Register a trial

Did you know?

The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.

These enhancements will offer a more comprehensive view of trials, regardless of whether their results are positive, negative, or inconclusive.

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/NCT06500442




Registration number
NCT06500442
Ethics application status
Date submitted
8/07/2024
Date registered
15/07/2024

Titles & IDs
Public title
A Study to Assess NEU-111 in Healthy Participants
Scientific title
A Phase 1 Study of NEU-111 Administered Orally to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics in Healthy Volunteers
Secondary ID [1] 0 0
NEU-111-UC101
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-111
Treatment: Drugs - Placebo

Experimental: NEU-111 - Part A: Single-ascending dose cohorts; Part B: Multiple-ascending dose cohort (10 days)

Placebo comparator: Placebo - Part A: Single-ascending dose cohorts; Part B: Multiple-ascending dose cohorts (10 days)


Treatment: Drugs: NEU-111
Oral Doses

Treatment: Drugs: Placebo
Oral Doses
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Evaluate the safety and tolerability of single and multiple oral doses of NEU-111 in healthy subjects
Timepoint [1] 0 0
Up to 10 days of dosing
Secondary outcome [1] 0 0
PK Parameter
Timepoint [1] 0 0
Up to 10 days of dosing
Secondary outcome [2] 0 0
PK Parameter
Timepoint [2] 0 0
Up to 10 days of dosing
Secondary outcome [3] 0 0
PK Parameter
Timepoint [3] 0 0
Up to 10 days of dosing
Secondary outcome [4] 0 0
PK Parameter
Timepoint [4] 0 0
Up to 10 days of dosing
Secondary outcome [5] 0 0
PK Parameter
Timepoint [5] 0 0
Up to 10 days of dosing
Secondary outcome [6] 0 0
PK Parameter
Timepoint [6] 0 0
Up to 10 days of dosing
Secondary outcome [7] 0 0
PK Parameter
Timepoint [7] 0 0
Up to 10 days of dosing
Secondary outcome [8] 0 0
PK Parameter
Timepoint [8] 0 0
Up to 10 days of dosing
Secondary outcome [9] 0 0
PK Parameter
Timepoint [9] 0 0
Up to 10 days of dosing

Eligibility
Key inclusion criteria
Subjects for standard cohorts must be 18-64 years, inclusive, at the time of signing the informed consent; Subjects who are in good general health with no clinically relevant abnormalities based on the medical history, physical examinations, neurological examinations, clinical laboratory evaluations (hematology and clinical chemistry) Subjects who have a body mass index (BMI) of 18-32 kg/m2(inclusive);

Male subjects are eligible to participate if they are rendered surgically sterile (at least 6 months), or agree to the following during the study and for at least 30 days after the last dose of study drug:

• Refrain from donating sperm;

AND, either:

Be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent; OR Agree to use a male condom (contraception/barrier) and should also be advised of the benefit for a female partner to use an acceptable, highly effective method of contraception as a condom may break or leak when having sexual intercourse;

Female subjects are eligible to participate if they are not pregnant or breastfeeding, subject to one of the following:

Women of childbearing potential (WOCBP), defined as women physiologically capable of becoming pregnant, must have a negative serum pregnancy test at the Screening visit and a negative urine pregnancy test on Day -1; WOCBP must agree to use an acceptable, highly effective contraceptive method from Screening until 30 days after the last dose of study treatment (see Section 11.3); OR Menopausal women must have an elevated serum follicle-stimulating hormone level (FSH) level at Screening; if the FSH is not elevated, they are considered to be of childbearing potential (unless permanently sterile) and must have a negative serum pregnancy test at Screening and a negative urine pregnancy test on Day -1;
Minimum age
18 Years
Maximum age
64 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
History of clinically significant hematological, renal, pancreatic, gastrointestinal, hepatic, cardiovascular, metabolic, endocrine, immunological, allergic disease, or other major disorders Presence of clinically relevant immunosuppression from, but not limited to, immunodeficiency conditions such as common variable hypogammaglobulinemia; Use of or plans to use systemic immunosuppressive (e.g., corticosteroids, methotrexate, azathioprine, cyclosporine) or immunomodulating medications (e.g., interferon) during the study or within 3 months prior to the first study drug administration;

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
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
17/09/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/02/2025
Actual
Sample size
Target
64
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Auckland

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
anna.bakardjiev@neuron23.com
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
No/undecided IPD sharing reason/comment


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/NCT06500442