Trial Review

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 registered on ANZCTR


Registration number
Help: Registration number
ACTRN12626000651381
Ethics application status
Help: Ethics application status
Approved
Date submitted
Help: Date submitted
13/05/2026
Date registered
Help: Date registered
1/06/2026
Date last updated
Help: Date last updated
1/06/2026
Date data sharing statement initially provided
Help: Data sharing statement date
1/06/2026
Type of registration
Help: Type of registration
Prospectively registered

Titles & IDs
Public title
A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Drug-Drug Interactions of NB-9402 in Healthy Adult Volunteers - Part C Drug-Drug Interactions
Scientific title
A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Drug-Drug Interactions of NB-9402 in Healthy Adult Volunteers
Additional trial identifiers [1] 317272 0
NB-9402-101
Universal Trial Number (UTN)
Trial acronym
Related trial records

Health condition
Health condition(s) studied:
Diseases of the nervous system 341899 0
Condition category
Condition code
Neurological 337958 337958 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
This study involves 1 single cohort of 8 participants. Each participant will receive a single dose of a two-probe oral cocktail containing 0.5 mg of repaglinide and 1 mg midazolam on Day 1, Day 11 and Day 16, and once-daily doses of NB-9402 administered as an oral liquid (via oral syringe), followed by a water rinse and swallow for 14 days, commencing on Day 2.
Intervention code [1] 334046 0
Treatment: Drugs
Description of the comparator or control
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 345394 0
Evaluate potential drug-drug interactions between NB-9402 and CYP2C8 (repaglinide) as well as CYP3A4 (midazolam) substrates in healthy volunteers.
Timepoint [1] 345394 0
Blood samples will be collected for pharmacokinetic (PK) analysis for Repaglinide and Midazolam a the following timepoints on days 1, 11 and 16: Predose (within 5 minutes of dose), 15 minutes, 30 minutes, 45 minutes, 1 hour, 1.5 hours, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours and 24 hours post-dose.
Primary outcome [2] 345488 0
To evaluate the safety of NB-9402 dosing once daily for 14 days in healthy volunteers.
Timepoint [2] 345488 0
All AEs will be recorded from the time of signing consent through the end-of-study (EOS) visit. Changes from baseline assessments will be measured at the following timepoints: Clinical lab safety tests Day 1, 3, 7, 11, 15 and 22/EOS. ECGs - Daily days 1-18 and day 22/EOS. Vital signs - Daily days 1-18 and day 22/EOS. Physical Examinations - Day 1, 3, 5, 7, 11, 15, 18 and 22/EOS.
Secondary outcome [1] 461518 0
To evaluate the PK of NB-9402 upon dosing once daily for 14 days in healthy volunteers.
Timepoint [1] 461518 0
Blood samples will be collected for PK analysis at the following timepoints: - Day 2 and 11: Predose (within 5 minutes of dose), 30 minutes, 1 hour, 2 hours, 4 hours, 6 hours, 8 hours, 12 hours and 24 hours post-dose. - Day 15: Predose (within 5 minutes of dose), 1 hour, 2 hours, 4 hours, 8 hours and 24 hours post-dose. - Day 16: 1 hour and 24 hours post dose.

