NCT07005180

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

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)

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 36 (estimated)
• Sponsor: Hillhurst Biopharmaceuticals, Inc. · Industry
• Sex: All
• Age: 40 Years – 80 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
DRUG	HBI-002	Oral liquid containing carbon monoxide
DRUG	Vehicle (placebo)	Vehicle control (placebo)

Timeline

• Start date: 2026-02-28
• Primary completion: 2026-12-31
• Completion: 2027-03-31
• First posted: 2025-06-05
• Last updated: 2026-01-08

Regulatory

• FDA-regulated drug study