Trial Review

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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12626001022358
Ethics application status
Help: Ethics application status
Approved
Date submitted
Help: Date submitted
26/06/2026
Date registered
Help: Date registered
19/08/2026
Date last updated
Help: Date last updated
4/09/2026
Date data sharing statement initially provided
Help: Data sharing statement date
19/08/2026
Type of registration
Help: Type of registration
Prospectively registered

Titles & IDs
Public title
A Phase 1, First-in-Human, Double-Blind, Placebo-Controlled Single Ascending Dose Study of MT-001 in Adult Participants
Scientific title
Evaluate the Safety and Tolerability of A Phase 1, First-in-Human, Double-Blind, Placebo-Controlled Single Ascending Dose Study of MT-001 in Adult Participants.
Additional trial identifiers [1] 317576 0
MT-001-101
Universal Trial Number (UTN)
Trial acronym
Related trial records

Health condition
Health condition(s) studied:
Migraines 342326 0
Condition category
Condition code
Neurological 338457 338457 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
This is a phase 1, first-in-human (FIH), double-blind, placebo-controlled single ascending dose study. Approximately 40 adult participants will be randomized 6:2 (MT-001:placebo) in up to 5 planned dosing cohorts of 8 participants each. MT-001 will be administered as single ascending SC or IV doses, with escalation based on emerging safety, tolerability, and PK data following Safety Review Committee review. Participants will be dosed at the study site by qualified site staff, with administration documented to confirm adherence. Each participant will be randomized to only 1 cohort and receive only 1 dose of MT-001 or placebo by SC injection or IV infusion on Day 1. Planned cohorts are as follows:
• Dose Group 1 (SC)
• Dose Group 2 (SC)
• Dose Group 3 (SC)
• Dose Group 4 (IV)
• Dose Group 5 (IV)
Each dosing cohort will commence with a sentinel group of 2 participants, randomized 1:1 to receive MT-001 or placebo.
Intervention code [1] 334377 0
Treatment: Drugs
Description of the comparator or control
Each participant will be randomised to receive with MT-001 or placebo on Day 1 by SC injection or IV depending on the cohort.
Placebo is supplied as a sterile solution in 20 mM histidine/histidine hydrochloride, 70 mM arginine hydrochloride, 135 mM sorbitol, 0.1% (w/v) poloxamer 188, with a pH of 5.8.
Control group
Placebo

Outcomes
Primary outcome [1] 345753 0
To evaluate the safety and tolerability of a single MT-001 injection (either subcutaneous or intravenous. This will be assessed as a composite outcome.
Timepoint [1] 345753 0
TEARs, Physical exam, Vital signs will be assessed at each scheduled visit post dose. Day 1 post dose, Day 2, Day 3, Day 4, Day 7, Day 15, Day 28, Day 56, Day 84, Day 168, Day 252 and Day 335.
Secondary outcome [1] 464805 0
To characterize the PK profile of MT-001 after single SC or IV doses in adult participants
Timepoint [1] 464805 0
PK testing will take place at the following timepoints: Day 1, Day 2, Day 3, Day 4, Day 7, Day 15, Day 28, Day 56, Day 84, Day 168, Day 252 and Day 335.

Eligibility
Key inclusion criteria
1. Sign the informed consent form (ICF)
2. Healthy adult males and females, 18 to 55 years old (inclusive) at screening.
3. Body mass index (BMI) 18 to 35 kg/m² (inclusive) a body weight < 120 kg at screening
4. Agree to use adequate contraception from screening through end of the study.
5. Willing and able to remain at the study site unit for the duration of the confinement period and return for the outpatient visits defined in the protocol
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Healthy volunteers
Yes
Key exclusion criteria
1. Any clinically significant medical condition or finding that, in the Investigator's opinion, is likely to unfavorably alter the risk of study participation, confound study results, or interfere with the study conduct or compliance.
2. History of illicit drug use or drug abuse or harmful alcohol use
3. Unwilling to abstain from regular, continuous alcohol use (defined as an average of more than 10 standard drinks per week)
4. Volunteer must be a non-smoker (inclusive of nicotine containing products such a vapes or e-cigarettes).
5. History of severe allergic reactions or hypersensitivity
6. Females who are pregnant or breastfeeding, or are planning to become pregnant or breastfeed.
7. Use of investigational drug therapy within 30 days prior to enrollment
8. Unable to comply with study requirements or in the opinion of the Investigator should not participate in this study.

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)
Mentari will be providing MT-001 and placebo in vials for SC administration or IV preparation. The statistician will provide the randomization schedule which the unblinded pharmacist at the site will use to assign the treatment (MT-001 or placebo).
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be randomly assigned in a 6:2 ratio to receive MT-001 or placebo using a block randomisation algorithm and will be documented in the study randomisation schedule.
Masking / blinding
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
31/08/2026
Actual
Date of last participant enrolment
Anticipated
14/12/2026
Actual
Date of last data collection
Anticipated
15/11/2027
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment outside Australia
Country [1] 28206 0
New Zealand
State/province [1] 28206 0

Funding & Sponsors
Funding source category [1] 322134 0
Commercial sector/Industry
Name [1] 322134 0
Mentari Therapeutics, Inc.
Country [1] 322134 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Mentari Therapeutics, Inc.
Address
Country
United States of America
Secondary sponsor category [1] 325025 0
Commercial sector/Industry
Name [1] 325025 0
Avance Clinical Pty Ltd
Address [1] 325025 0
Country [1] 325025 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 320663 0
Central Health and Disability Ethics Committee
Ethics committee address [1] 320663 0
Ethics committee country [1] 320663 0
New Zealand
Date submitted for ethics approval [1] 320663 0
24/06/2026
Approval date [1] 320663 0
23/07/2026
Ethics approval number [1] 320663 0

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

Contacts
Principal investigator
Name 151214 0
Dr Rohit Katial
Address 151214 0
New Zealand Clinical Research, 3 Ferncroft Street, Grafton, Auckland 1010
Country 151214 0
New Zealand
Phone 151214 0
+64 9 373 3474
Fax 151214 0
Email 151214 0
[email protected]
Contact person for public queries
Name 151215 0
Dr Rohit Katial
Address 151215 0
New Zealand Clinical Research, 3 Ferncroft Street, Grafton, Auckland 1010
Country 151215 0
New Zealand
Phone 151215 0
+64 9 373 3474
Fax 151215 0
Email 151215 0
[email protected]
Contact person for scientific queries
Name 151216 0
Dr Rohit Katial
Address 151216 0
New Zealand Clinical Research, 3 Ferncroft Street, Grafton, Auckland 1010
Country 151216 0
New Zealand
Phone 151216 0
+64 9 373 3474
Fax 151216 0
Email 151216 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.