Back to search results

Low-dose Carbon Monoxide (HBI-002) for Parkinson's Disease

This study is testing a new oral liquid called HBI-002, which contains a very small amount of carbon monoxide (CO), for people with Parkinson's disease. Researchers want to see if HBI-002 is safe and how well your body handles it. They will also look at how much of the drug stays in your system. You might be able to join if you are between 40 and 80 years old and have Parkinson's disease. You must also have been a non-smoker for at least 5 years and not live with a smoker. The main goal is to compare any side effects from HBI-002 to a placebo (an inactive substance) to understand its safety.

Study design
This is a Phase 2a study involving 36 participants. It is a randomized, double-blind, placebo-controlled study, meaning participants are randomly assigned to receive either HBI-002 or a placebo, and neither you nor your doctor will know which you are receiving.
What's involved
Participants will take the study drug (HBI-002 or placebo) daily for 14 days.
Compensation
Not stated in the trial record.
Follow-up
Your safety will be monitored from the start of treatment until 30 days after the end of treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07005180

Low-dose Carbon Monoxide (HBI-002) Trial to Evaluate Safety, Tolerability, PK, and Biomarkers in Parkinson's Disease

Recruiting
PHASE2Ages 40–80InterventionalTreatment
Hillhurst Biopharmaceuticals, Inc.
~36 participants
Updated 2026-08-10 on ClinicalTrials.gov
What's tested:HBI-002Vehicle (placebo)

At a glance

Recruiting sites
5 of 5 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Frequency and severity of treatment-emergent AEs related to HBI-002 compared to placebo.
Measured over From treatment to 30 days after the end of treatment

Conditions

Parkinson Disease

Explore related trials

Parkinson Disease

NCT07005180

Where you'd take part

This study runs at 5 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Inland Northwest Research

    Spokane, Washingtonstudy coordinator listed

    Recruiting

  • Quest Research Institute

    Farmington Hills, Michiganstudy coordinator listed

    Recruiting

  • The Parkinson's & Movement Disorder Institute

    Fountain Valley, Californiastudy coordinator listed

    Recruiting

  • University of Florida

    Gainesville, Floridastudy coordinator listed

    Recruiting

  • Weill Cornell Medical College

    New York, New Yorkstudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Who to contact

President and CEO
[email protected]
858-232-9495
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Want this trial checked against your situation?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Exclusion

History of angina pectoris
History of myocardial infarction or cardiac failure (NYHA from II to IV), myocardial insufficiency, symptomatic congestive heart failure with a documented ejection fraction below 45%
History of serious cardiac arrhythmia other than stable atrial fibrillation
History of stroke or occlusive peripheral vascular disease, brain vasospasm 2. Structural brain disease or cerebrovascular disease with clinical significance, including intracranial space-occupying lesion 3. Severe uncontrolled arterial hypertension 4. Severe pulmonary disease (asthma, COPD, other) 5. Specific psychiatric disorders, including hallucinations, delusions, pathologic gambling, alcohol or substance abuse or dependence 6. Type 1 or type 2 diabetes mellitus, impaired glucose tolerance, metabolic syndrome, maturity onset diabetes of the young, and gestational diabetes. 7. Pulmonary infiltrate or pneumonia within 6 months before screening or acute infection within 14 days of screening 8. Seizures / epilepsy 9. Autoimmune disease requiring prescribed immunomodulatory therapy 9. Alcohol abuse or dependence within one year prior to screening or regular use of alcohol within six months prior to the screening visit (defined as more than 14 units of alcohol per week; 1 Unit = 150 mL wine, 360 mL beer or 45 mL of 40% alcohol) 10. History of drug abuse or dependence 11. Positive result on drug screen for THC, cocaine, opiates/opioids, and methamphetamine 12. History of cancer, with the exception of adequately treated basal cell or squamous cell carcinoma of the skin more than 3 months prior 13. Subject on domiciliary oxygen 14. Positive HBsAg, aHCV, or aHIV 15. Positive SARS-CoV-2 test within 10 days prior to study drug treatment 16. Weight loss or gain of more than 5 kg within 3 months of screening 17. Febrile or infective illness within 10 days prior to study drug treatment 18. Moderate or more severe depression (Geriatric Depression Scale (GDS) ≥9) 19. Suicide attempt or suicidal ideation within five years (Columbia-Suicide Severity Rating Scale (C-SSRS) defined as answering yes to items 4 or 5 on the C-SSRS, or history of suicide attempt in previous 5 years, or, in the Investigator's opinion, at serious risk of suicide. 20. Positive pregnancy test or breast feeding for females 21. Treatment with an investigational drug or medical device within the longer of 60 days or ten half-lives of the investigational agent 22. Simultaneous participation or previous participation within 60 days before screening in another clinical drug or medical device study 23. Persisting anemia with hemoglobin \<9 g/dL 24. Blood transfusion within 42 days prior to the first administration of study drug 25. Exposure to any live vaccine within 28 days prior to study drug administration 26. Syncope or other cause of loss of consciousness within the last 2 years 27. Unwilling or unable to respond to follow-up phone calls 28. Unwilling or unable to communicate with study site staff by telephone 29. Unwilling or unable to comply with the requirements of the protocol 30. Any coincident disease or condition that in the opinion of the Site Investigator will confound the assessment of HBI-002 safety or efficacy 31. Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the Site Investigator, would make the subject inappropriate for entry into the study 32. History of allergic reactions to any of the drug product excipients 33. Contraindications to a routine lumbar puncture

What this trial measures

  • Frequency and severity of treatment-emergent AEs related to HBI-002 compared to placebo.From treatment to 30 days after the end of treatment