Overview
This study is testing the safety and short-term effects of HBI-002 in people with Parkinson's. There is evidence that low blood levels of carbon monoxide produced by smoking cigarettes may help explain why smokers are less likely to get Parkinson's, and may benefit people with Parkinson's without subjecting them to the known health risks of smoking. HBI-002 is an oral liquid drug product containing carbon monoxide. The study includes about 2 weeks of dosing and in total will last around 7-10 weeks including 4 weeks of follow up. To participate, you must have a care partner who can visit the study site with you and observe you fo rat least 4 hours after taking the study drug at home. All expenses related to the study will be reimbursed. You will receive a small stipend for each study visit. A care partner will also receive a small stipend for some study visits.
Description
HBI-002 has previously been tested for safety in 20 healthy adults. Now, HBI-002 is being tested in people with Parkinson's. About 36 people with Parkinson's will participate.
Participants will be assigned to one of three treatment groups. 12 participants will receive a placebo, an inactive substance to compare the drug to. 12 participants will receive a lower dose of HBI-002, and 12 participants will receive a higher dose of HBI-002. You will take the study drug in the form of a liquid drink once daily for 14 days. You will receive your first three doses of the drug at the study site. You will also receive doses on Days 7 and 14 at the study site. The rest of the doses are taken at home with a care partner.
Before starting and after you complete the study drug, you will undergo a standard lumbar puncture to collect spinal fluid for testing. This is important in assessing biomarkers of Parkinson's disease so we can better understand the biology of this therapy in Parkinson's disease. Other samples like blood and urine will also be collected throughout the study.
Eligibility
You may be considered for the study if you:
- Are 40-80 years old
- Have a diagnosis of mild to moderate Parkinson's and have been on Parkinson's medication (e.g., levodopa or other antiparkinsonian medication) for at least 30 days
- Have not smoked for at least 5 years (including tobacco, marijuana, vaping, or other)
You may not be able to take part if you:
- Have atypical parkinsonism or a history of other cerebral health issues (e.g., dementia, repeated strokes, repeated head injuries)
- Have a history of serious cardiovascular diseases
- Have Type 1 or Type 2 diabetes
- Have a history of substance misuse or dependence (including alcohol, THC, opiates/opioids, etc.)
- Have participated in another clinical drug or medical device study within 60 days of screening