Safety and Pharmacokinetic Evaluation of Single and Multiple Oral Doses of AT-587 in Healthy Adults for Treatment of Chronic Hepatitis E Virus Infection

The primary objective is to assess the safety of AT-587 and to characterize its pharmacokinetic profile following single and multiple oral administrations in healthy adults, a population relevant to the treatment of chronic hepatitis E virus infection. This evaluation is intended to determine tolerability and systemic exposure parameters that are essential for subsequent clinical development.

The trial enrolled healthy volunteers of both sexes, encompassing adults aged 18 years and older, including older adults, as indicated by the age‑range codes. Participants were required to have documented chronic hepatitis E virus infection and were classified as a vulnerable population. The sponsor did not provide information on the total number of participants. Selection criteria emphasized the presence of chronic HEV infection, adult age, and inclusion of both female and male subjects, while allowing enrollment of individuals considered vulnerable. No specific lifestyle restrictions such as diet or physical activity were reported.

The study is a Phase 1, single‑center, open‑label trial evaluating the safety, tolerability, and pharmacokinetics of single and multiple oral doses of AT‑587 in healthy adults, with an estimated recruitment period from 2026‑07‑06 to 2026‑11‑25. After an initial screening visit to confirm eligibility, participants receive the assigned dose and undergo serial blood sampling for drug‑level assessment, followed by scheduled follow‑up visits on days 2, 7, 14, and 28 to monitor adverse events, vital signs, and laboratory parameters. The trial concludes with an end‑of‑study visit at approximately day 56, at which final safety evaluations are performed. Total participant involvement is expected to span roughly eight weeks. Early termination may occur if a participant experiences a serious adverse event, fails to meet compliance requirements, or withdraws consent.

Efficacy of the investigational product in participants with chronic hepatitis E virus (HEV) infection will be assessed in accordance with the predefined protocol criteria.