Status:
COMPLETED
Assessment of the Safety, Tolerability and Pharmacokinetics of AV078 in Healthy Volunteers
Lead Sponsor:
Aeovian Pharmaceuticals, Inc.
Conditions:
Healthy Participants
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief 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 (mT...
Detailed Description
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 (mT...
Eligibility Criteria
Inclusion
- Key
- Healthy male or female as determined by medical evaluation including medical history, psychiatric history, and no clinically significant findings on physical examination, laboratory tests, and cardiac monitoring. Slight excursions outside of normal limits may be allowed provided they are considered not clinically significant by the investigator.
- Ages 18-65 years (inclusive), at the time of consent.
- At least 45 kg with a body mass index (BMI; Quetelet index) in the range 18.0-32.0, at screening.
- Sufficient intelligence to understand the nature of the trial and any hazards of participating in it. Ability to communicate satisfactorily with the investigator and to participate in, and comply with the requirements of, the entire trial.
- Willingness to give written consent to participate after reading the information and consent form, and after having the opportunity to discuss the trial with the investigator or their delegate.
- Agree not to donate blood or blood products during the study and for up to 3 months after the last administration of the trial medication.
- Have received at least 2 doses of the COVID vaccine (1 dose of the Janssen-Cilag vaccine is acceptable).
- Key
Exclusion
- Current, or past history of any clinically significant mental or physical illness or condition that the Investigator concludes would create significant concern for participation in the study.
- Surgery (eg stomach bypass) or medical condition that might affect absorption of medicines (cholecystectomy is allowed).
- Presence or history of severe adverse reaction to any drug or a history of sensitivity to midazolam (Part E only), fexofenadine (Part E only) and itraconazole (Part D only), or any excipients in the tablets/solutions.
- History of relevant atopy including any confirmed significant allergic reactions against any drug, or multiple drug allergies (non-active hay fever is acceptable)
- History of suicidal behaviour or express or have any suicidal ideation on the C-SSRS at screening or admission.
- Employee of the Sponsor, the CRO and/or study site or their relatives.
- Unable or unwilling to eat a high-fat breakfast per study requirements (Part C only).
Key Trial Info
Start Date :
January 31 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 8 2025
Estimated Enrollment :
89 Patients enrolled
Trial Details
Trial ID
NCT06205381
Start Date
January 31 2024
End Date
February 8 2025
Last Update
March 26 2025
Active Locations (2)
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1
Q-Pharm
Herston, Queensland, Australia, 4006
2
Nucleus Network Pty Ltd
Melbourne, Victoria, Australia, 3220