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

NCT ID: NCT02124278

Last Updated: 2015-04-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-02-28
• Study Completion Date: 2014-10-31

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.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

PUL-042 Inhalation Solution

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.

Group Type: EXPERIMENTAL

PUL-042 Inhalation Solution

Intervention Type: DRUG

Sterile water for injection

Sterile water for injection administered by nebulization

Group Type: PLACEBO_COMPARATOR

PUL-042 Inhalation Solution

Intervention Type: DRUG

Interventions

PUL-042 Inhalation Solution

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Pulmotect, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

ICON Development Solutions

San Antonio, Texas, United States

Countries

United States

Other Identifiers

PUL-042-001

Identifier Type: -

Identifier Source: org_study_id