NCT03097796

A Multiple Ascending Dose Study of PUL-042 in Stem Cell Transplant Recipients

An Open-Label, Multiple Ascending Dose Study to Evaluate the Safety and Tolerability of PUL-042 Inhalation Solution in Subjects With Hematologic Malignancies and Recipients of Stem Cell Transplantation

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Pulmotect, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Subjects with hematologic malignancies or recipients of a first allogenic or autologus hematopoietic stem cell transplant, without any evidence or respiratory infection, will receive 4 doses of PUL-042 Inhalation Solution over a 2 week period. Subjects will be evaluated for tolerability of the drug. If tolerated, dose escalation may occur with up to 4 dose levels tested

Detailed description

This is an open-label multiple ascending dose study with a 3+3 study design to examine the safety and tolerability of PUL-042 Inhalation Solution in subjects with hematologic malignancies or recipients of a first allogenic or autologus hematopoietic stem cell transplant. Subjects will receive 4 doses over 2 weeks. Cohort size will be 3 subjects, once 3 subjects have completed treatment and follow-up at a dose level, subject data will be evaluated by an independent data safety monitoring committee prior to dosing additional subjects. The Committee may recommend increasing the dose, maintaining the same dose, or decreasing the dose. Once the maximum dose is determined, there may be up to 6 additional subjects dosed at that level.

Conditions

• Hematologic Diseases
• Stem Cell Transplants

Interventions

Type	Name	Description
DRUG	PUL-042	PUL-042 Inhalation Solution

Timeline

• Start date: 2024-12-01
• Primary completion: 2026-03-01
• Completion: 2026-05-01
• First posted: 2017-03-31
• Last updated: 2023-04-27

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study