Healthy Volunteers (HV)Phase 1NCT07310264
Research Into the Safety of a New Agent (VT-5006) in People With and Without Parkinson's Disease
A Phase 1 study testing VT-5006 in people with Healthy Volunteers (HV) and Parkinson's Disease (PD), run by Vertero Therapeutics at 1 site in Netherlands.
Trial summary
This is a first-in-human (FIH) study of orally administered VT-5006 (also known as AX-5006) in healthy adult volunteers (HVs) and adult participants with Parkinson's disease (PD). The goal of this clinical trial is to learn if VT-5006 is safe and tolerable in healthy volunteers and in participants with PD. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers (HV), Parkinson's Disease (PD)
- What is being tested?
- VT-5006
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 84 participants
- Where
- 1 siteNetherlands
- Study dates
- 30 Oct 2025to 28 Sep 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Diagnosed with PD confirmed by a neurologist within a maximum of 10 years (based of year of diagnosis) prior to screening
- Has current or history of GI motility dysfunction or persistent constipation
- Score of < 3 on the Modified Hoehn and Yahr Scale
- Is able to swallow multiple and large capsules without assistance or difficulty, in the opinion of the investigator
- Participants should be on a stable regimen of any prescribed (except levodopa/carbidopa, levodopa/benserazide or anticholinergic agents) or over-the-counter medications or supplements for at least 60 days prior to enrolment in the study. Participants should not change the dosage or frequency of these medications or supplements while in the study. If changes to medications or supplements are contemplated during the study, the Investigator should be contacted prior to any change.
- Has suitable venous access for blood sampling
Who cannot join
- Has a known allergy or hypersensitivity to any component of the formulation of VT-5006 or matching placebo, or history of severe allergy or anaphylaxis to a drug, food, or other exposure
- Participants taking levodopa/carbidopa or levodopa/benserazide must remain on a stable dose and regimen from at least 21 days prior to Day 1 visit to end of study (EOS) visit. Other treatments for PD symptoms may be allowed at the discretion of the medical monitor
- Has any clinically significant arrhythmia(s) on ECG; specifically, the participant's corrected QT interval (QTcf) (Fridericia's correction) is >450 ms for males or >470 ms for females
- Has clinically significant abnormalities, as judged by the investigator, in laboratory test results (including hepatic and renal panels, complete blood count, chemistry panel and urinalysis). In the case of uncertain or questionable results, tests performed during screening may be repeated before randomization to confirm eligibility or judged to be clinically irrelevant for healthy participants
- Has any of the following test results: a serum total bilirubin value >1.5 x upper limit of normal (ULN); a serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) value 2x ULN. As an exception, participants that present with elevated bilirubin in the absence of elevations in ALT or AST that fits the pattern of Gilbert's syndrome may be enrolled after discussion with the medical monitor if their conjugated bilirubin is not or slightly elevated and the level is considered to be not clinically significant.
- Any history of lumbar surgery for any reason (e.g. herniated disc) that in the opinion of the Investigator would interfere with or pose risks to a lumbar puncture procedure
- Other contraindications to having a lumbar puncture
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site, 1 recruiting
- Recruiting
Center for Human Drug Research
Leiden
P.H.C. Kremer, +31 0715246400, clintrials@chdr.nl
About this study
Official title: A Phase I, Randomized, Single Ascending Dose, Multiple Ascending Dose, Double-Blind Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AX-5006 (Aka VT-5006) in Healthy Participants and Participants With Parkinson's Disease.
This is a first-in-human (FIH) study of orally administered VT-5006 (also known as AX-5006) in healthy adult volunteers (HVs) and adult participants with Parkinson's disease (PD). The goal of this clinical trial is to learn if VT-5006 is safe and tolerable in healthy volunteers and in participants with PD. It has three Parts (A, B, and C).
