NCT06665100

PUL-042 Treatment in Patients With Parainfluenza Virus (PIV), Human Metapneumovirus (hMPV) or Respiratory Syncytial Virus (RSV)

Efficacy and Safety of PUL-042 Inhalation Solution in Reducing Lower Respiratory Tract Complications in Patients With Hematologic Malignancies and Recipients of Hematopoietic Stem Cell Transplantation (HSCT) With Documented Viral Infections With PIV, hMPV or RSV

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Pulmotect, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this research study is to try to see whether an experimental drug, PUL 042 Inhalation Solution (PUL 042), is effective in reducing the severity of lung infections in patients with hematologic malignancies and recipients of hematopoietic stem cell transplantation with documented viral infections due to PIV, hMPV, or RSV. PUL-042 or a placebo will be administered 3 times over a 6-day period. The total duration of the study will be approximately 30 days.

Detailed description

A total of up to 100 participants will be enrolled in this research study, at up to 15 centers. Participants in the study will receive either PUL-042 or a placebo (an inactive agent that appears identical to PUL-042). Patients will be randomized 1:1 for PUL-042 or placebo. The first 50 patients will either be low dose PUL-042 or placebo. After review of the safety data from the initial patients, the PUL-042 dose may be increased. Subjects will be evaluated by chest x-ray and clinical status for respiratory complications.

Conditions

• Hematologic Malignancies
• Hematopoietic Stem Cell Transplant (HSCT)

Interventions

Type	Name	Description
DRUG	PUL-042	Pam2 : ODN (PUL-042) PUL-042 Inhalation Solution
DRUG	Placebo	Sterile Saline for Inhalation

Timeline

• Start date: 2025-06-27
• Primary completion: 2026-04-01
• Completion: 2026-05-01
• First posted: 2024-10-30
• Last updated: 2025-09-15

Locations

11 sites across 1 country: United States

Regulatory

• FDA-regulated drug study