Expired Study
This study is not currently recruiting Study Participants on ClinicalConnection.com. If you would like to find active studies please search for clinical trials.

Cypress, California 90630


Purpose:

This study evaluates the effect of pre-treatment with either cromolyn sodium or albuterol sulfate on the safety and tolerability or PUL-042 Inhalation Solution in healthy subjects.


Study summary:

Healthy subjects (8 per cohort) will be randomized to either pre-treatment or no pre-treatment (4 per group). The initial cohort will receive pre-treatment with cromolyn sodium. Subjects will be followed for 2 weeks for safety and tolerability, undergo a 2 week washout period and then be assigned to the alternative treatment (i.e., subjects who received cromolyn sodium prior to PUL-042 inhalation solution will not receive pretreatment) and then followed for an additional 2 weeks. Subsequent cohort will receive pre-treatment with albuterol sulfate in a like manner.


Criteria:

Inclusion Criteria: - Males or females of non-childbearing potential (defined as surgically sterilized [tubal ligation/hysterectomy/bilateral salpingo oophorectomy or post- menopausal for > 2 years) with a negative urine human chorionic gonadotropin (hCG) pregnancy test at the Screening Visit - Body Mass Index (BMI) between 18 and 30 kg/m2 - Ability to perform spirometry according to American Thoracic Society standards - Normal spirometry (forced expiratory volume in 1 second [FEV1] and forced vital capacity [FVC] ≥ 80% and ≤ 120% based on predicted values) at the Screening Visit and at Visit 2. - Pulse oximetry ≥95% on room air - Ability to understand and give informed consent - Males willing to practice contraception (condom + spermicide) during the study and for 30 days after completion of the Exclusion Criteria: - Febrile (temperature ≥ 99.5°Fahrenheit) - A history of use of any tobacco products during the year prior to the Screening Visit and a total exposure of > 5 pack years or a positive urine cotinine level at the Screening Visit - Clinically significant laboratory finding as determined by the Principal Investigator or designee at the Screening Visit or at Visit 2 - Positive test for drugs of abuse (alcohol, cannabinoids, opiates, cocaine, amphetamine, barbiturates, benzodiazepine, phencyclidine) - Any active medical problems requiring treatment - Subjects who exhibit symptoms of respiratory infection or have experienced respiratory symptoms of an upper respiratory infection within 30 days prior to the Screening Visit. - History of chronic pulmonary disease (eg, asthma [including atopic asthma, exercise induced asthma, or asthma triggered by respiratory infection], pulmonary fibrosis), pulmonary hypertension, or heart failure - Any out of range QTc Fridericia (QTcF) or other clinically significant ECG findings as determined by the Principal Investigator or designee at Visit 2 or Visit 12. - History of atopic reactions - Administration of any anti-inflammatory therapy (eg, no steroidal anti-inflammatory drugs or corticosteroids) within 4 weeks prior to randomization or expected to be ongoing during the study - An anticipated need for use of any inhaled medication during the study - Intake of coffee, tea, cola drinks, chocolate on days of Study Visits 1-21 - Intake of alcohol, caffeine or strenuous exercise within 72 hours prior to study drug administration or intake of grapefruit within 7 days prior to the administration of study drug - Intake of alcohol within 4 hours of spirometry; smoking within 1 hour of spirometry; performing vigorous exercise within 30 minutes of spirometry; wearing clothing that substantially restricts full chest and abdominal expansion; or eating a large meal within 2 hours of spirometry - Administration of any over the counter (OTC)/prescription medication, supplements, herbals or vitamins within 14 days prior to study drug administration. Administration of Tylenol within 72 hours of study drug administration (doses up to 2g/day will be allowed prior to 72 hours before study drug administration) - Exposure to any investigational agent within 30 days prior to the Screening Visit - Receipt of a flu vaccine in the last 3 months - Prior exposure to PUL-042 - Known positive for human immunodeficiency virus, or on active anti-retroviral therapy and known hepatitis B surface antigen positive or hepatitis C positive


Study is Available At:


Original ID:

PUL-042-003


NCT ID:

NCT02566252


Secondary ID:


Study Acronym:


Brief Title:

Effect of Pre-Treatment With Cromolyn or Albuterol on Response to PUL-042 Inhalation Solution (PUL-042)


Official Title:

A Randomized, Open-label, Crossover Study to Assess the Safety, Tolerability, and Pharmacodynamics of PUL-042 Inhalation Solution in Healthy Subjects and the Effect of Pretreatment With Cromolyn Sodium or Albuterol Sulfate


Overall Status:

Completed


Study Phase:

Phase 1


Genders:

N/A


Minimum Age:

18 Years


Maximum Age:

55 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Pulmotect, Inc.


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

3


Number of Groups:

0


Total Enrollment:

16


Enrollment Type:

Actual


Overall Contact Information

Official Name:Michelle Ababa, MD
Principal Investigator
West Coast Clinical Trials

Study Dates

Start Date:July 2015
Completion Date:March 2016
Completion Type:Actual
Primary Completion Date:January 2016
Primary Completion Type:Actual
Verification Date:August 2017
Last Changed Date:August 8, 2017
First Received Date:September 29, 2015

Study Outcomes

Outcome Type:Primary Outcome
Measure:Number of participants with treatment emergent, treatment-related adverse events as assessed by Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v4.0)
Time Frame:6 weeks
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:PUL-042 Inhalation Solution
Description:PUL-042
Arm Name:PUL-042
Intervention Type:Drug
Name:Cromolyn Sodium
Description:Pre-treatment
Arm Name:Cromolyn sodium
Intervention Type:Drug
Name:Albuterol sulfate
Description:Pre-treatment
Arm Name:Albuterol sulfate

Study Arms

Study Arm Type:Experimental
Arm Name:Albuterol sulfate
Description:Pre-Treatment with albuterol sulfate followed by PUL-042 Inhalation Solution Administration
Study Arm Type:Experimental
Arm Name:Cromolyn sodium
Description:Pre-Treatment with cromolyn sodium followed by PUL-042 Inhalation Solution Administration
Study Arm Type:Experimental
Arm Name:PUL-042
Description:PUL-042 Inhalation Solution

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Pulmotect, Inc.
Agency Class:Industry
Agency Type:Collaborator
Agency Name:WCCT Global

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


This study is not currently recruiting Study Participants. The form below is not enabled.