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

Part of paid clinical trials in Farmington Hills, Michigan.

Sponsor
Hillhurst Biopharmaceuticals, Inc.
Study ID
NCT07005180
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
40 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • HBI-002 — DRUG
    Oral liquid containing carbon monoxide
  • Vehicle (placebo) — DRUG
    Vehicle control (placebo)

Study Details

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).

Key Dates

Start date
May 15, 2026
Status verified
May 2026
Primary completion
Dec 31, 2026
Completion
Mar 31, 2027

Study Design

Enrollment
36 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: High Dose
  • Experimental: Low Dose
  • Placebo Comparator: Placebo

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 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Quest Research InstituteFarmington HillsMichigan48334
Tamsin Andres
[email protected]

Find similar trials in Farmington Hills, MI

By condition
Parkinson's disease
By specialty
NeurologyBrain disorders
By research site
Quest Research Institute· Farmington Hills, MI

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