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

NCT07005180 | Not Yet Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: HBI-002-221
• Study Type: interventional
• Target: 36
• Locations: 0 countries
• Sites: N/A

Brief 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).

Conditions

Parkinson Disease

Keywords

Parkinson Disease; HBI-002; low dose carbon monoxide

Outcome Measures

Primary Outcomes (1)

• Frequency and severity of treatment-emergent AEs related to HBI-002 compared to placebo.

  From treatment to 30 days after the end of treatment

Secondary Outcomes (1)

• Pharmacokinetics as measured by carboxyhemoglobin (COHb) levels

  Days 1 and 14

Study Arms (3)

High Dose

EXPERIMENTAL

Drug: HBI-002

Low Dose

EXPERIMENTAL

Drug: HBI-002

Placebo

PLACEBO COMPARATOR

Drug: Vehicle (placebo)

Interventions

HBI-002 DRUG

Oral liquid containing carbon monoxide

High Dose; Low Dose

Vehicle (placebo) DRUG

Vehicle control (placebo)

Placebo

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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.

You may not qualify if:

• 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
• 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)

Sponsors & Collaborators

• Hillhurst Biopharmaceuticals, Inc.: lead
• The Parkinson Study Group: collaborator

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Central Study Contacts

President and CEO

CONTACT

858-232-9495; hillhurstinfo@hillhurstbio.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 28, 2025
• First Posted: June 5, 2025
• Study Start: February 28, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): March 31, 2027
• Last Updated: January 8, 2026

Record last verified: 2026-01