Phase 2
N=33
A Phase 1b/2a Study of the Safety and Pharmacokinetics of Rhu-plasma Gelsolin in Hospitalized Subjects With CAP
Community-acquired Pneumonia
Bottom Line
View on ClinicalTrials.gov: NCT03466073 ↗Enrolled (actual)
33
Serious AEs
6.1%
Results posted
Jan 2020
Primary outcome: Primary: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) — 4; 2; 4; 3 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Recombinant Human Plasma Gelsolin (Drug); Normal Saline Placebo (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- BioAegis Therapeutics Inc.
- Primary completion
- Apr 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Treatment-Emergent Adverse Events (TEAEs) |
4; 2; 4; 3; 2; 4 | — |
| SECONDARY Pharmacokinetics (PK) (Area Under the Rhu-pGSN Concentration - Time Curve) |
984.4; 3450.1; 6911.3; 674.3; 2602.8; 1818.4 | — |
| SECONDARY Pharmacokinetics (PK) (Maximum Observed Rhu-pGSN Plasma Concentration (Cmax)) |
226.6; 291.9; 533.9; 177.9; 292.0; 347.3 | — |
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)
Eligibility 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 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)
- Active congestive heart failure, myocardial infarction, or pulmonary embolism; cardiopulmonary arrest in last 30 days
- Weight >100 kg
- Otherwise unsuitable for study participation in the opinion of the investigator
Data sourced from ClinicalTrials.gov (NCT03466073). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.