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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12626000899347
Ethics application status
Help: Ethics application status
Approved
Date submitted
Help: Date submitted
11/07/2026
Date registered
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21/07/2026
Date last updated
Help: Date last updated
22/09/2026
Date data sharing statement initially provided
Help: Data sharing statement date
21/07/2026
Type of registration
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Prospectively registered

Titles & IDs
Public title
Study to Evaluate Safety, Tolerability and PK of study drug SLTE-1009 in Healthy Adult Patients
Scientific title
A Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of SLTE-1009 Administered by Intravenous or Subcutaneous Injection in Healthy Adult Participants
Additional trial identifiers [1] 317660 0
SLTE-1009-101 Version 1.0
Universal Trial Number (UTN)
Trial acronym
Related trial records

Health condition
Health condition(s) studied:
Migraine 342459 0
Condition category
Condition code
Neurological 338584 338584 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
Part 1: Single Ascending Dose (SAD) part will be conducted as a placebo-controlled single dose study to assess the safety, tolerability, and PK of a single dose of SLTE-1009 administered in healthy adult participants. Participants will be randomized in a 3:1 ratio per cohort (n=8) to receive SLTE-1009 or placebo.
Each participant in SAD will receive SLTE-1009 or placebo as an IV infusion (100mL/hr infusion rate) on Day 1.
Five (5) cohorts are planned, evaluating doses of 50, 150, 300, 600, and 1000 mg. Participants will be admitted to the Clinical Research Unit on Day -1 and will be discharged on Day 2. Two sentinel participants will be deployed in each cohort in the SAD. In the absence of any safety concerns, at the discretion of the Principal Investigator (PI) or designee, the remainder of the cohort will be administered study drug.

Part 2: Multiple Ascending Dose (MAD) part will be conducted as a placebo-controlled MAD study to assess the safety, tolerability, and PK of multiple doses of SLTE-1009 administered as a subcutaneous injection in healthy adult participants. Participants will be randomized in a 3:1 ratio per cohort (n=8) to receive SLTE-1009 or placebo. Each participant in MAD will receive a subcutaneous (SC) dose of SLTE-1009 or placebo on Day 1, followed by additional doses at the same dose level on Days 15 and 29. Three (3) cohorts are planned, evaluating doses of 150, 300, and 600 mg but final dose determination will be based on the SAD part of the protocol.

Depending on available safety data, the Sponsor along with the SRC may decide to eliminate doses or expand dosing cohorts.
Adherence to the intervention will be monitored through direct administration of all doses by qualified study personnel at the Clinical Research Unit. Dosing will be documented in source records and drug accountability records, and participants will be monitored according to the protocol-defined schedule.
Intervention code [1] 334489 0
Treatment: Drugs
Description of the comparator or control
The placebo used in both Part 1 and Part 2 studies is a sterile saline solution commercially available.
Control group
Placebo

Outcomes
Primary outcome [1] 345887 0
SAD: Composite assessment of safety and tolerability following single intravenous dose administration of SLTE-1009, evaluated by the incidence of adverse events (AEs), changes in vital signs, electrocardiograms (ECGs), clinical laboratory parameters and physical examination
Timepoint [1] 345887 0
AEs: From Day 1 (Screening) up to Day 169 (End of study) Vital Signs: From Day 1 (Screening) up to Day 169 (End of study). Electrocardiograms (ECGs): Days 1,4 and 29. Laboratory parameters: Days 1,4,29,85 and 169. Physical Examination: Day 1.
Primary outcome [2] 345888 0
MAD: Composite assessment of safety and tolerability following Multiple Subcutaneous dose administration of SLTE-1009, evaluated by the incidence of adverse events (AEs), changes in vital signs, electrocardiograms (ECGs), clinical laboratory parameters and physical examination
Timepoint [2] 345888 0
AEs: From Day 1 (Screening) up to Day 197 (End of study) Vital Signs: From Day 1 (Screening) up to Day 197 (End of study). Electrocardiograms (ECGs): Days 1,15,16,29,30,42,85 and 197. Laboratory parameters: Days 1,15,16,29,30,42,85 and 197. Physical Examination: Days 1,15 and 29.
Secondary outcome [1] 463672 0
SAD: Pharmacokinetics (PK) of SLTE-1009 following single Intravenous ascending doses.
Timepoint [1] 463672 0
Days 1 (Predose),2,3,4,8,15,29,57,85,113,141 and 169 post-dose
Secondary outcome [2] 463675 0
MAD: Pharmacokinetics (PK) of SLTE-1009 following Multiple Subcutaneous ascending doses.
Timepoint [2] 463675 0
Days 1 (Predose),2,3,4,6,8,15 (Predose),29 (Predose),30,31,32,34,36,42,57,85,113,141,169 and 197 post-dose
Secondary outcome [3] 463679 0
SAD: Incidence of Anti-Drug Antibodies (ADAs) following a single intravenous dose of SLTE-1009 administered to healthy adult participants
Timepoint [3] 463679 0
Days 1,8,15,29,57 and 169
Secondary outcome [4] 463681 0
MAD: Incidence of Anti-Drug Antibodies (ADAs) following multiple doses of SLTE-1009 administered as a subcutaneous injection to healthy adult participants
Timepoint [4] 463681 0
Days 1,15,29,57,85,169 and 197