Part A: Healthy volunteers aged 18-54 will attend a screening visit, take a single dose of VT-5006 or matching placebo after an overnight fast, stay in the clinic for three nights, and complete a follow-up visit. One group of participants in Part A will be asked to return to the clinic after approximately two weeks, take a single dose of VT-5006 or matching placebo after consuming a high-fat meal and stay in the clinic for another three nights.
Read more
Part B: Healthy volunteers aged 18-54 will attend a screening visit, take one dose of VT-5006 or matching placebo each day for seven days after fasting overnight, stay in the clinic for 10 nights, and complete a follow up visit.
Part C: Participants with PD aged 40-80 will attend a screening visit, take one dose of VT-5006 (high dose), VT-5006 (low dose), or matching placebo each day for 28 days, complete two overnight stays in the clinic, attend three clinic visits, one phone call and a follow up visit.
Read the detailed description
Part A will consist of five single ascending dose (SAD) cohorts, with 8 participants in each cohort. Participants will be randomized to receive either VT-5006 or placebo in a 6:2 ratio. One cohort of 8 participants will complete an additional clinic stay for the purpose of evaluating food effect (FE).
Part B will consist of two multiple ascending dose (MAD) cohorts, with 10 participants in each cohort. Participants will be randomized to receive either VT-5006 or placebo in an 8:2 ratio.
Part C will consist of a single cohort of approximately 24 (or up to 32) participants with PD, randomized to receive either VT-5006 (high dose), VT-5006 (low dose) or placebo over 28 days in a 9:9:6 ratio.
- Conditions
- Healthy Volunteers (HV), Parkinson's Disease (PD)
- Being tested
- VT-5006, Placebo
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VT-5006Drug
Also called AX-5006
Oral Capsules, Active
PlaceboDrug
Oral Capsules, Matched Placebo
| Study group | Role | What they receive |
|---|---|---|
| Part A SAD Active | Experimental | Single Ascending Doses of VT-5006 Receives: Drug: VT-5006 |
| Part A SAD Placebo | Placebo comparator | Matched Placebo Receives: Drug: Placebo |
| Part B MAD Active | Experimental | Multiple ascending doses of VT-5006 Receives: Drug: VT-5006 |
| Part B MAD Placebo | Placebo comparator | Matched Placebo Receives: Drug: Placebo |
| Part C Active Low Dose | Experimental | Low dose VT-5006 Receives: Drug: VT-5006 |
| Part C Active High Dose | Experimental | High dose VT-5006 Receives: Drug: VT-5006 |
| Part C Placebo | Placebo comparator | Matched placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with treatment-related adverse events (AEs)
Incidence of treatment-emergent AEs (e.g. clinically significant electrocardiogram, vital signs and physical examination abnormalities; clinically significant changes on the Columbia-Suicide Severity Rating Scale [C-SSRS]).
Measured: Part A: Up to 8 days; Part B: Up to 15 days; Part C: Up to 35 days;
Secondary outcomes (14)
Plasma pharmacokinetic (PK) parameter: Cmax
Maximum peak plasma concentration (Cmax)
Measured: Part A: predose, and up to 72 hours postdose; Part B: predose, and up to 37 hours postdose on Days 1 and 7; Part C: predose, and up to 10 hours postdose on Days 1 and 28
Plasma PK parameter: Tmax
Time to Maximum Observed Concentration (Tmax)
Measured: Part A: predose, and up to 72 hours postdose; Part B: predose, and up to 37 hours postdose on Days 1 and 7; Part C: predose, and up to 10 hours postdose on Days 1 and 28
Plasma PK parameter: AUClast
Area under the plasma concentration-time curve from time zero to the time of last quantifiable concentration (AUClast)
Measured: Part A: predose, and up to 72 hours postdose; Part B: predose, and up to 37 hours postdose on Days 1 and 7; Part C: predose, and up to 10 hours postdose on Days 1 and 28
Plasma PK parameters: AUCinf
Area under the concentration-time curve extrapolated to infinity (AUCinf)
Measured: Part A: predose, and up to 72 hours postdose; Part B: predose, and up to 37 hours postdose on Days 1 and 7; Part C: predose, and up to 10 hours postdose on Days 1 and 28
