CompletedPhase 1

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

Australia89 participantsStarted 2024-01-31

Plain-language 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.

Who can participate

Age range18 Years – 65 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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).

Exclusion criteria

✕. 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).

What they're measuring

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).

Trial details

NCT IDNCT06205381

SponsorAeovian Pharmaceuticals, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-02-08

View on ClinicalTrials.gov More Healthy Participants trials

Plain-language summary

Who can participate

Age range18 Years – 65 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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).

Exclusion criteria

✕. 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).

What they're measuring

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).