Part B & Part D: Phase I Single and Multiple-Ascending Dose Trial of SPT-320 in Healthy Participants
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.
Seaport Therapeutics Australia Pty Ltd
139 participants
Jul 29, 2025
Interventional
Conditions
Summary
This is a Phase 1, four-part clinical trial in healthy adult participants to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of SPT-320, an investigational oral prodrug of agomelatine. Part B evaluates single ascending doses of SPT-320 compared with placebo. Part D studies multiple ascending doses of SPT-320 given once daily for 7 days, compared with placebo.
Eligibility
Inclusion Criteria2
- Male and female participants between the ages of 18 and 55 years, inclusive, at the time of signing the informed consent form.
- 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.
Exclusion Criteria1
- 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.
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Interventions
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
Locations(1)
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ACTRN12625000685415