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

• Status: Completed
• Trial end date: 2019-04-02
• Target enrollment: 0
• Participant gender: All

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)

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: BioAegis Therapeutics Inc.

Criteria

Inclusion Criteria:

1. Informed consent obtained from subject

2. Domicile: home, assisted living, rehabilitation facility, or nursing home (as long as the prospective participant is capable of providing written informed consent)

3. Duration of infection precipitating hospitalization by history <14 days

4. Planned or actual admission to hospital with a primary diagnosis of CAP within 24 hours of presentation to the hospital

5. Primary admitting diagnosis of pneumonia supported by a compatible clinical presentation with a documented infiltrate consistent with pneumonia on chest radiograph or CT, as assessed by the admitting emergency-department (ED), clinic, or ward physician or equivalent caregiver

• Recommended (not mandatory) guidance/discretionary criteria defining patients with CAP:

• At least 2 symptoms: difficulty breathing, cough, production of purulent sputum, chest pain

• At least 2 vital sign abnormalities: fever, tachycardia, tachypnea

• At least one finding of other clinical signs and laboratory abnormalities:

hypoxemia, clinical evidence of pulmonary consolidation, an elevated total white blood cell (WBC) count or leukopenia

• Chest imaging showing new (or presumed new or worsening) infiltrates

• Receipt of antibiotic treatment prior to presentation does not exclude the patient

Exclusion Criteria:

1. Pregnant or lactating women

2. Intubation, vasopressor support, or admission to the intensive care unit (ICU) directly from the ED/office (fluids for responsive hypotension is not a reason for exclusion)

3. Use of any investigational drug in the past 30 days

4. Hospitalization during the last 30 days

5. Residence within the last 30 days in long-term care facility where the patient remains persistently unable to participate in the routine activities of daily living

6. Active underlying cancer treated with systemic chemotherapy or radiation therapy during the last 30 days

7. Known or suspected immunosuppressive disease or therapy (including steroid use equivalent to prednisone ≥20 mg/day for >7 days or known advanced human immunodeficiency virus (HIV) infection with CD4 count ≤200/mm3; specific testing for HIV status or CD4 count is not required but can be done at the discretion of the caregivers)

8. Active congestive heart failure, myocardial infarction, or pulmonary embolism; cardiopulmonary arrest in last 30 days

9. Weight >100 kg

10. Otherwise unsuitable for study participation in the opinion of the investigator