HBI-002 for Parkinson's (NCT07005180)
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)
- Registry Record Last Updated
- 2026-08-06 (this month)
- Estimated Commitment
- Commitment level unclear from the registry data — ask the study coordinator what taking part involves.
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.
Eligibility at a Glance
Key requirements found in this trial's official criteria, in plain language. Only what the listing states is shown; the study team makes the final call.
- Disease stage: Hoehn and Yahr stage 1 to 3
- Levodopa: Must be taking levodopa (criteria text: "good clinical response to levodopa therapy in the site investigator's opinion 10")
- Medication dose: Must be on a stable dose of Parkinson's medication (criteria text: "for ≥30 days of stable dosing")
- Time since diagnosis: Diagnosed within the last 5 years (criteria text: "diagnosis of pd according to the movement disorder society within 60 months of screening 7")
- Thinking test (MoCA): MoCA memory and thinking score of at least 22 (criteria text: "Signs of dementia (MoCA \< 22)")
Do I Likely Qualify? — Self-Check Dimensions
The trial page offers an interactive self-check built from this trial's parsed criteria. It covers these dimensions; anything the criteria don't state clearly is answered "ask the study coordinator", never assumed.
- This trial enrolls people aged 40 to 80.
- This trial requires participants to be taking levodopa.
- This trial requires a Parkinson's diagnosis within the last 5 years.
- This trial requires Hoehn and Yahr stage 1 to 3.
- This trial requires a MoCA thinking-test score of at least 22.
Locations
- The Parkinson's & Movement Disorder Institute, Fountain Valley, California, United States
- University of Florida, Gainesville, Florida, United States
- Quest Research Institute, Farmington Hills, Michigan, United States
- Weill Cornell Medical College, New York, New York, United States
- Inland Northwest Research, Spokane, Washington, United States
Making Contact: How to Call This Study Site
Who to ask for
Ask for the study coordinator. Some sites call this person the research coordinator. They are the right person for questions about joining a study. If you reach a front desk or a doctor's office scheduler, ask them to connect you with the research team for this study.
What to say
It is fine to read this out loud, word for word:
Hello, my name is ____. I am calling about a Parkinson's study at your site. The study number is NCT07005180. It is the one about "Assess safety of gas medicine". Could I speak with the study coordinator about taking part?
If you are calling for a family member, use their name and mention that you help with their care.
What they will ask you
- The year of diagnosis
- Current medications and their doses
- Other health conditions
- Any procedures already done, such as deep brain stimulation (DBS)
- How far you are able to travel for study visits
- Whether a care partner can come to visits with you
What to have ready
- A written list of current medications and doses
- Your neurologist's name and phone number
- The diagnosis date. The year is enough.
- A recent visit summary from the neurologist, if you have one
What to ask them
- How many visits are there, and how long does each visit take?
- Is travel, parking, or my time reimbursed?
- Is there a placebo group, and what is my chance of being in it? The listing already answers this: This trial has 3 groups, and 1 is a placebo group. Whether you are placed in the placebo group is decided at random. The registry does not tell us how many people go into each group, so ask the coordinator what your chance of being in the placebo group would be.
- Would I need to stop or pause any of my current medications?
- What happens when the study ends? Could I stay on the treatment if it helps?
What to expect
- Expect to wait a few days for a callback. A week is common. Calling or emailing again after that is fine and normal.
- Many callers do not end up joining. Screening out is common and is not a judgment about you or your health.
- Asking questions commits you to nothing. You can stop the process at any point.
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 5 locations.
- Does it cost anything to join?
- Being asked to pay to join a trial is a red flag: legitimate trials do not charge a participation fee, and the study treatment and study-specific tests are provided by the trial sponsor. What you might still pay depends on where you live: in the US, routine care you would receive anyway can be billed to you or your insurance; trials in the UK and Canada usually run through public health systems. Travel, parking, and time are real costs, and some trials reimburse them while others do not. Before enrolling, ask the study coordinator to explain in writing what is and is not covered.
- How long does the trial last?
- This Phase 2 trial is estimated to last approximately 6 months.
- 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.
- 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.
- Will I get a placebo in this trial?
- This trial has 3 groups, and 1 is a placebo group. Whether you are placed in the placebo group is decided at random. The registry does not tell us how many people go into each group, so ask the coordinator what your chance of being in the placebo group would be.