Clinical trial NCT02124278: Safety and Tolerability of Single Ascending Doses of PUL-042 Inhalation Solution in Healthy Subjects
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Single ascending dose
Safety and tolerability in healthy subjects
Lead sponsor: Pulmotect, Inc.
Sponsor class: INDUSTRY
First posted: 2014-04-28
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Dose-limiting toxicities (DLTs)
timeFrame: Dosing to one week post-dose
Secondary outcomes:
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: ICON Development Solutions
state: Texas
Study officials:
References: