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A Phase 1b/2a Study of the Safety and Pharmacokinetics of Rhu-plasma Gelsolin in Hospitalized Subjects With CAP

NCT03466073 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 33

Last updated 2020-01-27

Study results available
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Summary

A Phase 1b/2a, Double-blind, Placebo-controlled, Dose-escalation Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of Recombinant Human Plasma gelsolin (rhu-pGSN) Added to Standard of Care in Subjects Hospitalized for Acute Community-acquired Pneumonia (CAP)

Conditions

  • Community-acquired Pneumonia

Interventions

DRUG

Recombinant Human Plasma Gelsolin

Recombinant human plasma gelsolin lyophilized for reconstitution, reconstituted in sterile water

OTHER

Normal Saline Placebo

Normal saline in volume equivalent to drug

Sponsors & Collaborators

  • BioAegis Therapeutics Inc.

    lead INDUSTRY

Principal Investigators

  • Mark J DiNubile, MD · BioAegis Therapeutics Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-08-28
Primary Completion
2019-04-02
Completion
2019-04-02

Countries

  • Australia
  • Georgia

Study Locations

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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 NCT03466073 on ClinicalTrials.gov