Low-dose Carbon Monoxide (HBI-002) Trial to Evaluate Safety, Tolerability, PK, and Biomarkers in Parkinson's Disease

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age40-80
SponsorHillhurst Biopharmaceuticals, Inc.

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

36 Participants
are divided into 3 treatment groups

Sponsors and collaborators

Hillhurst Biopharmaceuticals, Inc.

Lead sponsor

The Parkinson Study Group

Collaborator