Healthy
Conditions
Keywords
Single ascending dose, Safety and tolerability in healthy subjects
Brief summary
The purpose is to determine if single doses of PUL-042 inhalation solution are safe in healthy subjects.
Detailed description
The study will assess the safety, tolerability, pharmacokinetics and pharmacodynamics of single ascending doses of PUL-042 inhalation solutions in healthy subjects. Subjects will be enter a screening period of up to 14 days to determine eligibility. Subjects will be admitted to the Phase 1 unit the day prior to dosing and remain in the unit until 24 hours post-dose. Subjects will be seen in the clinic at 3 and 7 days post-dose A modified 3+3 design will be used to determine the maximum tolerated dose (MTD) based on the occurrence of dose-limiting toxicities (DLTs) defined by Common Terminology Criteria for Adverse Events (CTCAE) v4. Additional specific DLTs will be defined as: 1) Hypoxia, defined as a non-artifactual drop in pulse oximetry to \< 90% on room air, 2) A decrease in forced expiratory volume in one second (FEV1) of 12% or greater compared to the last observation prior to dosing, 3) Any evidence of bronchospasm or wheezing requiring medical intervention. Doses will be doubled until the maximum tolerated dose (MTD- defined as the largest dose with 0/6 or 1/6 DLTs) is reached.
Interventions
Sponsors
Pulmotect, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Males or females of non-childbearing potential * Body mass index between 18 and 30 kg/m2 * Normal spirometry * Normal diffusing capacity of lung for carbon monoxide * Normal pulse oximetry * Males willing to practice contraception or have a female partner using contraception
Exclusion criteria
* Febrile * Abnormal chest x-ray * History of tobacco products within the last year and total exposure of \> 5 pack/years * Clinically significant laboratory findings * History of chronic pulmonary disease * History of atopic reactions * Mediastinal lymphadenopathy * Oral corticosteroid therapy within 4 weeks prior to randomization * Alcohol, caffeine or strenuous exercise within 72 hours prior to dosing * Grapefruit within 7 days prior to dosing * Administration of concomitant medications within 14 days prior to dosing * Exposure to any investigational agent with 30 days * Significant concurrent illness * Know positive for HIV, hepatitis B or hepatitis C * Inability to tolerate a nebulization test with sterile water for injection * Positive test for drugs of abuse
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Dose-limiting toxicities (DLTs) | Dosing to one week post-dose |
Countries
United States
Outcome results
None listed