Trial studying safety and effects for Parkinson Disease
Official title Low-dose Carbon Monoxide (HBI-002) Trial to Evaluate Safety, Tolerability, PK, and Biomarkers in Parkinson's Disease
ClinicalTrials.gov ID: NCT07005180
What this study is testing
What is HBI-002?
HBI-002 is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for parkinson disease.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 40 to 80
You may be able to join if
- people 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)
You likely can't join if
- people 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...
- Supranuclear gaze palsy
- Signs of dementia (MoCA \< 22)
- History of repeated strokes with stepwise progression of parkinsonian features
See the full eligibility criteria
Who can join
- people 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
- 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...
- Good clinical response to levodopa therapy in the Site Investigator's opinion
- Negative pregnancy test for females of childbearing potential
- Where appropriate, people must be willing to use a highly effective method of contraception for the duration of the study and for 45 days thereafter
- Male people, 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...
- Female people 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...
- people 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...
- HbA1c \< 6.5%
- people 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.
- people 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...
What rules you out
- people 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
- 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 \ 120 bpm, AV block [second or greater degree], bundle branch block) or vital sign abnormalities...
- 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...
- 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...
- 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 how well it works
- 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...
- 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)
The study team makes the final eligibility decision.
Where it's taking place
- Fountain Valley, California, United States
- Gainesville, Florida, United States
- Boston, Massachusetts, United States
- Ann Arbor, Michigan, United States
- East Lansing, Michigan, United States
- Farmington Hills, Michigan, United States
- New York, New York, United States
- Spokane, Washington, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 40 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Fountain Valley, California, United States; Gainesville, Florida, United States; Boston, Massachusetts, United States; Ann Arbor, Michigan, United States; East Lansing, Michigan, United States; Farmington Hills, Michigan, United States and 2 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.