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Trial registered on ANZCTR


Registration number
ACTRN12625000680460p
Ethics application status
Submitted, not yet approved
Date submitted
11/06/2025
Date registered
26/06/2025
Date last updated
26/06/2025
Date data sharing statement initially provided
26/06/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
A Phase 1a/1b trial of a Topical Lysyl Oxidase Inhibitor (SNT-9465) in Healthy Adult Volunteers.
Scientific title
An Integrated Phase 1a/1b, First-in-human, Topical Single and Multiple Dose, Randomized, Double-blinded, Placebo-controlled Study of SNT-9465 in Healthy Adult Volunteers to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics
Secondary ID [1] 314577 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hypertrophic Scars 337682 0
Condition category
Condition code
Injuries and Accidents 334017 334017 0 0
Other injuries and accidents
Skin 334207 334207 0 0
Other skin conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Approximately 32 participants will be enrolled into the study as per below:

Part A (SAD): Approximately 24 participants, enrolled into 1 of 3 SAD cohorts (n=8), randomized 3:1 to SNT-9465 or placebo.

Cohort A1 - 1.0mg (0.5%) Topical Application dosed on Day 1 only, will be applied to 10 cm2 treatment area within the left or right lateral thigh within the clinic under supervision.
Cohort A2 - 4.0mg (2.0%) Topical Application dosed on Day 1 only will be applied to 10 cm2 treatment area within the left or right lateral thigh within the clinic under supervision.
Cohort A3 - 8.0mg (4.0%) Topical Application dosed on Day 1 only will be applied to 10 cm2 treatment area within the left or right lateral thigh within the clinic under supervision.

Part B (multiple dose):
• Cohort B1: Approximately 8 participants, randomised 3:1 to SNT-9465 or placebo;

Cohort B1 dose to be confirmed by Safety Review Committee (SRC) within 3 weeks of the A3 SRC decision. It will be a topical application daily for 28 days and will be applied to 10 cm2 treatment area within the left or right lateral thigh. Days 1,2,15 and 28 will be administered the clinic under supervision. The remaining days the patient will self administer at home with the guidance of stencil and patient diary.
Intervention code [1] 331201 0
Treatment: Drugs
Comparator / control treatment
Placebo for the administration will consist of the same composition as the SNT9465 drug product, minus active ingredient and will consist of a oil based product.
Control group
Placebo

