Actively Recruiting
Low-dose Carbon Monoxide (HBI-002) Trial to Evaluate Safety, Tolerability, PK, and Biomarkers in Parkinson's Disease
Led by Hillhurst Biopharmaceuticals, Inc. · Updated on 2026-05-11
36
Participants Needed
1
Research Sites
45 weeks
Total Duration
On this page
Sponsors
H
Hillhurst Biopharmaceuticals, Inc.
Lead Sponsor
T
The Parkinson Study Group
Collaborating Sponsor
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
Low-dose Carbon Monoxide (HBI-002) Trial to Evaluate Safety, Tolerability, PK, and Biomarkers in Parkinson's Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent.
- Male or female aged 40 to 80 years.
- Non-smoker for at least 5 years and no smoking in the home.
- Body weight between 60 kg and 110 kg with BMI less than 30 kg/m2.
- Diagnosed with Parkinson's disease within 60 months of screening.
- Hoehn and Yahr stage less than or equal to 3.
- Stable Parkinson's therapy with at least 100 mg TID levodopa or equivalent for at least 30 days.
- Good clinical response to levodopa therapy as judged by the investigator.
- Negative pregnancy test for females of childbearing potential.
- Willingness to use effective contraception during and for 45 days after the study.
- Healthy as defined by liver and kidney function tests, carboxyhemoglobin level ≤3.5%, and absence of relevant abnormalities.
- Have a study partner to observe for carbon monoxide toxicity for at least 4 hours after dosing at home.
- Live within 100 miles driving distance of the study site or can transport study drug within two hours if farther away.
You will not qualify if you...
- Parkinsonian syndromes other than idiopathic Parkinson's disease, including atypical forms and related neurological conditions.
- Dementia or MoCA score less than 22.
- History of repeated strokes, head injury, encephalitis, cerebellar signs, severe autonomic involvement, or Babinski sign.
- Dysphagia with liquids.
- Current or past treatment with neuroleptic drugs.
- Oxygen saturation less than or equal to 95%.
- Significant ECG or vital sign abnormalities.
- Renal failure requiring replacement therapy.
- History of serious cardiovascular diseases, structural brain disease, uncontrolled hypertension, severe pulmonary disease, or certain psychiatric disorders.
- Diabetes or metabolic syndromes.
- Recent pulmonary infection or acute infection.
- Seizures, autoimmune disease requiring immunomodulation.
- Alcohol or drug abuse history.
- Positive drug screens for certain substances.
- History of cancer except treated skin carcinoma.
- Use of domiciliary oxygen.
- Positive tests for hepatitis B, hepatitis C, HIV, or recent COVID-19.
- Significant recent weight changes or infections.
- Moderate or severe depression or recent suicidal risk.
- Positive pregnancy test or breastfeeding.
- Recent participation in other investigational studies.
- Anemia or recent blood transfusion.
- Recent live vaccine exposure.
- Recent syncope or loss of consciousness.
- Unwillingness or inability to comply with study procedures.
- Any condition that may interfere with safety or study results.
- Allergic reactions to study drug excipients.
- Contraindications to lumbar puncture including clotting or spinal issues.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Quest Research Institute
Farmington Hills, Michigan, United States, 48334
Actively Recruiting
Research Team
P
President and CEO
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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