Low-dose Carbon Monoxide (HBI-002) Trial to Evaluate Safety, Tolerability, PK, and Biomarkers in … (NCT07005180) | Clinical Trial Compass
RecruitingPhase 2
Low-dose Carbon Monoxide (HBI-002) Trial to Evaluate Safety, Tolerability, PK, and Biomarkers in Parkinson's Disease
United States36 participantsStarted 2026-05-15
Plain-language 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).
Who can participate
Age range40 Years – 80 Years
SexALL
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Inclusion criteria
✓. 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)
✓. Body weight between 60 kg and 110 kg (inclusive) and with BMI less than 30 kg/m2 at screening and baseline
✓. Diagnosis of PD according to the Movement Disorder Society within 60 months of screening
✓. Hoehn and Yahr stage ≤ 3
✓. PD therapy: use of ≥100 mg TID levodopa or equivalent dose with additional carbidopa/levodopa or other antiparkinsonian medication (e.g. dopamine agonists \[e.g., pramipexole, ropinirole, rotigotine\] and monoamine oxidase inhibitors \[e.g., selegiline or rasagiline\]) for ≥30 days of stable dosing
Exclusion criteria
✕. Clinical signs indicating a parkinsonian syndrome other than idiopathic PD, specifically:
✕. 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)
What they're measuring
1
Frequency and severity of treatment-emergent AEs related to HBI-002 compared to placebo.
Timeframe: From treatment to 30 days after the end of treatment