Safety and Tolerability of Single Ascending Doses of PUL-042 Inhalation Solution in Healthy Subjects
| Status: | Completed |
|---|---|
| Conditions: | Healthy Studies |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - 55 |
| Updated: | 4/13/2015 |
| Start Date: | February 2014 |
| End Date: | August 2014 |
| Contact: | Atul Varadhachary, MD |
| Email: | atul@fannininnovation.com |
| Phone: | 832-315-4807 |
A Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of PUL-042 Inhalation Solution in Healthy Subjects
The purpose is to determine if single doses of PUL-042 inhalation solution are safe in
healthy subjects.
healthy subjects.
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.
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.
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
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