Plasma PK parameter: t1/2
Terminal-phase elimination half-life (t1/2)
Measured: Part A: predose, and up to 72 hours postdose; Part B: predose, and up to 37 hours postdose on Days 1 and 7; Part C: predose, and up to 10 hours postdose on Days 1 and 28
Plasma PK parameter: Apparent CL/F
Apparent clearance (CL/F)
Measured: Part A: predose, and up to 72 hours postdose; Part B: predose, and up to 37 hours postdose on Days 1 and 7; Part C: predose, and up to 10 hours postdose on Days 1 and 28
Plasma PK parameter: Apparent Vd/F
Apparent volume of distribution (Vd/F)
Measured: Part A: predose, and up to 72 hours postdose; Part B: predose, and up to 37 hours postdose on Days 1 and 7; Part C: predose, and up to 10 hours postdose on Days 1 and 28
Food effect on plasma PK: Cmax
Cmax following a high fat meal
Measured: Part A: predose and up to 72 hours postdose
Food effect on plasma PK: Tmax
Tmax following a high fat meal
Measured: Part A: predose and up to 72 hours postdose
Food effect on plasma PK: AUC
AUC following a high fat meal
Measured: Part A: predose and up to 72 hours postdose
Urine PK parameter: CLr
Renal clearance rate (CLr)
Measured: Part A: Up to 72 hours postdose; Part B: Up to 24 hours postdose on Days 1 and 7; Part C: Up to 8 hours postdose on Days 1 and 28
Urine PK parameter: Cumulative amount excreted (urine)
Cumulative amount excreted in urine
Measured: Part A: Up to 72 hours postdose; Part B: Up to 24 hours postdose on Days 1 and 7; Part C: Up to 8 hours postdose on Days 1 and 28
Urine PK parameter: %Cumulative amount excreted
Percent cumulative amount excreted in urine
Measured: Part A: Up to 72 hours postdose; Part B: Up to 24 hours postdose on Days 1 and 7; Part C: Up to 8 hours postdose on Days 1 and 28
Feces PK parameter: Observed concentration
Observed concentration in fecal samples (ng/mL)
Measured: Part A: 0-72 hours postdose; Part B: 0-12 hours and 12-24 hours postdose on Days 1 and 7, and anytime postdose on Day 4; Part C: Anytime postdose on Days 8, 15, 22 and 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2025
- Study start30 Oct 2025
- Primary completion28 Sep 2026 (estimated)
- Study completion28 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Volunteers (HV)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vertero Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07310264
- Sponsor's protocol ID
- VT-5006-101
- Other IDs
- 2025-523254-14-00, AXL-5006-101, 2025
- Status last verified
- Mar 2026
- First submitted
- 17 Nov 2025
- Last updated
- 20 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Randomized, Single Ascending Dose, Multiple Ascending Dose, Double-Blind Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AX-5006 (Aka VT-5006) in Healthy Participants and Participants With Parkinson's Disease.
- ClinicalTrials.gov ID
- NCT07310264
- Acronym / sponsor ID
- VT-5006-101
- Conditions
- Healthy Volunteers (HV), Parkinson's Disease (PD)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Vertero TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 30 Oct 2025 (actual)
- Primary completion
- 28 Sep 2026 (estimated)
- Study completion
- 28 Sep 2026 (estimated)
- First posted
- 30 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a first-in-human (FIH) study of orally administered VT-5006 (also known as AX-5006) in healthy adult volunteers (HVs) and adult participants with Parkinson's disease (PD). The goal of this clinical trial is to learn if VT-5006 is safe and tolerable in healthy volunteers and in participants with PD. It has three Parts (A, B, and C).
Part A: Healthy volunteers aged 18-54 will attend a screening visit, take a single dose of VT-5006 or matching placebo after an overnight fast, stay in the clinic for three nights, and complete a follow-up visit. One group of participants in Part A will be asked to return to the clinic after approximately two weeks, take a single dose of VT-5006 or matching placebo after consuming a high-fat meal and stay in the clinic for another three nights.