Outcomes
Primary outcome [1] 341675 0
To investigate the safety and tolerability of single ascending doses and multiple doses of SNT-9465 in healthy volunteers.
Timepoint [1] 341675 0
Part A: Adverse events - will be graded using the most current version of the Common Terminology Criteria for Adverse Events (CTCAE) (Version 5) and assessed continuously as they are reported or observed and reviewed through to end of study. Electrocardiogram (ECG) - triplicate 12-lead ECG recordings will be obtained at screening, Single 12-lead ECGs On Day 1 will be performed within 3 hours prior to start of dose application and 4 hours and 12 hours post dose and on Day 2, 24 hours post dose application and End of Treatment (Day 8) Vital signs - Blood pressure and heart rate is measured using sphygmomanometer, respiratory rate by manual breath count and temperature by thermometer. Measured from screening, Day 1 vital signs to be collected within 3 hours prior to start of dose application and 2 hours, 4 hours, 6 hours and 12 hours post and on Day 2, 24 hours post dose application and End of Treatment (Day 8). Full physical examination will be performed at screening. Symptom-directed physical examination will be performed at all subsequent timepoints indicated at Days 2 and 8. Clinical laboratory evaluations (haematology, serum chemistry and urinalysis) - blood and urine samples will be collected from screening, Day -1, Days 1, 2 and 8. Part B1: Adverse events - will be graded using the most current version of the Common Terminology Criteria for Adverse Events (CTCAE) (Version 5) and assessed continuously as they are reported or observed and reviewed through to end of study. Electrocardiogram (ECG) - Triplicate 12-lead ECG will be performed at screening. Single 12-lead ECGs will be performed at all subsequent indicated timepoints. On Day 1, 12-lead ECG will be performed within 3 hours prior to start of dose application and 4 hours and 12 hours post and on Day 2, 24 hours post Day 1 dose application (prior to Day 2 dose application). On Day 28, 12-lead ECG will be performed within 3 hours prior to start of dose application and at 4 hours post-dose and on End Of Treatment Day 35 (35 days post first dose) Vital signs - Blood pressure and heart rate is measured using sphygmomanometer, respiratory rate by manual breath count and temperature by thermometer. Measured from screening, Day 1 vital signs to be collected within 3 hours prior to start of dose application and 2 hours, 4 hours, 6 hours and 12 hours post dose application and on Day 2, 24 hours post Day 1 dose application (prior to Day 2 dose application). On Day 15, visit signs to be collected within 3 hours prior to start of dose application. On Day 28, vital signs to be collected within 3 hours prior to start of dose application and at 2 hours and 4 hours post-dose and End of Treatment day 35 (35 days post first dose). Full physical examination will be performed at screening. Symptom-directed physical examination will be performed at all subsequent timepoints indicated at Days 15, 28 and 35. Clinical laboratory evaluations (haematology, serum chemistry and urinalysis) - blood and urine samples will be collected from screening, Day -1, Days 1, 2, 28 and 35.
Secondary outcome [1] 448847 0
To investigate the pharmacodynamics of SNT 9465 when administered as single ascending doses and multiple doses in healthy volunteers.
Timepoint [1] 448847 0
Part A: Skin biopsies will be obtained for the evaluation of pharmacodynamics (PD) biomarkers within 3 hours prior to start of dose application and 24 hours post-dose (Day 2) Part B: Skin biopsies will be obtained for the evaluation of PD biomarkers within 3 hours prior to start of dose application on Day 1 and Day 28.
Secondary outcome [2] 448308 0
To investigate the pharmacokinetics of SNT 9465 when administered as single ascending doses and multiple doses in healthy volunteers.
Timepoint [2] 448308 0
Part A: On Day 1, blood sample for Pharmacokinetic (PK) analysis will be collected within 3 hours prior to start of dose application and 1 hour, 4 hours, 8 hours, 12 hours and 24 hours post-dose (Day 2). Part B1: On Day 1, blood sample for Pharmacokinetics (PK) analysis will be collected within 3 hours prior to start of dose application and 1 hour, 2 hours, 4 hour, 8 hours, 12 hours and 24 hours post-dose (prior to Day 2 dose application). On Day 28, blood sample for PK analysis will be collected within 1 hour prior to start of dose application and 1 hour, 2 hours and 4 hours post-dose.

Eligibility
Key inclusion criteria
Participants must meet all of the following inclusion criteria to be eligible for this study:

Part A and Cohort B1

1) Male or female aged between 18 and 60 years (inclusive) at the screening visit;
2) Body mass index (BMI) between 18.0 kg/m2 and 32.0 kg/m2 (inclusive) at the screening visit;
3) Adequate venous access in the left or right arm to allow collection of a number of blood samples;
4) Fitzpatrick skin type I, II or III;
5) Male participants must agree to use highly effective methods of contraception from Day -1 through at least 90 days after the last administration of study product;
6) Women of childbearing potential (WOCBP) must be nonpregnant, nonlactating and agree to use highly effective methods of contraception from Day -1 through at least 30 days after the last administration of study product;
7) Male participants must refrain from sperm donation from Day -1 through at least 90 days after the last administration of study product. Female participants must refrain from donation of ova from Day -1 through to at least 30 days after the last administration of study product;
8) Screening and Day -1 laboratory evaluations (e.g., chemistry panel, complete blood count with differential, prothrombin time/activated partial thromboplastin time, urinalysis, C reactive protein, creatinine clearance), vital signs, and electrocardiogram must be within normal limits or judged to be not clinically significant by the Investigator;
9) Able to understand, give consent, and comply with all scheduled study visits, procedures and restrictions.
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Participants meeting any of the following exclusion criteria will not be eligible for this study:

Exclusion Criteria Parts A and B:

