About this trial
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).
Eligibility criteria
Qualifiers
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)
Disqualifiers
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
Trial design
Treatments tested in this trial
- HBI-002
- Vehicle (placebo)
Treatment groups
Sponsors and collaborators
Hillhurst Biopharmaceuticals, Inc.
Lead sponsor
The Parkinson Study Group
Collaborator