A phase 2a multicenter, randomized, double-blind, placebo-controlled multiple dose study to evaluate the safety, tolerability, pharmacokinetics, of HBI-002, an oral low-dose carbon monoxide (CO) liquid drug product, administered daily over 14 days in subjects with Parkinson's disease (PD).
Signed informed consent.
Male or female 40-80 years of age
Non-smoker for at least 5 years with smoking defined as the use of smoked products (e.g. tobacco, marijuana, vaping or other)
No smoking in the home (i.e. not living with a smoker)
Atypical parkinsonism, including parkinsonism due to drugs, metabolic disorders, encephalitis, cerebrovascular disease, normal pressure hydrocephalus, or other neurodegenerative disease.
Supranuclear gaze palsy
Signs of dementia (MoCA < 22)
History of repeated strokes with stepwise progression of parkinsonian features
Parallel
HBI-002
DrugOral liquid containing carbon monoxide
Vehicle (placebo)
DrugVehicle control (placebo)
Frequency and severity of treatment-emergent AEs related to HBI-002 compared to placebo.
Pharmacokinetics as measured by carboxyhemoglobin (COHb) levels
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Hillhurst Biopharmaceuticals, Inc.
Lead sponsor
The Parkinson Study Group
Collaborator
Massachusetts General Hospital (PI: Michael Schwarzschild MD,PhD, Co-PI: Stephen Gomperts MD,PhD)
Collaborator
Michael J. Fox Foundation for Parkinson's Research
Collaborator
