Register a trial

Reset your password and enable multi-factor authentication (MFA)


For ANZCTR account holders: to help ensure the cyber safety of your account, you’ll need to reset your password and set-up multi-factor authentication (MFA) as per the instructions below.


  1. Go to the Login page, click ‘reset password’ and follow the instructions.
  2. Check your email for the link to set a new password.
  3. Create a new password that meets requirements. New passwords must include at least one lowercase letter, one uppercase letter, one number and one special character (e.g. !#$%&@).
  4. Return to the Login page and enter your new password. A verification code will be sent to your email.
  5. Check your email for the code and enter it on the Login page. If the code is entered incorrectly, you can re-enter the correct one or request a new one.

Learn more about MFA and its importance on the Australian Signals Directorate website.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06900751




Registration number
NCT06900751
Ethics application status
Date submitted
17/03/2025
Date registered
28/03/2025

Titles & IDs
Public title
A Study to Assess NEU-627 in Healthy Participants
Scientific title
A Phase 1 Study of NEU-627 to Evaluate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Food Effect in Healthy Volunteers
Secondary ID [1] 0 0
NEU-627-MS101
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Healthy 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - NEU-627
Other interventions - Placebo

Experimental: NEU-627 - 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

Experimental: Placebo - Part A: Single-ascending dose cohorts; Part B: Multiple-ascending dose cohort


Treatment: Drugs: NEU-627
Investigational medicinal product

Other interventions: Placebo
Placebo
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Evaluate the safety and tolerability of single and multiple doses of NEU-627 in healthy participants
Timepoint [1] 0 0
Up to 10 days of dosing
Secondary outcome [1] 0 0
Evaluation of maximum concentration (Cmax) after single and multiple doses of NEU-627
Timepoint [1] 0 0
Up to 10 days of dosing
Secondary outcome [2] 0 0
NEU-627 concentrations
Timepoint [2] 0 0
Up to 10 days of dosing
Secondary outcome [3] 0 0
Change from baseline of the corrected QT interval
Timepoint [3] 0 0
Up to 10 days of dosing

Eligibility
Key inclusion criteria
Inclusion criteria:

Participants are eligible to be included in the study only if all of the following criteria apply.

1. Male and female participants must be 18-60 years, inclusive, at the time of signing the informed consent;
2. Participants must be in good general health according to the judgment of the Investigator per local guidance;
3. Participants who have a body mass index (BMI) of 18-32 kg/m2 (inclusive);
4. When engaging in sex with a woman of child-bearing potential, both the male participant and his female partner must use highly effective contraception;
5. 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.
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Participants are excluded from the study if any of the following criteria apply.

1. 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;
2. Any history of malignant disease in the last 5 years;
3. Presence of clinically relevant immunosuppression from, but not limited to, immunodeficiency conditions;
4. 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;
5. Current infection that requires systemically absorbed antibiotic, antifungal, antiparasitic or antiviral medications;
6. Positive screen for hepatitis B surface antigen, hepatitis C antibody, or human immunodeficiency virus antibody/antigen;
7. History of active, latent, or inadequately treated tuberculosis infection.

Additional details and criteria are outlined in the full study protocol.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
1/05/2025
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/11/2025
Actual
Sample size
Target
96
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Aukland

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Neuron23 Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Anna Bakardjiev, MD
Address 0 0
Country 0 0
Phone 0 0
415-632-8942
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06900751