Assess safety of gas medicine
- Trial ID
- NCT07005180
- Official Title
- 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)
- Goal
- Assess safety of gas medicine
- Phase
- PHASE2
- Status
- RECRUITING
- Sponsor
- Hillhurst Biopharmaceuticals, Inc.
- Study Type
- INTERVENTIONAL
- Enrollment
- 36 participants
- Conditions
- Parkinson Disease
- Interventions
- HBI-002, Vehicle (placebo)
Summary For Families
The goal is to see if short, daily doses of very low‑dose oral carbon monoxide can be given safely and are tolerable in people with Parkinson's, while collecting early drug level data and looking at effects on inflammation and oxidative stress that may harm brain cells. HBI-002 is a liquid that delivers tiny amounts of carbon monoxide, a naturally occurring signaling gas that can reduce inflammation and oxidative stress and support cellular protective pathways, and it is taken for 14 days alongside participants' usual Parkinson's medications with careful monitoring for safety and any interactions with levodopa. The trial is looking for non-smoking adults aged 40 to 80 with a Parkinson's diagnosis within the past five years, Hoehn and Yahr stage 3 or lower, a good clinical response on stable levodopa (at least 100 mg three times daily or equivalent), who meet lab and weight limits and can have a study partner to observe them after dosing.
Locations
- Quest Research Institute, Farmington Hills, Michigan, United States
Frequently Asked Questions
- What is this trial testing?
- This trial is studying HBI-002. The goal is to see if short, daily doses of very low‑dose oral carbon monoxide can be given safely and are tolerable in people with Parkinson's, while collecting early drug level data and looking at effects on inflammation and oxidative stress that may harm brain cells. HBI-002 is a liquid that delivers tiny amounts of carbon monoxide, a naturally occurring signaling gas that can reduce inflammation and oxidative stress and support cellular protective pathways, and it is taken for 14 days alongside participants' usual Parkinson's medications with careful monitoring for safety and any interactions with levodopa. The trial is looking for non-smoking adults aged 40 to 80 with a Parkinson's diagnosis within the past five years, Hoehn and Yahr stage 3 or lower, a good clinical response on stable levodopa (at least 100 mg three times daily or equivalent), who meet lab and weight limits and can have a study partner to observe them after dosing.
- Who can participate?
- Participants must be between 40 Years and 80 Years.
- Where is this trial located?
- This trial is recruiting at 1 location.
- Does it cost anything to join?
- No. There is no cost to participate. Study-related care and treatment are provided at no charge.
- How long does the trial last?
- This Phase 2 trial is estimated to last approximately 8 months.
- Will I get the real drug or a placebo?
- It depends on the trial design. Some Parkinson's trials are placebo controlled, meaning a portion of participants get an inactive comparison while others get the experimental treatment. Some use crossover designs so everyone eventually receives the active treatment at some point. Observational trials do not use a placebo at all because they are not testing a new treatment. The consent form for any specific trial spells out the design and your odds of being assigned to placebo before you enroll.
- How often will I need to visit the study site?
- Visit frequency varies by trial. Many Parkinson's studies require an in person visit every 4 to 12 weeks during the active treatment phase, with shorter or longer gaps depending on the design. The site coordinator can give you the full visit schedule before you sign anything, so you know what the time commitment looks like.
- Can I leave the trial if I change my mind?
- Yes. You can withdraw from any clinical trial at any time, for any reason, without affecting your standard medical care. Trials are voluntary by law. The team may ask if you are willing to do a brief exit visit so they can collect safety information, but you are not obligated.
- Will travel or parking be reimbursed?
- Many trials reimburse for parking, mileage, and sometimes lodging if the site is far from your home. Reimbursement policies vary by sponsor and site. When you contact the trial team, ask specifically what is covered and how reimbursement is processed.
- Can my spouse or care partner come with me to visits?
- In most cases yes, and it is often encouraged. Care partners can help with notes, questions, and getting home safely after a long visit. Some study assessments do need to happen one on one, but care partners are usually welcome for the rest of the appointment.