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

Part of paid clinical trials in Fountain Valley, California.

Sponsor
Hillhurst Biopharmaceuticals, Inc.
Study ID
NCT07005180
Phase
PHASE2
Status
Recruiting
Apply to this trial

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

First listed
Jun 5, 2025
Start date
Jun 30, 2026
Status verified
Aug 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 (5)

FacilityCityStateZIPSite coordinators
The Parkinson's & Movement Disorder InstituteFountain ValleyCalifornia92708
Emily Nguyen
[email protected]
University of FloridaGainesvilleFlorida32608
Camille Swartz
[email protected]
Quest Research InstituteFarmington HillsMichigan48334
Tamsin Andres
[email protected]
Weill Cornell Medical CollegeNew YorkNew York10021
Charles Snajdr-Trinch
[email protected]
Inland Northwest ResearchSpokaneWashington99202
Lindsey Strom
[email protected]

Find similar trials in Fountain Valley, CA

Nationwide
Parkinson's disease trialsNeurology trialsBrain disorders trials
By condition
Parkinson's disease
By specialty
NeurologyBrain disorders
By research site
The Parkinson's & Movement Disorder Institute· Fountain Valley, CAUniversity of Florida· Gainesville, FLQuest Research Institute· Farmington Hills, MIWeill Cornell Medical College· New York, NYInland Northwest Research· Spokane, WA

Related Studies