Eligibility
Key inclusion criteria
1. Participant must be >/= 18 years and < /= 65 years old at the time of signing informed consent.
2. Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring (ECG) obtained within 28 days before study drug administration.
3. Baseline laboratory test values within reference ranges based on the blood and urine samples taken at screening and on Day-1.
4. Nonsmoker and/or ex-smoker who has discontinued smoking and/or use of nicotine-containing products for at least 3 months prior to the first dose of study drug.
5. Ability to communicate well with the Investigator, in the local language, and to understand and comply with the requirements of the study.
6. Body mass index (BMI) within the range 18 to 32 kg/m2 (inclusive).
7. Females must be either postmenopausal for >/=1 year (or with FSH >/= 40 mlU/mL at screening if postmenopausal for< 1 year) or surgically sterile (having undergone bilateral tubal ligation, hysterectomy, or bilateral oophorectomy) for at least 6 months. However, to protect against the transfer of the study drug in any bodily fluids, male partners of female participants (whether postmenopausal or surgically sterile) must use a barrier form (e.g., condom) of contraception until the EOS visit or 7 days after the last dose of study drug in case of early termination.
8. Males with female partners of childbearing potential will agree to use barrier contraceptive (i.e., condom) and their female partners must use a highly effective method of contraception from screening to go days after the last dose of study drug. Males must also refrain from sperm donations during this time period. Males who are abstinent will not be required to use a contraceptive method unless they become sexually active. Males in a same sex relationship must also use a barrier form of contraception against the transfer of the study drug in any bodily fluids until the EOS visit or 7 days after the last dose of study drug in case of early termination.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Healthy volunteers
Yes
Key exclusion criteria
1. History or presence of significant cardiovascular, respiratory. hepatic. renal, gastrointestinal, endocrinological. hematological, or neurological disorders capable of significantly altering the absorption. metabolism, or elimination of drugs: constituting a risk when taking the study intervention: or interfering with the interpretation of data.
2. Any significant chronic medical illness, as determined by the Investigator.
3. Mentally or legally incapacitated. has significant emotional problems at screening or expected during the conduct of the study, or has a history of a clinically significant psychiatric disorder within the last 5 years. Note: normal healthy volunteers who have had situational depression without suicidal ideation or behavior may be enrolled in the study at the discretion of the Investigator.
4. The participant has a history of severe drug allergy or hypersensitivity or food allergy, including anaphylaxis.
5. The participant has had surgery or trauma with significant blood loss within the last 3 months prior to the first dose of study drug.
6. The participant has donated more than 1 unit (500 ml) of blood within 4 weeks prior to the first dose of study drug.
7, Fever (body temperature >38'C) or symptomatic viral or bacterial infection within 2 weeks prior to screening.
8. Any abnormal vital signs -at screening or before the first administration of study drug- considered to be clinically significant by the Investigator.
9. Lymphoma, leukemia, or any malignancy within the past 5 years except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years. Fully resected basal cell carcinoma (BCCl and squamous cell carcinoma (SCC) with no evidence of recurrence for 1 year are permitted.
10. Breast cancer within the past 10 years.
11. Any clinically significant laboratory abnormality at the screening visit or before the administration of the first dose of study drug.
12. Current or chronic history of liver disease or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
13. QTcF interval (QT with Fridericia's correction)> 450 msec in males and> 470 msec in females (based on the mean of triplicate measurements taken at screening).
14. Females of childbearing potential, irrespective of contraceptive measures taken.
15. Inability to tolerate oral medications.
16. Past or intended use of over-the-counter or prescription medication (including herbal medications) within 14 days before dosing.
17. Live vaccine(s) within 1 month before screening or plans to receive such vaccines during the study.
18. Treatment with biologic agents (such as monoclonal antibodies, including marketed drugs) within 3 months or 5 half-lives (whichever is longer) before dosing.
19. Current participation in any other investigational drug study or receipt of an investigational drug within 30 days or 5 half-lives (whichever is longer) before Day -1 for all Parts.
20. Positive prestudy drug or alcohol screen.
21. Positive human immunodeficiency virus (HIV) or hepatitis C antibody test (HCV), or hepatitis B surface antigen (HBsAgl at screening or 3 months before enrollment.
22. Regular alcohol consumption within 6 months before the study defined, current evidence of substance dependence or self-reported alcoholic intake> 2 drinks/day for female participants and > 3 drinks/day for male participants.
23. Use of tobacco products (e.g., cigarettes, e-cigarettes, cigars, smokeless tobacco) confirmed by a positive cotinine test.
24. Regular use of known drugs of abuse or a history of drug abuse within 12 months prior to screening.
25. Sensitivity to any of the study drug, or components thereof, or drug or other allergy that. in the opinion of the Investigator or Medical Monitor, contraindicates participation in the study.
26. Known hypersensitivity to midazolam or any of the formulation components, or history of acute narrow angle glaucoma. Participants with open-angle glaucoma must have well-controlled disease.
27. Known hypersensitivity to repaglinide or any of the formulation components or history of ketoacidosis.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint/s
Safety
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
17/06/2026
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
8
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 29521 0
Scientia Clinical Research - Randwick
Recruitment postcode(s) [1] 45838 0
2031 - Randwick

Funding & Sponsors
Funding source category [1] 321848 0
Commercial sector/Industry
Name [1] 321848 0
Nura Bio Inc
Country [1] 321848 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Nura Bio Inc
Address
Country
United States of America
Secondary sponsor category [1] 324702 0
Commercial sector/Industry
Name [1] 324702 0
InClin Pty Ltd
Address [1] 324702 0
Country [1] 324702 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 320387 0
Bellberry Human Research Ethics Committee K
Ethics committee address [1] 320387 0
Ethics committee country [1] 320387 0
Australia
Date submitted for ethics approval [1] 320387 0
01/04/2026
Approval date [1] 320387 0
07/05/2026
Ethics approval number [1] 320387 0

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

Contacts
Principal investigator
Name 150314 0
Dr Christopher Argent
Address 150314 0
Scientia Clinical Research, The Bright Building, Level 5, Corner High & Avoca Streets, Randwick NSW 2031
Country 150314 0
Australia
Phone 150314 0
+61 2 9382 5800
Fax 150314 0
Email 150314 0
[email protected]
Contact person for public queries
Name 150315 0
Mr Taylor Kilfoil
Address 150315 0
InClin Inc, Suite 210, 25/29 Berry Street, North Sydney, NSW, Australia, 2060.
Country 150315 0
Australia
Phone 150315 0
+61 408 880 403
Fax 150315 0
Email 150315 0
[email protected]
Contact person for scientific queries
Name 150316 0
Mr Taylor Kilfoil
Address 150316 0
InClin Inc, Suite 210, 25/29 Berry Street, North Sydney, NSW, Australia, 2060.
Country 150316 0
Australia
Phone 150316 0
+61 408 880 403
Fax 150316 0
Email 150316 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.