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)
Hillhurst Biopharmaceuticals, Inc.
Summary
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
- Age range
- 40–80 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: Subjects must meet the following criteria before being enrolled into the study: 1. Signed informed consent. 2. Male or female 40-80 years of age 3. Non-smoker for at least 5 years with smoking defined as the use of smoked products (e.g. tobacco, marijuana, vaping or other) 4. No smoking in the home (i.e. not living with a smoker) 5. Body weight between 60 kg and 110 kg (inclusive) and with BMI less than 30 kg/m2 at screening and baseline 6. Diagnosis of PD according to the Movement Disorder Society within 60 months of screening 7. Hoehn and Yahr stage ≤ 3 8. PD therapy: u…
Interventions
- DrugHBI-002
Oral liquid containing carbon monoxide
- DrugVehicle (placebo)
Vehicle control (placebo)
Location
- Quest Research InstituteFarmington Hills, Michigan