Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000685415
Ethics application status
Approved
Date submitted
13/05/2025
Date registered
27/06/2025
Date last updated
27/06/2025
Date data sharing statement initially provided
27/06/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Part B & Part D: Phase I Single and Multiple-Ascending Dose Trial of SPT-320 in Healthy Participants
Scientific title
Part B & Part D: Phase 1, Double-Blind, Placebo-Controlled, 4-Part, Single- and Multiple-Ascending Dose Trial to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Pharmacodynamics of SPT-320 in Healthy Participants.
Secondary ID [1] 314365 0
SPT-320-2024-101
Universal Trial Number (UTN)
Trial acronym
Linked study record
This study is linked to the study noted in ACTRN12625000575437.

Health condition
Health condition(s) or problem(s) studied:
Anxiety 337360 0
Condition category
Condition code
Mental Health 333746 333746 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study evaluates the safety, tolerability, pharmacokinetics (PK), and preliminary pharmacodynamics of SPT-320 and agomelatine following single dose in healthy adult participants.
Part B – Single Ascending Dose (SAD)
Intervention: Single oral dose of SPT-320 (oprodrug of agomelatine) or placebo
Dose levels: As SPT-320 human exposure is unknown, the dose range and number of doses to be assessed are TBD , with a minimum dose of 1 mg and a maximum dose of 400 mg. The safety review committee will review ongoing data to determine dose decisions. Participants will be confined to the Clinical Research Unit for supervised dosing.
Design: Randomized, double-blind, placebo-controlled

Part D – Multiple Ascending Dose (MAD)
Intervention: Multiple oral doses of SPT-320 or placebo once daily for 7 days
Dose levels: As SPT-320 human exposure is unknown, the dose range and number of doses to be assessed are TBD, with a minimum dose of 1 mg and a maximum dose of 400 mg. The safety review committee will review ongoing data to determine dose decisions. Participants will be confined to the Clinical Research Unit for supervised dosing.
Design: Randomized, double-blind, placebo-controlled
Intervention code [1] 330983 0
Treatment: Drugs
Comparator / control treatment
Placebo-controlled (gelatine capsule).
Control group
Placebo

Outcomes
Primary outcome [1] 341371 0
Safety and tolerability - treatment-emergent adverse events [TEAs].
Timepoint [1] 341371 0
Safety and tolerability will be assessed daily during the inpatient period and at the Day 7 safety follow-up visit.
Secondary outcome [1] 447340 0
To evaluate the pharmacokinetics (PK) of SPT-320 key exposure parameters including Cmax, tmax, AUC.
Timepoint [1] 447340 0
Blood samples for pharmacokinetic analysis will be collected at the following timepoints relative to dose administration on Day 1 for Part B: pre-dose, and at .25, 0.5, .75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 7, 8, 10, 12, 16, 18, 24, 28, 32, 36, 48, and 72 hours post-dose.
Secondary outcome [2] 448632 0
To evaluate the pharmacokinetics (PK) of SPT-320 key exposure parameters including Cmax, tmax, AUC
Timepoint [2] 448632 0
Blood samples for pharmacokinetic analysis will be collected at the following timepoints relative to dose administration on Day 1 for Part D: pre-dose, and at .25, 0.5, .75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 7, 8, 10, 12, 16, 18, 24 hours post-dose. Additional timepoints include pre-dose through Day 6, pre-dose on Day 7 and at .25, 0.5, .75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 7, 8, 10, 12, 16, 18, 24, 28, 32, 36, 48, and 72 hours post-dose.

Eligibility
Key inclusion criteria
1. Male and female participants between the ages of 18 and 55 years, inclusive, at the time of signing the informed consent form.
2. Healthy participants, as determined by the absence of clinically relevant abnormalities in medical history, physical examination, vital signs, 12-lead electrocardiogram, and clinical laboratory tests, as evaluated by the investigator.
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Current or past history of significant cardiovascular, pulmonary, gastrointestinal, renal, hepatic, metabolic, genitourinary, endocrine (including diabetes mellitus, thyroid disorders), malignancy, hematological, immunological, neurological, or psychiatric disease.

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
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
31/07/2025
Actual
Date of last participant enrolment
Anticipated
30/06/2026
Actual
Date of last data collection
Anticipated
16/07/2026
Actual
Sample size
Target
124
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 318886 0
Commercial sector/Industry
Name [1] 318886 0
Seaport Therapeutics Australia Pty Ltd
Country [1] 318886 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Seaport Therapeutics Australia Pty Ltd
Address
Country
Australia
Secondary sponsor category [1] 321353 0
None
Name [1] 321353 0
Address [1] 321353 0
Country [1] 321353 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 317503 0
Bellberry Human Research Ethics Committee H
Ethics committee address [1] 317503 0
Ethics committee country [1] 317503 0
Australia
Date submitted for ethics approval [1] 317503 0
09/04/2025
Approval date [1] 317503 0
15/05/2025
Ethics approval number [1] 317503 0
2025-04-565

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

Contacts
Principal investigator
Name 141254 0
Dr Sepehr Shakib
Address 141254 0
CMAX Clinical Research Level 5, 18a North Terrace, Adelaide SA 5000, AUSTRALIA
Country 141254 0
Australia
Phone 141254 0
+61 0411 100 278
Fax 141254 0
Email 141254 0
[email protected]
Contact person for public queries
Name 141255 0
Sergey Yagoda
Address 141255 0
Seaport Therapeutics, 101 Seaport Blvd, Floor 12, Boston MA 02210
Country 141255 0
United States of America
Phone 141255 0
+16178074062
Fax 141255 0
Email 141255 0
[email protected]
Contact person for scientific queries
Name 141256 0
Sergey Yagoda
Address 141256 0
Seaport Therapeutics, 101 Seaport Blvd, Floor 12, Boston MA 02210
Country 141256 0
United States of America
Phone 141256 0
+16178074062
Fax 141256 0
Email 141256 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.