Parkinson DiseasePhase 2LoCaMoTE-PDNCT07005180
Low-dose Carbon Monoxide (HBI-002) Trial to Evaluate Safety, Tolerability, PK, and Biomarkers in Parkinson's Disease
A Phase 2 study testing HBI-002 in people with Parkinson Disease, run by Hillhurst Biopharmaceuticals, Inc. at 8 sites in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- HBI-002
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 8 sitesUnited States
- Study dates
- 30 Jun 2026to 31 Mar 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects must meet the following criteria before being enrolled into the study:
- Signed informed consent.
- Male or female 40-80 years of age
- Non-smoker for at least 5 years with smoking defined as the use of smoked products (e.g. tobacco, marijuana, vaping or other)
- No smoking in the home (i.e. not living with a smoker)
- Body weight between 60 kg and 110 kg (inclusive) and with BMI less than 30 kg/m2 at screening and baseline
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- Diagnosis of PD according to the Movement Disorder Society within 60 months of screening
- Hoehn and Yahr stage ≤ 3
- PD therapy: use of ≥100 mg TID levodopa or equivalent dose with additional carbidopa/levodopa or other antiparkinsonian medication (e.g. dopamine agonists [e.g., pramipexole, ropinirole, rotigotine] and monoamine oxidase inhibitors [e.g., selegiline or rasagiline]) for ≥30 days of stable dosing
- Good clinical response to levodopa therapy in the Site Investigator's opinion
- Negative pregnancy test for females of childbearing potential
- Where appropriate, subjects must be willing to use a highly effective method of contraception for the duration of the study and for 45 days thereafter
- Male subjects, without a vasectomy, whose partner is of childbearing potential, must use a condom and be instructed that their female partner should use another form of contraception such as an IUD, diaphragm with spermicide, oral contraceptive, injectable progesterone, subdermal implant or a tubal ligation. Male subjects are prohibited from donating sperm for the duration of the study and 60 days following the end of study visit.
- Female subjects of childbearing potential (not surgically sterilized and less than one year post-menopausal) should use a medically accepted form of contraception such as an IUD, diaphragm with spermicide, oral contraceptive, injectable progesterone, subdermal implant or a tubal ligation, and be instructed that their male partners should use a condom, if not vasectomized.
- Subjects must be healthy as defined by the following.
- liver function: alanine transaminase (ALT) and aspartate transaminase (AST) ≤ 2X ULN
- total bilirubin ≤ 1.5X ULN
- renal function: creatinine clearance within normal range as assessed by Cockcroft and Gault calculation
- carboxyhemoglobin level by venous blood gas ≤ 3.5%
- the absence of current clinically relevant abnormalities identified by a detailed medical history, full physical examination including blood pressure, pulse rate, and respiratory rate measurement, 12-lead ECG, and clinical laboratory tests (hematology and clinical chemistries), as determined by the Site Investigator.
- HbA1c < 6.5%
- Subjects must have a study partner who can observe the subject for at least 4 hours after dosing at home (non-clinic days) in order to monitor for indications of CO toxicity.
- Subjects should live within 100 miles driving distance (door to door) of the site/clinic due to the need to carry study drug and ship study drug between the site/clinic and subject's home. Exceptions to this may be considered with Sponsor approval if it can be assured that the subject can transport study drug from clinic to home within two hours.
Who cannot join
- Subjects who meet any of the following criteria will be ineligible for participation in the study:
- Clinical signs indicating a parkinsonian syndrome other than idiopathic PD, specifically:
- Atypical parkinsonism, including parkinsonism due to drugs, metabolic disorders, encephalitis, cerebrovascular disease, normal pressure hydrocephalus, or other neurodegenerative disease.
- Supranuclear gaze palsy
- Signs of dementia (MoCA < 22)
- History of repeated strokes with stepwise progression of parkinsonian features
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- History of repeated head injury
- History of definite encephalitis
- Cerebellar signs
- Early severe autonomic involvement
- Babinski sign present
- Dysphagia with liquids
- History of exposure to or current treatment with neuroleptic drugs.
