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

NCT03097796 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2023-04-27

No results posted yet for this study

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

Conditions

Interventions

DRUG

PUL-042

PUL-042 Inhalation Solution

Sponsors & Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

    collaborator NIH

  • Cancer Prevention Research Institute of Texas

    collaborator OTHER

  • Pulmotect, Inc.

    lead INDUSTRY

Principal Investigators

  • Roy F Chemaly, MD, MPH · M.D. Anderson Cancer Center

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-31
Primary Completion
2026-03-31
Completion
2026-05-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03097796 on ClinicalTrials.gov