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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05755191




Registration number
NCT05755191
Ethics application status
Date submitted
22/02/2023
Date registered
6/03/2023
Date last updated
18/11/2024

Titles & IDs
Public title
A Study to Assess NEU-411 in Healthy Participants
Scientific title
A Phase 1, Single and Multiple Ascending Dose and Food Effect Study of NEU-411 Administered Orally to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics in Healthy Subjects
Secondary ID [1] 0 0
NEU-411-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-411
Treatment: Drugs - Placebo

Experimental: NEU-411 - Part A: Single-ascending dose cohorts; food effect; Part B: Multiple-ascending dose cohorts (7 days)

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


Treatment: Drugs: NEU-411
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 dosing, food effect and multiple oral doses of NEU-411 in healthy subjects
Timepoint [1] 0 0
Up to 7 days of dosing
Secondary outcome [1] 0 0
PK parameter
Timepoint [1] 0 0
Up to 7 days of dosing
Secondary outcome [2] 0 0
PK parameter
Timepoint [2] 0 0
Up to 7 days of dosing
Secondary outcome [3] 0 0
PK parameter
Timepoint [3] 0 0
Up to 7 days of dosing
Secondary outcome [4] 0 0
PK parameter
Timepoint [4] 0 0
Up to 7 days of dosing
Secondary outcome [5] 0 0
PK parameter
Timepoint [5] 0 0
Up to 7 days of dosing
Secondary outcome [6] 0 0
PK parameter
Timepoint [6] 0 0
Up to 7 days of dosing
Secondary outcome [7] 0 0
PK parameter
Timepoint [7] 0 0
Up to 7 days of dosing
Secondary outcome [8] 0 0
PK parameter
Timepoint [8] 0 0
Up to 7 days of dosing
Secondary outcome [9] 0 0
PK parameter
Timepoint [9] 0 0
Up to 7 days of dosing

Eligibility
Key inclusion criteria
* Subjects for standard cohorts must be 18-80 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
80 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
* History of clinically significant abnormal chest x-ray
* Clinically significant neurologic disorder
* 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
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
22/05/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
3/06/2024
Sample size
Target
Accrual to date
Final
147
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.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This is a Phase 1, randomized, double-blind, placebo-controlled, single ascending dose (SAD), food effect (FE),multiple ascending dose (MAD), drug-drug interaction study, and bioavailability - bio-equivalence study of orally administered NEU-411 in healthy subjects
Trial website
https://clinicaltrials.gov/study/NCT05755191
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
Sam Jackson, MD
Address 0 0
Country 0 0
Phone 0 0
510-998-4122
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT05755191