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

NCT06205381 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 89

Last updated 2025-03-26

No results posted yet for this study

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.

Conditions

  • Healthy Participants

Interventions

DRUG

AV078

Oral solution containing active ingredient, AV078

DRUG

Placebo

Oral solution with no active ingredients

DRUG

Itraconazole

Once daily oral dose of 200 mg itraconazole administered for 9 days

DRUG

Midazolam

2.5 mg midazolam administered orally on day 1 and day 18

DRUG

Fexofenadine

120 mg fexofenadine administered orally on day 1 and day 18

Sponsors & Collaborators

  • Aeovian Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Davis Ryman · Chief Medical Officer, Aeovian Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

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

Countries

  • Australia

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06205381 on ClinicalTrials.gov