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

Study acronym: LoCaMoTE-PD
StatusRecruiting
PhasePhase 2
Started

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Record History

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  1. Trial sites expanded: 5 → 8 locations
    • Eligibility criteria expanded, about 73 words
    • Collaborators: details revised at 1 of 3 entries
  2. Trial sites expanded: 1 → 5 locations
    • Collaborators: 1 to 3
    v5
  3. Study sites: 1 to 5
    • Start date changed from estimate of May 15, 2026 to Jun 30, 2026
    v4
  4. Recruitment opened
    • Start date: Feb 28, 2026 to May 15, 2026
    • Study sites: 0 to 1
    v3
  5. Primary completion date: Dec 31, 2025 to Dec 31, 2026v2 Show 4 more changesShow less
    • Start date: Aug 31, 2025 to Feb 28, 2026
    • Study completion date: Mar 31, 2026 to Mar 31, 2027
    • Eligibility criteria expanded, about 83 words
    • Collaborators expanded, about 4 words
  6. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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).
Trial Details
NCT Number NCT07005180
Lead Sponsor Hillhurst Biopharmaceuticals, Inc.
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
Conditions
(from sponsor)		 Parkinson Disease
Related terms Parkinson Disease
Enrollment 36 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov