HealthyPhase 1NCT06900751
A Study to Assess NEU-627 in Healthy Participants
A Phase 1 study testing NEU-627 in people with Healthy, run by Neuron23 Inc. at 1 site in New Zealand.
Trial summary
Phase 1, randomized, double-blind, placebo-controlled study of NEU-627 designed to evaluate safety, tolerability, pharmacokinetics, pharmacodynamics, and food effect. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- NEU-627
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 74 participants
- Where
- 1 siteNew Zealand
- Study dates
- 2 Jun 2025to 28 Oct 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participants are eligible to be included in the study only if all of the following criteria apply.
- Male and female participants must be 18-60 years, inclusive, at the time of signing the informed consent;
- Participants must be in good general health according to the judgment of the Investigator per local guidance;
- Participants who have a body mass index (BMI) of 18-32 kg/m2 (inclusive);
- When engaging in sex with a woman of child-bearing potential, both the male participant and his female partner must use highly effective contraception;
- Legally and ethically capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
Who cannot join
- Participants are excluded from the study if any of the following criteria apply.
- Clinically significant infection and/or dermatological, cardiovascular, hematological, renal, hepatic, pulmonary, endocrine, gastrointestinal, immunological, neurological, or psychiatric disease which could interfere with, or the treatment for which might interfere with, the conduct of the study or which would, in the opinion of the Investigator, unacceptably increase the participant's risk if he/she were to participate in the study;
- Any history of malignant disease in the last 5 years;
- Presence of clinically relevant immunosuppression from, but not limited to, immunodeficiency conditions;
- Use of or plans to use systemic immunosuppressive or immunomodulating medications during the study or within 3 months prior to the first study drug administration;
- Current infection that requires systemically absorbed antibiotic, antifungal, antiparasitic or antiviral medications;
Show all 9Show fewer
- Positive screen for hepatitis B surface antigen, hepatitis C antibody, or human immunodeficiency virus antibody/antigen;
- History of active, latent, or inadequately treated tuberculosis infection.
- Additional details and criteria are outlined in the full study protocol.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1 Study of NEU-627 to Evaluate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Food Effect in Healthy Volunteers
Phase 1, randomized, double-blind, placebo-controlled study of NEU-627 designed to evaluate safety, tolerability, pharmacokinetics, pharmacodynamics, and food effect.
Read the detailed description
This is a Phase 1 study that will utilize a randomized, double-blind placebo controlled single ascending dose schema, a 10-day multiple ascending dose schema, and open-label schemas to study food effect and to determine cerebrospinal fluid concentration of NEU-627. The study will evaluate safety, tolerability, pharmacokinetics, pharmacodynamics, and food effect of NEU-627 in male and female healthy volunteers between 18 to 60 years old, inclusive.
- Conditions
- Healthy
- Being tested
- NEU-627, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NEU-627Drug
Investigational medicinal product
PlaceboOther
Placebo
| Study group | Role | What they receive |
|---|---|---|
| NEU-627 | Experimental | Part A: Single-ascending dose cohorts; Part B: Multiple-ascending dose cohort; Part C: Open-label, food effect evaluation; and Part D: Open-label, determination of cerebrospinal concentration Receives: Drug: NEU-627 |
| Placebo | Experimental | Part A: Single-ascending dose cohorts; Part B: Multiple-ascending dose cohort Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the safety and tolerability of single and multiple doses of NEU-627 in healthy participants
Incidence of Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Measured: Up to 10 days of dosing
Secondary outcomes (3)
Evaluation of maximum concentration (Cmax) after single and multiple doses of NEU-627
Measured: Up to 10 days of dosing
NEU-627 concentrations
Measured: Up to 10 days of dosing
Change from baseline of the corrected QT interval
Measured: Up to 10 days of dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2025
- Study start2 Jun 2025
- Primary completion28 Oct 2025
- Study completion28 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Neuron23 Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06900751
- Sponsor's protocol ID
- NEU-627-MS101
- Status last verified
- Jan 2026
- First submitted
- 17 Mar 2025
- Last updated
- 15 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study of NEU-627 to Evaluate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Food Effect in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT06900751
- Acronym / sponsor ID
- NEU-627-MS101
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Neuron23 Inc.Industry (pharma, biotech, devices)
- Study start
- 2 Jun 2025 (actual)
- Primary completion
- 28 Oct 2025 (actual)
- Study completion
- 28 Oct 2025 (actual)
- First posted
- 28 Mar 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.
Phase 1, randomized, double-blind, placebo-controlled study of NEU-627 designed to evaluate safety, tolerability, pharmacokinetics, pharmacodynamics, and food effect.
Detailed description
This is a Phase 1 study that will utilize a randomized, double-blind placebo controlled single ascending dose schema, a 10-day multiple ascending dose schema, and open-label schemas to study food effect and to determine cerebrospinal fluid concentration of NEU-627. The study will evaluate safety, tolerability, pharmacokinetics, pharmacodynamics, and food effect of NEU-627 in male and female healthy volunteers between 18 to 60 years old, inclusive.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NEU-627 | Experimental | Drug: NEU-627Part A: Single-ascending dose cohorts; Part B: Multiple-ascending dose cohort; Part C: Open-label, food effect evaluation; and Part D: Open-label, determination of cerebrospinal concentration |
| Placebo | Experimental | Other: PlaceboPart A: Single-ascending dose cohorts; Part B: Multiple-ascending dose cohort |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Participants are eligible to be included in the study only if all of the following criteria apply.
- Male and female participants must be 18-60 years, inclusive, at the time of signing the informed consent;
- Participants must be in good general health according to the judgment of the Investigator per local guidance;
- Participants who have a body mass index (BMI) of 18-32 kg/m2 (inclusive);
- When engaging in sex with a woman of child-bearing potential, both the male participant and his female partner must use highly effective contraception;
Key exclusion criteria (9 listed)
- Participants are excluded from the study if any of the following criteria apply.
- Clinically significant infection and/or dermatological, cardiovascular, hematological, renal, hepatic, pulmonary, endocrine, gastrointestinal, immunological, neurological, or psychiatric disease which could interfere with, or the treatment for which might interfere with, the conduct of the study or which would, in the opinion of the Investigator, unacceptably increase the participant's risk if he/she were to participate in the study;
- Any history of malignant disease in the last 5 years;
- Presence of clinically relevant immunosuppression from, but not limited to, immunodeficiency conditions;
- Use of or plans to use systemic immunosuppressive or immunomodulating medications during the study or within 3 months prior to the first study drug administration;
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 |
|---|---|---|
| NEU-627Investigational medicinal product | Drug | NEU-627 |
| PlaceboPlacebo | Other | Placebo |
Primary outcome
Evaluate the safety and tolerability of single and multiple doses of NEU-627 in healthy participants
Time frame: Up to 10 days of dosing
Incidence of Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
3 secondary outcomes
Evaluation of maximum concentration (Cmax) after single and multiple doses of NEU-627
Time frame: Up to 10 days of dosing
NEU-627 concentrations
Time frame: Up to 10 days of dosing
Change from baseline of the corrected QT interval
Time frame: Up to 10 days of dosing
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2026.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 NEU-627 in people with Healthy, run by Neuron23 Inc. at 1 site in New Zealand.
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 9 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: finished, as of the sponsor's last update on 15 Jan 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 New Zealand. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the safety and tolerability of single and multiple doses of NEU-627 in healthy participants (time frame: Up to 10 days of dosing). 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 15 Jan 2026.