Part B: Healthy volunteers aged 18-54 will attend a screening visit, take one dose of VT-5006 or matching placebo each day for seven days after fasting overnight, stay in the clinic for 10 nights, and complete a follow up visit.
Part C: Participants with PD aged 40-80 will attend a screening visit, take one dose of VT-5006 (high dose), VT-5006 (low dose), or matching placebo each day for 28 days, complete two overnight stays in the clinic, attend three clinic visits, one phone call and a follow up visit.
Detailed description
Part A will consist of five single ascending dose (SAD) cohorts, with 8 participants in each cohort. Participants will be randomized to receive either VT-5006 or placebo in a 6:2 ratio. One cohort of 8 participants will complete an additional clinic stay for the purpose of evaluating food effect (FE).
Part B will consist of two multiple ascending dose (MAD) cohorts, with 10 participants in each cohort. Participants will be randomized to receive either VT-5006 or placebo in an 8:2 ratio.
Part C will consist of a single cohort of approximately 24 (or up to 32) participants with PD, randomized to receive either VT-5006 (high dose), VT-5006 (low dose) or placebo over 28 days in a 9:9:6 ratio.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Part A SAD Active | Experimental | Drug: VT-5006Single Ascending Doses of VT-5006 |
| Part A SAD Placebo | Placebo comparator | Drug: PlaceboMatched Placebo |
| Part B MAD Active | Experimental | Drug: VT-5006Multiple ascending doses of VT-5006 |
| Part B MAD Placebo | Placebo comparator | Drug: PlaceboMatched Placebo |
| Part C Active Low Dose | Experimental | Drug: VT-5006Low dose VT-5006 |
| Part C Active High Dose | Experimental | Drug: VT-5006High dose VT-5006 |
| Part C Placebo | Placebo comparator | Drug: PlaceboMatched placebo |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Diagnosed with PD confirmed by a neurologist within a maximum of 10 years (based of year of diagnosis) prior to screening
- Has current or history of GI motility dysfunction or persistent constipation
- Score of < 3 on the Modified Hoehn and Yahr Scale
- Is able to swallow multiple and large capsules without assistance or difficulty, in the opinion of the investigator
- Participants should be on a stable regimen of any prescribed (except levodopa/carbidopa, levodopa/benserazide or anticholinergic agents) or over-the-counter medications or supplements for at least 60 days prior to enrolment in the study. Participants should not change the dosage or frequency of these medications or supplements while in the study. If changes to medications or supplements are contemplated during the study, the Investigator should be contacted prior to any change.
Key exclusion criteria (7 listed)
- Has a known allergy or hypersensitivity to any component of the formulation of VT-5006 or matching placebo, or history of severe allergy or anaphylaxis to a drug, food, or other exposure
- Participants taking levodopa/carbidopa or levodopa/benserazide must remain on a stable dose and regimen from at least 21 days prior to Day 1 visit to end of study (EOS) visit. Other treatments for PD symptoms may be allowed at the discretion of the medical monitor
- Has any clinically significant arrhythmia(s) on ECG; specifically, the participant's corrected QT interval (QTcf) (Fridericia's correction) is >450 ms for males or >470 ms for females
- Has clinically significant abnormalities, as judged by the investigator, in laboratory test results (including hepatic and renal panels, complete blood count, chemistry panel and urinalysis). In the case of uncertain or questionable results, tests performed during screening may be repeated before randomization to confirm eligibility or judged to be clinically irrelevant for healthy participants
- Has any of the following test results: a serum total bilirubin value >1.5 x upper limit of normal (ULN); a serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) value 2x ULN. As an exception, participants that present with elevated bilirubin in the absence of elevations in ALT or AST that fits the pattern of Gilbert's syndrome may be enrolled after discussion with the medical monitor if their conjugated bilirubin is not or slightly elevated and the level is considered to be not clinically significant.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VT-5006Also: AX-5006Oral Capsules, Active | Drug | Part A SAD Active, Part B MAD Active, Part C Active High Dose, Part C Active Low Dose |
| PlaceboOral Capsules, Matched Placebo | Drug | Part A SAD Placebo, Part B MAD Placebo, Part C Placebo |
Primary outcome
Number of participants with treatment-related adverse events (AEs)
Time frame: Part A: Up to 8 days; Part B: Up to 15 days; Part C: Up to 35 days;
Incidence of treatment-emergent AEs (e.g. clinically significant electrocardiogram, vital signs and physical examination abnormalities; clinically significant changes on the Columbia-Suicide Severity Rating Scale [C-SSRS]).
