This Phase 1 study in healthy adult volunteers is planned to evaluate the safety, tolerability, and pharmacokinetics (PK) of AV078, a selective inhibitor of mammalian target of rapamycin complex 1 (mTORC1). The study will begin with a standard exploration of safety and tolerability in sequential single ascending dose (SAD) and multiple ascending dose (MAD) cohorts. Subsequent cohorts will collect PK data to evaluate food effects and potential drug-drug interactions relevant to AV078.
Age range
18 Years – 65 Years
Sex
ALL
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Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Incidence and severity of treatment emergent adverse events (TEAEs).
Timeframe: From screening (Day -42) to final visit post-treatment (Day 14 for Part A and Day 42 for Part B).
Occurrence of clinically significant changes in physical examination (including neurological assessment).
Timeframe: From screening (Day -42) to final visit post-treatment (Day 14 for Part A and Day 42 for Part B).
Change in blood haematology values.
Timeframe: From screening (Day -42) to final visit post-treatment (Day 14 for Part A and Day 42 for Part B).
Change in blood biochemisty values.
Timeframe: From screening (Day -42) to final visit post-treatment (Day 14 for Part A and Day 42 for Part B).
Change in urinalysis values.
Timeframe: From screening (Day -42) to final visit post-treatment (Day 14 for Part A and Day 42 for Part B).
Change in lipid panel values.
Timeframe: From screening (Day -42) to final visit post-treatment (Day 14 for Part A and Day 42 for Part B).
Change in blood coagulation values.
Timeframe: From screening (Day -42) to final visit post-treatment (Day 14 for Part A and Day 42 for Part B).
Clinically significant ECG findings.
Timeframe: From screening (Day -42) to final visit post-treatment (Day 14 for Part A and Day 42 for Part B).
Monitor for the emergence of suicidal ideation and behaviour using the Columbia-Suicide Severity Rating Scale (C-SSRS).
Timeframe: From screening (Day -42) to final visit post-treatment (Day 14 for Part A and Day 42 for Part B).
Pharmacokinetics measured by area under the concentration-time curve in fasted and fed state.
Timeframe: Day 1 to Day 7 post-dose and final follow-up visit (Day 14)
Pharmacokinetics measured by the maximum plasma concentration (Cmax) in fasted and fed state.
Timeframe: Day 1 to Day 7 post-dose and final follow-up visit (Day 14)
Effects of itraconazole on the pharmacokinetics of AV078 measured by area under the concentration-time curve.
Timeframe: Day 1 to Day 15 post-dose and final follow-up visit (Day 23)
Effects of itraconazole on the pharmacokinetics of AV078 measured by the maximum plasma concentration (Cmax).
Timeframe: Day 1 to Day 15 post-dose and final follow-up visit (Day 23)
Effects of AV078 on the pharmacokinetics of midazolam and fexofenadine measured by area under the concentration-time curve.
Timeframe: Day 1, 2, 18 and 19 post-dose (midazolam) or Day 1-3, 18 and 19 post-dose (fexofenadine)
Effects of AV078 on the pharmacokinetics of midazolam and fexofenadine measured by the maximum plasma concentration (Cmax).
Timeframe: Day 1, 2, 18 and 19 post-dose (midazolam) or Day 1-3, 18 and 19 post-dose (fexofenadine)