1) Clinically significant gastrointestinal, renal, hepatic, neurologic, hematologic, endocrine, oncologic, pulmonary, immunologic, psychiatric, skin, or cardiovascular disease or any other condition, that, in the opinion of the Investigator, would jeopardise the safety of the participant or impact the validity of the study results;
2) Current acute skin condition (e.g. eczema, psoriasis, broken skin, wounds) or large tattoos, scars or excess hair at the study product application site. Normal hair coverage and small blemishes are acceptable at the discretion of the Investigator;
3) History of keloid scarring or hypertrophic scarring
4) History of immediate hypersensitivity to any medication or currently suffers from clinically significant systemic allergic disease;
5) Presence of a currently healing wound, recent musculoskeletal injury, or currently healing fracture;
6) Has received or is anticipated to receive any prescription systemic or topical medication within 14 days or 5 half-lives, whichever is longer, prior to commencement of study product, or use of any over-the-counter, complementary, or alternative medicine within 48 hours prior to commencement of study product. Note: paracetamol up to 2 grams per day, intranasal and inhaled corticosteroids, killed and inactive vaccines, contraceptives, antihistamines, vitamins, and dietary supplements are permitted;
7) Positive screening test for hepatitis panel (HBcAb, HBsAg, anti-HCV) or human immunodeficiency virus (HIV). Positive anti-HCV antibody is allowed if HCV PCR is negative;
8) History of drug abuse in the 2 years prior to screening;
9) Part A and Cohort B1 only: Positive drugs of abuse test at screening or CRU check-in, or positive alcohol breath test at CRU check-in. Participants may undergo 1 repeat urine drug screen or alcohol breath test per time point at the discretion of the Investigator;
10) Receipt of blood donation, or loss or donation of blood equal to or greater than 450 mL, within 30 days prior to commencement of study product, or plasma donation within 14 days before commencement of study product;
11) Has received an experimental therapy within 30 days or 5 half-lives, whichever is longer, prior to commencement of study product;
12) Systemic infection, other than the common cold, in the 7 days prior to commencement of study product.

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)
Participants will be randomized 3:1 to receive SNT9465 or placebo. The unblinded Vendor biostatistician will prepare the study randomization schedule and treatment assignment list and distribute to the site’s unblinded pharmacy team to be kept in an area with restricted access per institutional guidelines. Emergency unblinding codes will be stored securely by the unblinded pharmacy at the research facility.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomization schedule and corresponding treatment assignment will be generated by the Vendor biostatistics department per their standard operating procedures (SOPs).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Safety
Statistical methods / analysis
Participant disposition and demographic characteristics will be summarised using descriptive statistic for the safety Population. All participants administered any amount of study drug will be included in the safety analyses.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
31/07/2025
Actual
Date of last participant enrolment
Anticipated
10/11/2025
Actual
Date of last data collection
Anticipated
27/02/2026
Actual
Sample size
Target
32
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment postcode(s) [1] 44193 0
6027 - Joondalup
Recruitment postcode(s) [2] 44194 0
6009 - Nedlands

Funding & Sponsors
Funding source category [1] 319126 0
Commercial sector/Industry
Name [1] 319126 0
Syntara Limited
Country [1] 319126 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Syntara Limited
Address
Country
Australia
Secondary sponsor category [1] 321590 0
None
Name [1] 321590 0
Address [1] 321590 0
Country [1] 321590 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 317719 0
Bellberry Human Research Ethics Committee A
Ethics committee address [1] 317719 0
Ethics committee country [1] 317719 0
Australia
Date submitted for ethics approval [1] 317719 0
07/05/2025
Approval date [1] 317719 0
Ethics approval number [1] 317719 0

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

Contacts
Principal investigator
Name 141926 0
Mr Sam Salman
Address 141926 0
Linear Clinical Research, B-Block, Hospital Avenue, Nedlands, WA 6009
Country 141926 0
Australia
Phone 141926 0
+61 8 6382 5100
Fax 141926 0
Email 141926 0
[email protected]
Contact person for public queries
Name 141927 0
Sam Salman
Address 141927 0
Linear Clinical Research, B-Block, Hospital Avenue, Nedlands, WA 6009
Country 141927 0
Australia
Phone 141927 0
+61 8 6382 5100
Fax 141927 0
Email 141927 0
[email protected]
Contact person for scientific queries
Name 141928 0
Sam Salman
Address 141928 0
Linear Clinical Research, B-Block, Hospital Avenue, Nedlands, WA 6009
Country 141928 0
Australia
Phone 141928 0
+61 8 6382 5100
Fax 141928 0
Email 141928 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No
No IPD sharing reason/comment: Patient and company confidentiality



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.