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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
Results First Posted : January 27, 2020
Last Update Posted : January 27, 2020
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

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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 28, 2018
Actual Primary Completion Date : April 2, 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. Number of Participants With Treatment-Emergent Adverse Events (TEAEs) [ Time Frame: 0-28 days ]
    Treatment emergent adverse events were all adverse events (AEs) that occurred subsequent to enrollment. The seriousness of adverse events was judged by the site investigator.


Secondary Outcome Measures :
  1. Pharmacokinetics (PK) (Area Under the Rhu-pGSN Concentration - Time Curve) [ Time Frame: On Days 0-3, specimens were obtained just prior and immediately post dose and 2, 8,12 and/or 16 , and 24 hours post completion of IV administration. In the single-dose arm, only 1 dose was given and thus no data from later days were obtained. ]
    Determine AUC 0-t area under the plasma concentration-time curve of rhu-pGSN from 0-24 hours on dosing days (estimated by subtracting pre-injection concentrations from the measured concentrations at each time point). In the single-dose arm, the subject was given only 1 dose so that data from later days were not obtained. In the multiple-dose arms, samples were obtained for each of the 3 doses.

  2. Pharmacokinetics (PK) (Maximum Observed Rhu-pGSN Plasma Concentration (Cmax)) [ Time Frame: On Days 0-3, specimens were obtained just prior and immediately post dose and 2, 8, 12 and/or 16, and 24 hours post completion of IV administration. In the single-dose arm, only 1 dose was given and thus no data from later days were obtained. ]
    Maximum observed plasma concentration (Cmax) of rhu-pGSN in a 24 hours period after intravenous administration (estimated by subtracting pre-injection concentrations from the measured concentrations at each time point). For the 6 mg/kg dose, there were 4 evaluable subjects in the single-dose arm and 6 subjects in the multiple-dose arm at this dose, for a total of 10 evaluable subjects for Dose 1.


Other Outcome Measures:
  1. Number of Participants With Anti-pGSN Antibodies (Immunogenicity) at the End of Study (Day 28) [ Time Frame: Day 28 ]
    Number of participants who developed antibodies against pGSN at study day 28. Patients were first tested against less stringent screening criteria: if screen-positive, a stricter confirmatory test was performed; if screen-negative, no further immunogenicity testing was done.

  2. Baseline and Sequential Severity Scores [ Time Frame: Days 0-28 ]
    CURB-65 (a 5 point score in which 1 point is allocated to the presence of each of the following: Confusion, Urea >7 mmol/L, Respiratory rate ≥30 breaths min, Blood pressure systolic <90 mmHg or diastolic ≤60 mmHg, and age ≥65 years); PSI (Pneumonia Severity Index, used to predict risk of morbidity and mortality and is classified in risk classes ranging from I to V from the lowest to highest risk as follows: Class I: PSI 0, class II: PSI 1-70, class III: PSI 71-90, class IV: PSI 91-130, class V: PSI >130); SOFA (Sequential Organ Failure Assessment, measured based on 6 variables each representing an organ system scored from 0 to 4 each (normal to severe organ dysfunction/failure), and reported as the sum (range 0-24))



Information from the National Library of Medicine

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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:

  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

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.
  Study Documents (Full-Text)

Documents provided by BioAegis Therapeutics Inc.:
Study Protocol  [PDF] April 30, 2018
Statistical Analysis Plan  [PDF] December 3, 2018

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Responsible Party: BioAegis Therapeutics Inc.
ClinicalTrials.gov Identifier: NCT03466073    
Other Study ID Numbers: BTI-201
First Posted: March 15, 2018    Key Record Dates
Results First Posted: January 27, 2020
Last Update Posted: January 27, 2020
Last Verified: January 2020

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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