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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03466073
Recruitment Status : Completed
First Posted : March 15, 2018
Last Update Posted : May 14, 2019
Sponsor:
Information provided by (Responsible Party):
BioAegis Therapeutics Inc.

Brief 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)

Condition or disease Intervention/treatment Phase
Community-acquired Pneumonia Drug: Recombinant Human Plasma Gelsolin Other: Normal Saline Placebo Phase 1 Phase 2

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 33 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: sequential dose escalation
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: visibly indistinguishable therapy
Primary Purpose: Treatment
Official Title: A Double-blind, Placebo-controlled, Dose-escalation Study of the Safety, Pharmacokinetics, and Pharmacodynamics of Recombinant Human Plasma Gelsolin Added to Standard of Care in Subjects Hospitalized for Acute Community-acquired Pneumonia
Actual Study Start Date : August 3, 2018
Actual Primary Completion Date : March 11, 2019
Actual Study Completion Date : April 2, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia

Arm Intervention/treatment
Experimental: Single Dose 6 mg/kg
Intravenous administration of recombinant human plasma gelsolin at 6 mg/kg v. placebo (NSS) in addition to standard of care
Drug: Recombinant Human Plasma Gelsolin
Recombinant Human Plasma Gelsolin Lyophilized for Reconstitution, reconstituted in sterile water
Other Name: rhu-pGSN

Other: Normal Saline Placebo
Normal saline in volume equivalent to drug
Other Name: NSS (0.9% normal saline)

Experimental: Multiple Dose 6 mg/kg
Intravenous administration of recombinant human plasma gelsolin at 6 mg/kg once per day for 3 days v. placebo (NSS) in addition to standard of care
Drug: Recombinant Human Plasma Gelsolin
Recombinant Human Plasma Gelsolin Lyophilized for Reconstitution, reconstituted in sterile water
Other Name: rhu-pGSN

Other: Normal Saline Placebo
Normal saline in volume equivalent to drug
Other Name: NSS (0.9% normal saline)

Experimental: Multiple Dose 12 mg/kg
Intravenous administration of recombinant human plasma gelsolin at 12 mg/kg once per day for 3 days v. placebo (NSS) in addition to standard of care
Drug: Recombinant Human Plasma Gelsolin
Recombinant Human Plasma Gelsolin Lyophilized for Reconstitution, reconstituted in sterile water
Other Name: rhu-pGSN

Other: Normal Saline Placebo
Normal saline in volume equivalent to drug
Other Name: NSS (0.9% normal saline)

Experimental: Multiple Dose 24 mg/kg
Intravenous administration of recombinant human plasma gelsolin at 24 mg/kg once per day for 3 days v. placebo (NSS) in addition to standard of care
Drug: Recombinant Human Plasma Gelsolin
Recombinant Human Plasma Gelsolin Lyophilized for Reconstitution, reconstituted in sterile water
Other Name: rhu-pGSN

Other: Normal Saline Placebo
Normal saline in volume equivalent to drug
Other Name: NSS (0.9% normal saline)




Primary Outcome Measures :
  1. Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] [ Time Frame: Day 7 ]
    Frequency of SAEs


Secondary Outcome Measures :
  1. Pharmacokinetics (peak levels of rhu-pGSN) [ Time Frame: Days 0-3 ]
    Periodic rhu-pGSN levels during the rhu-pGSN infusion to determine peak plasma concentration (Cmax)

  2. Pharmacokinetics (area under the rhu-pGSN concentration - time curve) [ Time Frame: Days 0-3 ]
    Periodic rhu-pGSN levels during the rhu-pGSN infusion to determine the area under the plasma concentration versus time curve (AUC)


Other Outcome Measures:
  1. Immunogenicity [ Time Frame: Day 28 ]
    Development of antibodies against rhu-pGSN

  2. Surrogate efficacy biomarkers [ Time Frame: Days 0-7 ]
    Circulating cytokine levels (including pGSN, C-reactive protein [CRP], procalcitonin, and 10 ml aliquot of blood to be frozen for subsequent biomarker assays yet to be determined)

  3. Baseline and sequential severity scores [ Time Frame: Days 0-7 ]
    CURB-65 (Confusion, Urea >7 mmol/L, Respiratory rate ≥30/min, Blood pressure systolic <90 or diastolic ≤60, and age ≥65 years: scale 0-5 better to worse, with 3 or more indicating severe



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Informed consent obtained from subject Domicile: home, assisted living, rehabilitation facility, or nursing home (as long as the prospective participant is capable of providing written informed consent) Duration of infection precipitating hospitalization by history <14 days Planned or actual admission to hospital with a primary diagnosis of CAP within 24 hours of presentation to the hospital 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03466073


Locations
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Australia, Queensland
Cairns Hospital
Cairns, Queensland, Australia, 4870
Australia, Victoria
Box Hill Hospital
Box Hill, Victoria, Australia, 3128
Footscray Hospital
Footscray, Victoria, Australia, 3011
Georgia
LTD Geo Hospitals, Mtskheta Multiprofile Medical Center
Mtskheta, Georgia, 3300
JSC Rustavi Central Hospital
Rustavi, Georgia, 3700
LTD Central University Clinic After Academic N. Kipshidze
Tbilisi, Georgia, 0160
LTD S. Khechinashvili University Hospital
Tbilisi, Georgia, 0179
LTD 5th Clinical Hospital
Tbilisi, Georgia, 0191
Sponsors and Collaborators
BioAegis Therapeutics Inc.
Investigators
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Study Chair: Mark J DiNubile, MD BioAegis Therapeutics Inc.

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Responsible Party: BioAegis Therapeutics Inc.
ClinicalTrials.gov Identifier: NCT03466073     History of Changes
Other Study ID Numbers: BTI-201
First Posted: March 15, 2018    Key Record Dates
Last Update Posted: May 14, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by BioAegis Therapeutics Inc.:
recombinant human plasma gelsolin (rhu-pGSN)
severe community-acquired pneumonia (sCAP)
adjunctive therapy
Additional relevant MeSH terms:
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Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections