Low-dose Carbon Monoxide (HBI-002) Trial to Evaluate Safety, Tolerability, PK, and Biomarkers in Parkinson's Disease
NCT07005180 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 36
Last updated 2026-05-11
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
Interventions
- DRUG
-
HBI-002
Oral liquid containing carbon monoxide
- DRUG
-
Vehicle (placebo)
Vehicle control (placebo)
Sponsors & Collaborators
-
The Parkinson Study Group
collaborator NETWORK -
Hillhurst Biopharmaceuticals, Inc.
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 40 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-05-15
- Primary Completion
- 2026-12-31
- Completion
- 2027-03-31
- FDA Drug
- Yes
Countries
- United States
Study Locations
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