- History of dementia
- Oxygen saturation by transcutaneous measurement ≤ 95% confirmed on repeat assessment (any time prior to the first dose)
- Clinically significant ECG abnormalities (prolonged QTc greater than normal range, arrhythmia detected, bradycardia <45 bpm, tachycardia >120 bpm, AV block [second or greater degree], bundle branch block) or vital sign abnormalities (systolic blood pressure lower than 90 or above 140 mm Hg, diastolic blood pressure lower than 50 or above 90 mm Hg, or heart rate less than 45 or above 100 bpm or arrhythmia), as determined by the Site Investigator.
- Renal failure requiring renal replacement therapy
- History of:
- Serious cardiovascular diseases
- 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
- Structural brain disease or cerebrovascular disease with clinical significance, including intracranial space-occupying lesion
- Severe uncontrolled arterial hypertension
- Severe pulmonary disease (asthma, COPD, other)
- Specific psychiatric disorders, including hallucinations, delusions, pathologic gambling, alcohol or substance abuse or dependence
- Type 1 or type 2 diabetes mellitus, impaired glucose tolerance, metabolic syndrome, maturity onset diabetes of the young, and gestational diabetes.
- Pulmonary infiltrate or pneumonia within 6 months before screening or acute infection within 14 days of screening
- Seizures / epilepsy
- Autoimmune disease requiring prescribed immunomodulatory therapy
- 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)
- History of drug abuse or dependence
- Positive result on drug screen for THC, cocaine, opiates/opioids, and methamphetamine
- History of cancer, with the exception of adequately treated basal cell or squamous cell carcinoma of the skin more than 3 months prior
- Subject on domiciliary oxygen
- Positive HBsAg, aHCV, or aHIV
- Positive SARS-CoV-2 test within 10 days prior to study drug treatment
- Weight loss or gain of more than 5 kg within 3 months of screening
- Febrile or infective illness within 10 days prior to study drug treatment
- Moderate or more severe depression (Geriatric Depression Scale (GDS) ≥9)
- 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.
- Positive pregnancy test or breast feeding for females
- Treatment with an investigational drug or medical device within the longer of 60 days or ten half-lives of the investigational agent
- Simultaneous participation or previous participation within 60 days before screening in another clinical drug or medical device study
- Persisting anemia with hemoglobin <9 g/dL
- Blood transfusion within 42 days prior to the first administration of study drug
- Exposure to any live vaccine within 28 days prior to study drug administration
- Syncope or other cause of loss of consciousness within the last 2 years
- Unwilling or unable to respond to follow-up phone calls
- Unwilling or unable to communicate with study site staff by telephone
- Unwilling or unable to comply with the requirements of the protocol
- Any coincident disease or condition that in the opinion of the Site Investigator will confound the assessment of HBI-002 safety or efficacy
- 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
- History of allergic reactions to any of the drug product excipients
- Contraindications to a routine lumbar puncture
- History of thrombocytopenia (platelet count <100,000)
- History of coagulopathy (INR >1.3, PTT >ULN)
- Current use of warfarin or other anticoagulants, or clopidogrel (Plavix)
- History of lumbar surgery or severe spinal arthritis
- Infection at LP site (may be included once resolved)
Trial locations and contacts
8 sites in 1 country. Contact the study team or a site near you to ask about taking part.