Eligibility
Key inclusion criteria
- At the discretion of the PI or designee, in good general health, with no significant medical history, and have no clinically significant abnormalities on physical examination at Screening and/or before the first administration of SLTE-1009.
- Body mass index (BMI) between 18.0 and 32.0 kg/m2 and weight more than or equal to 50 and less than or equal to 100 kg
- Nonsmoker or smokes less than or equal to 5 cigarettes or equivalent (eg, cigars, vaping, nicotine patches) per week.
- Vital signs result within the following normal ranges respiration rate (RR) 10-22, heart rate 40-100, blood pressure (after participant is lying supine for approximately 5 minutes) 90-140, Temp 35.5-37.5-degree Celsius, blood oxygen SpO2 >95%
- A woman of childbearing potential (WOCBP) or fertile man must have been using an acceptable method of contraception more than 30 days prior to Screening and agrees to continue using the acceptable method of contraception until 6 months after the last dose of SLTE-1009.
- Male participants must agree to not donate sperm for 6 months after last dose of SLTE-1009
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Healthy volunteers
Yes
Key exclusion criteria
- Pregnant, planning to become pregnant, or currently breastfeeding.
- Positive serum pregnancy test at Screening or a positive urine pregnancy test on Day -1.
- Current or recent systemic infection within 2 weeks prior to Screening or infection requiring IV antibiotics within 4 weeks prior to Screening.
- Recent surgery requiring general anesthesia within 12 weeks prior to Screening or is expected to have surgery requiring general anesthesia during the course of the study.
- Estimated glomerular filtration rate (eGFR) < 60 mL/min/1.73 m 2 (using the CKD-EPI 2021 formula)
- Elevated liver function tests defined as total bilirubin or alkaline phosphatase (ALP), aspartate aminotransferase (AST), or alanine aminotransferase (ALT) =>1.5 × upper limit of normal (ULN) at Screening.
- Any of the following:
a. Known congenital long QT syndrome.
b. Fridericia-corrected QT interval (QTcF) at Screening greater than or equal to 450 ms for a male or greater than or equal to 470 ms for a female.
c. Abnormal ECG findings at Screening that are considered by the PI or designee to be clinically significant.
- History of malignancy, except for non-melanoma skin cancer, excised more than 1 year prior to Screening and cervical intraepithelial neoplasia that has been successfully cured more than 5 years prior to Screening.
- History of severe allergic or anaphylactic reactions, or known sensitivity to SLTE-1009 constituents.
- History of stroke or history of stroke before age 50 in first degree relatives
- Positive drugs and/or alcohol screen.

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)
Allocation is concealed through a paper-based randomization system, where the randomization list is generated by an unblinded statistician and provided only to the unblinded pharmacist. Site investigators and study staff do not have access to the randomization schedule.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomization sequence is generated by an unblinded statistician using a predefined randomization schedule, with implementation through a paper-based system.
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
Recruiting
Date of first participant enrolment
Anticipated
28/08/2026
Actual
25/08/2026
Date of last participant enrolment
Anticipated
30/04/2027
Actual
Date of last data collection
Anticipated
12/11/2027
Actual
Sample size
Target
72
Accrual to date
8
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 322200 0
Commercial sector/Industry
Name [1] 322200 0
Slate Medicines
Country [1] 322200 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Slate Medicines
Address
Country
United States of America
Secondary sponsor category [1] 325109 0
None
Name [1] 325109 0
Address [1] 325109 0
Country [1] 325109 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 320724 0
Alfred Hospital Ethics Committee
Ethics committee address [1] 320724 0
Ethics committee country [1] 320724 0
Australia
Date submitted for ethics approval [1] 320724 0
24/06/2026
Approval date [1] 320724 0
27/07/2026
Ethics approval number [1] 320724 0

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

Contacts
Principal investigator
Name 151422 0
Dr Ofer Gonen
Address 151422 0
Nucleus Network, Level 3, 549 St Kilda Road, Melbourne VIC 3004
Country 151422 0
Australia
Phone 151422 0
+61 1800 243 733
Fax 151422 0
Email 151422 0
[email protected]
Contact person for public queries
Name 151423 0
Roger Cady
Address 151423 0
Slate Medicines, 4114 Center at North Hills, Suite 250, Raleigh, NC 27609
Country 151423 0
United States of America
Phone 151423 0
+1 980 788 2456
Fax 151423 0
Email 151423 0
[email protected]
Contact person for scientific queries
Name 151424 0
Roger Cady
Address 151424 0
Slate Medicines, 4114 Center at North Hills, Suite 250, Raleigh, NC 27609
Country 151424 0
United States of America
Phone 151424 0
+1 980 788 2456
Fax 151424 0
Email 151424 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.