14 secondary outcomes
Plasma pharmacokinetic (PK) parameter: Cmax
Time frame: Part A: predose, and up to 72 hours postdose; Part B: predose, and up to 37 hours postdose on Days 1 and 7; Part C: predose, and up to 10 hours postdose on Days 1 and 28
Plasma PK parameter: Tmax
Time frame: Part A: predose, and up to 72 hours postdose; Part B: predose, and up to 37 hours postdose on Days 1 and 7; Part C: predose, and up to 10 hours postdose on Days 1 and 28
Plasma PK parameter: AUClast
Time frame: Part A: predose, and up to 72 hours postdose; Part B: predose, and up to 37 hours postdose on Days 1 and 7; Part C: predose, and up to 10 hours postdose on Days 1 and 28
Plasma PK parameters: AUCinf
Time frame: Part A: predose, and up to 72 hours postdose; Part B: predose, and up to 37 hours postdose on Days 1 and 7; Part C: predose, and up to 10 hours postdose on Days 1 and 28
Plasma PK parameter: t1/2
Time frame: Part A: predose, and up to 72 hours postdose; Part B: predose, and up to 37 hours postdose on Days 1 and 7; Part C: predose, and up to 10 hours postdose on Days 1 and 28
Plasma PK parameter: Apparent CL/F
Time frame: Part A: predose, and up to 72 hours postdose; Part B: predose, and up to 37 hours postdose on Days 1 and 7; Part C: predose, and up to 10 hours postdose on Days 1 and 28
Plasma PK parameter: Apparent Vd/F
Time frame: Part A: predose, and up to 72 hours postdose; Part B: predose, and up to 37 hours postdose on Days 1 and 7; Part C: predose, and up to 10 hours postdose on Days 1 and 28
Food effect on plasma PK: Cmax
Time frame: Part A: predose and up to 72 hours postdose
Food effect on plasma PK: Tmax
Time frame: Part A: predose and up to 72 hours postdose
Food effect on plasma PK: AUC
Time frame: Part A: predose and up to 72 hours postdose
Urine PK parameter: CLr
Time frame: Part A: Up to 72 hours postdose; Part B: Up to 24 hours postdose on Days 1 and 7; Part C: Up to 8 hours postdose on Days 1 and 28
Urine PK parameter: Cumulative amount excreted (urine)
Time frame: Part A: Up to 72 hours postdose; Part B: Up to 24 hours postdose on Days 1 and 7; Part C: Up to 8 hours postdose on Days 1 and 28
Urine PK parameter: %Cumulative amount excreted
Time frame: Part A: Up to 72 hours postdose; Part B: Up to 24 hours postdose on Days 1 and 7; Part C: Up to 8 hours postdose on Days 1 and 28
Feces PK parameter: Observed concentration
Time frame: Part A: 0-72 hours postdose; Part B: 0-12 hours and 12-24 hours postdose on Days 1 and 7, and anytime postdose on Day 4; Part C: Anytime postdose on Days 8, 15, 22 and 28
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing VT-5006 in people with Healthy Volunteers (HV) and Parkinson's Disease (PD), run by Vertero Therapeutics at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact P.H.C. Kremer (+31 0715246400, clintrials@chdr.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with treatment-related adverse events (AEs) (time frame: Part A: Up to 8 days; Part B: Up to 15 days; Part C: Up to 35 days;). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2026.