8 sites in 1 country
United States8 sites, 8 recruiting
- Not yet recruiting
University of Michigan
Ann Arbor, Michigan, 48105
Gerianne Que, queg@med.umich.edu
- Not yet recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02114
Grace Bwala, gbwala@mgh.harvard.edu
- Not yet recruiting
Michigan State University
East Lansing, Michigan, 48823
Aubrey Alexander, alexaub@msu.edu
- Recruiting
Quest Research Institute
Farmington Hills, Michigan, 48334
Tamsin Andres, tamsin.andres@questri.com
- Recruiting
The Parkinson's & Movement Disorder Institute
Fountain Valley, California, 92708
Emily Nguyen, enguyen@pmdi.org
- Recruiting
University of Florida
Gainesville, Florida, 32608
Camille Swartz, Cami.Swartz@neurology.ufl.edu
- Recruiting
Weill Cornell Medical College
New York, New York, 10021
Charles Snajdr-Trinch, chs4056@med.cornell.edu
- Recruiting
Inland Northwest Research
Spokane, Washington, 99202
Lindsey Strom, Contact@inwresearch.com
About this study
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)
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
- Parkinson Disease
- Being tested
- HBI-002, Vehicle (placebo)
- Keywords
- Parkinson Disease, HBI-002, low dose carbon monoxide, heme oxygenase, HO-1, Nrf2, HIF-1α
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HBI-002Drug
Oral liquid containing carbon monoxide
Vehicle (placebo)Drug
Vehicle control (placebo)
| Study group | Role | What they receive |
|---|---|---|
| High Dose | Experimental | Not described Receives: Drug: HBI-002 |
| Low Dose | Experimental | Not described Receives: Drug: HBI-002 |
| Placebo | Placebo comparator | Not described Receives: Drug: Vehicle (placebo) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency and severity of treatment-emergent AEs related to HBI-002 compared to placebo.
Measured: From treatment to 30 days after the end of treatment
Secondary outcomes (1)
Pharmacokinetics as measured by carboxyhemoglobin (COHb) levels
Measured: Days 1 and 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2025
- Study start30 Jun 2026
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hillhurst Biopharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- The Parkinson Study Group, Massachusetts General Hospital (PI: Michael Schwarzschild MD,PhD, Co-PI: Stephen Gomperts MD,PhD), Michael J. Fox Foundation for Parkinson's Research
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07005180
- Sponsor's protocol ID
- HBI-002-221
- Acronym
- LoCaMoTE-PD
- Status last verified
- Aug 2026
- First submitted
- 28 Feb 2025
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT07005180
- Acronym / sponsor ID
- LoCaMoTE-PD / HBI-002-221
- Conditions
- Parkinson Disease
- Keywords
- Parkinson Disease, HBI-002, low dose carbon monoxide, heme oxygenase, HO-1, Nrf2, HIF-1α
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Hillhurst Biopharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Collaborators
- The Parkinson Study Group, Massachusetts General Hospital (PI: Michael Schwarzschild MD,PhD, Co-PI: Stephen Gomperts MD,PhD), Michael J. Fox Foundation for Parkinson's Research
- Study start
- 30 Jun 2026 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 5 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| High Dose | Experimental | Drug: HBI-002 |
| Low Dose | Experimental | Drug: HBI-002 |
| Placebo | Placebo comparator | Drug: Vehicle (placebo) |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (23 listed)
- Signed informed consent.
- Male or female 40-80 years of age
- Non-smoker for at least 5 years with smoking defined as the use of smoked products (e.g. tobacco, marijuana, vaping or other)
- No smoking in the home (i.e. not living with a smoker)
- Body weight between 60 kg and 110 kg (inclusive) and with BMI less than 30 kg/m2 at screening and baseline
Key exclusion criteria (61 listed)
- Subjects who meet any of the following criteria will be ineligible for participation in the study:
- Clinical signs indicating a parkinsonian syndrome other than idiopathic PD, specifically:
- Dysphagia with liquids
- History of exposure to or current treatment with neuroleptic drugs.
- History of dementia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HBI-002Oral liquid containing carbon monoxide | Drug | High Dose, Low Dose |
| Vehicle (placebo)Vehicle control (placebo) | Drug | Placebo |
Primary outcome
Frequency and severity of treatment-emergent AEs related to HBI-002 compared to placebo.
Time frame: From treatment to 30 days after the end of treatment
1 secondary outcome
Pharmacokinetics as measured by carboxyhemoglobin (COHb) levels
Time frame: Days 1 and 14
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing HBI-002 in people with Parkinson Disease, run by Hillhurst Biopharmaceuticals, Inc. at 8 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 23 inclusion and 61 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact President and CEO (858-232-9495, hillhurstinfo@hillhurstbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency and severity of treatment-emergent AEs related to HBI-002 compared to placebo. (time frame: From treatment to 30 days after the end of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2026.