Assessment of the Safety, Tolerability and Pharmacokinetics of AV078 in Healthy Volunteers

NCT06205381 ↗

Phase 1 Completed 89 enrolled Aeovian Pharmaceuticals, Inc.

RandomizedSequentialTriple-blindTreatment

Summary

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.

Timeline

Start: 2024-01-31
Primary completion: 2025-02-08
Completion: 2025-02-08

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	AV078	Unknown	0.5 mg	Oral
Subject	Fexofenadine	Unknown	120 mg	Oral
Subject	Itraconazole	Small molecule	200 mg	Oral
Subject	Midazolam	Small molecule	2.5 mg	Oral

Indications

No indication recorded.