history. For Part IV, subjects must be non-smokers for at least 3 months;
• Medically stable, with no evidence of uncontrolled co-existing conditions at screening;
• Must not be taking any inhaled or oral corticosteroids;
• FEV1/FVC ratio \<70% and FEV1 60 - 80% (or \>/= 60% for Part IV only) of predicted following administration of a bronchodilator;
• Patients must have a medical history of COPD confirmed by their General Practitioner (GP) or treating hospital physician or must have a chest x-ray (CXR) which is normal or consistent with mild COPD and excludes other clinically significant respiratory abnormalities;
• Must be willing and able to communicate in English and participate in the whole study;
• Must provide written informed consent.
• Must agree to use an adequate method of contraception;
• Upper respiratory tract infection within 30 days of the first study day, or lower respiratory tract infection within the last 60 days;

Sponsors & Collaborators

• Pulmatrix Inc.: lead
• Quotient Bioresearch: collaborator

Study Sites (1)

Quotient Bioresearch

Nottingham, United Kingdom, NG11 6JS, United Kingdom

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Stuart Mair, MD

  Quotient Bioresearch

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2011
• First Posted: April 12, 2011
• Study Start: February 1, 2011
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2012
• Last Updated: September 7, 2012

Record last verified: 2012-09

Locations

GB (1)