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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05633745




Registration number
NCT05633745
Ethics application status
Date submitted
21/11/2022
Date registered
1/12/2022
Date last updated
26/10/2023

Titles & IDs
Public title
A Study to Assess NEU-723 in Healthy Participants
Scientific title
A Phase 1, Single and Multiple Ascending Dose Study of NEU-723 Administered Orally to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics in Healthy Subjects
Secondary ID [1] 0 0
NEU-723-PD101
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-723
Treatment: Drugs - Placebo

Experimental: NEU-723 - Part A: Single-ascending dose cohorts; Part B: Multiple-ascending dose cohorts (7 days)

Placebo comparator: Placebo - Part A: Single-ascending dose cohorts; Part B: Multiple-ascending dose cohorts (7 days)


Treatment: Drugs: NEU-723
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-723 in healthy subjects
Assessment method [1] 0 0
Incidence of Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Timepoint [1] 0 0
Up to 7 days of dosing
Secondary outcome [1] 0 0
PK Parameter
Assessment method [1] 0 0
The maximum concentration (Cmax) at steady state in plasma
Timepoint [1] 0 0
Up to 7 days of dosing
Secondary outcome [2] 0 0
PK Parameter
Assessment method [2] 0 0
The area under the concentration-time curve from zero to infinity (AUC0-inf) in plasma
Timepoint [2] 0 0
Up to 7 days of dosing
Secondary outcome [3] 0 0
PK Parameter
Assessment method [3] 0 0
The time to reach maximum concentration (tmax) in plasma
Timepoint [3] 0 0
Up to 7 days of dosing
Secondary outcome [4] 0 0
PK Parameter
Assessment method [4] 0 0
Area under the concentration-time curve from time zero to the time of last quantifiable concentration (AUC\[0-last\]) in plasma
Timepoint [4] 0 0
Up to 7 days of dosing
Secondary outcome [5] 0 0
PK Parameter
Assessment method [5] 0 0
Apparent terminal elimination half-life (t1/2) in plasma
Timepoint [5] 0 0
Up to 7 days of dosing
Secondary outcome [6] 0 0
PK Parameter
Assessment method [6] 0 0
The terminal elimination rate constant (?Z) with the respective half-life (t½) in plasma
Timepoint [6] 0 0
Up to 7 days of dosing
Secondary outcome [7] 0 0
PK Parameter
Assessment method [7] 0 0
The oral clearance (CL/F)
Timepoint [7] 0 0
Up to 7 days of dosing
Secondary outcome [8] 0 0
PK Parameter
Assessment method [8] 0 0
The volume of distribution (Vd/F)
Timepoint [8] 0 0
Up to 7 days of dosing
Secondary outcome [9] 0 0
PK Parameter
Assessment method [9] 0 0
The area under the concentration-time curve over a dosing interval (AUC0-t) in plasma (multiple dosing only)
Timepoint [9] 0 0
Up to 7 days of dosing

Eligibility
Key inclusion criteria
1. Subjects for standard cohorts must be 18-80 years, inclusive, at the time of signing the informed consent;
2. 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)
3. Subjects who have a body mass index (BMI) of 18-32 kg/m2(inclusive);
4. 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;
5. 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
80 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. History of clinically significant hematological, renal, pancreatic, gastrointestinal, hepatic, cardiovascular, metabolic, endocrine, immunological, allergic disease, or other major disorders
2. History of clinically significant abnormal chest x-ray
3. Clinically significant neurologic disorder
4. Contraindications to undergo a lumbar puncture (only for subjects participating in the MAD)

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
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
30/01/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
30/06/2023
Sample size
Target
Accrual to date
Final
40
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Christchurch

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


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/NCT05633745