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Safety and Tolerability of Single Ascending Doses of PUL-042 Inhalation Solution in Healthy Subjects

Primary Purpose

Healthy

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

PUL-042 Inhalation Solution

About this trial

This is an interventional prevention trial for Healthy focused on measuring Single ascending dose, Safety and tolerability in healthy subjects

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

ICON Development Solutions

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

PUL-042 Inhalation Solution

Sterile water for injection

Arm Description

Fixed 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 administered by nebulization

Outcomes

Primary Outcome Measures

Dose-limiting toxicities (DLTs)

Secondary Outcome Measures

Full Information

NCT ID

NCT02124278

First Posted

April 24, 2014

Last Updated

April 28, 2015

Sponsor

Pulmotect, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT02124278

Brief Title

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

2. Study Status

Record Verification Date

April 2015

Overall Recruitment Status

Completed

Study Start Date

February 2014 (undefined)

Primary Completion Date

October 2014 (Actual)

Study Completion Date

October 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Pulmotect, Inc.

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Healthy

Keywords

Single ascending dose, Safety and tolerability in healthy subjects

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

42 (Actual)

8. Arms, Groups, and Interventions

Arm Title

PUL-042 Inhalation Solution

Arm Type

Experimental

Arm Description

Arm Title

Sterile water for injection

Arm Type

Placebo Comparator

Arm Description

Sterile water for injection administered by nebulization

Intervention Type

Drug

Intervention Name(s)

PUL-042 Inhalation Solution

Primary Outcome Measure Information:

Title

Dose-limiting toxicities (DLTs)

Time Frame

Dosing to one week post-dose

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

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

Facility Information:

Facility Name

ICON Development Solutions

City

San Antonio

State/Province

Texas

ZIP/Postal Code

77027

Country

United States

12. IPD Sharing Statement

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Safety and Tolerability of Single Ascending Doses of PUL-042 Inhalation Solution in Healthy Subjects

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