Safety and Tolerability of Single Ascending Doses of PUL-042 Inhalation Solution in Healthy Subjects
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
1 other identifier
interventional
42
1 country
1
Brief Summary
The purpose is to determine if single doses of PUL-042 inhalation solution are safe in healthy subjects.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1 healthy
Started Feb 2014
Typical duration for phase_1 healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2014
CompletedFirst Submitted
Initial submission to the registry
April 24, 2014
CompletedFirst Posted
Study publicly available on registry
April 28, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2014
CompletedApril 29, 2015
April 1, 2015
8 months
April 24, 2014
April 28, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Dose-limiting toxicities (DLTs)
Dosing to one week post-dose
Study Arms (2)
PUL-042 Inhalation Solution
EXPERIMENTALFixed dose combination of Pam2CSK4 acetate (Pam2) and ODN M362 (ODN) administered as an inhalation solution. Single dose administration by nebulization. Starting dose will be 2.9 micrograms Pam2: 4.25 micrograms ODN. Up to 7 doubling doses may be tested.
Sterile water for injection
PLACEBO COMPARATORSterile water for injection administered by nebulization
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pulmotect, Inc.lead
Study Sites (1)
ICON Development Solutions
San Antonio, Texas, 77027, United States
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 24, 2014
First Posted
April 28, 2014
Study Start
February 1, 2014
Primary Completion
October 1, 2014
Study Completion
October 1, 2014
Last Updated
April 29, 2015
Record last verified: 2015-04