Phase 1 study for people with Parkinson's Disease
Recruiting Phase 1
This trial at a glance
Where this trial is running
| Site | City | State or country | Status at this site |
|---|---|---|---|
| Alfred Hospital | Melbourne | VIC | Recruiting |
| Monash Medical Center | Melbourne | VIC | Recruiting |
| Nucleus Networks | Melbourne | VIC | Active not recruiting |
voxsanity.com.au · trial sites from public registries · registry record synced 11 October 2026 · not medical advice
Who can join
The official eligibility criteria
Registry text, reproduced exactly. These are the words the trial's sponsor published on ClinicalTrials.gov. They have not been edited, shortened or rewritten, and they are written for researchers rather than for patients.
Both cohorts (Healthy Volunteers and Parkinson's Disease)
Key inclusion criteria
* Male or female, 30-89 years inclusive at screening
* BMI 18-32 kg/m²
* Vital signs, ECG (QTcF \<450 ms male / \<470 ms female), and safety labs without clinically significant abnormality; no orthostatic hypotension
* Women of non-childbearing potential, or using highly effective contraception per protocol
Key exclusion criteria
* Immunomodulators / steroids - HV: any (incl. OTC) within 90 days; PD: systemic within 60 days and topical/nasal-inhaled OTC within 7 days (both waivable only with Sponsor approval)
* Vaccine within 60 days (HV) / 45 days (PD) of first dose
* CoQ10 within 5 days
* Inadequate renal function (CrCl ≤ 60 mL/min; ≤ 79 if HV under 40), or LFTs / bilirubin \> 1.5× ULN
* Clinically significant cardiovascular, hepatic, renal, neurological, or psychiatric disease
* Active infection requiring systemic anti-infectives within 14 days; positive HBV/HCV/HIV serology
Parkinson's Disease participants - additional key inclusion criteria
* PD diagnosis by a neurologist/geriatrician, 6 months to \< 11 years before first dose, per MDS clinical diagnostic criteria
* Hoehn \& Yahr stage 1-3
* If on levodopa: stable ≥ 2 months and able to withhold ≥ 12 hours (overnight) around dosing/assessments; if not, remain treatment-naïve through end of study
Parkinson's Disease participants - additional key exclusion criteria
* Prior PD brain surgery, focused ultrasound, or neuromodulation; no anti-amyloid/anti-tau biologics
* Antibiotics within 30 days; OTC pre/probiotics; ≥ 3 unexplained falls in 12 months
Note: Additional protocol-defined criteria apply.
Dates on the record
Results, publications and the official record
- No results are posted on the official record yet.
- No publications are listed on the official record yet.
- Official record and contacts on ClinicalTrials.gov – contact details for each site are kept there, and are not copied onto this page.
Sources and dates
- ClinicalTrials.gov – the record this page reformats
- ClinicalTrials.gov processing date: 25 September 2026.
- This page last checked by Voxsanity: 11 October 2026.
Voxsanity reformats data from public registries into this layout. It does not edit, interpret or add to what the registry published.
Not medical advice.
Individual trial records are refreshed on a rolling basis rather than all at once, so a record may be up to several weeks old. Each trial page and trial card shows the date its own record was last synced. Where a record has lagged, its status, sites and enrolment can differ from the current registry state in either direction, so check the registry link on the trial page before acting on them.
Letter for your doctor
A one-page summary of this trial to print or email to your GP. It carries the registry's own record of the trial and its eligibility criteria, and nothing Voxsanity has written about whether it suits you.