Study of AT-587 in Healthy Subjects
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: AT-587, Placebo.
- Who it may be relevant to
- Registry conditions: Hepatitis E. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Belgium
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Phase 1, First-in-Human (FIH), Single-center, Randomized, Double-blind, Placebo-controlled, Single and Multiple Ascending Dose Trial to Evaluate the Safety, Tolerability, and Pharmacokinetics (PK) of AT-587 in Healthy Adult Participants
Overview
This study will assess the safety, tolerability and pharmacokinetics (PK) of AT-587 in healthy subjects
Detailed description
A Phase 1, First-in-Human (FIH), Single-center, Randomized, Double-blind, Placebo-controlled, Single and Multiple Ascending Dose Trial to Evaluate the Safety, Tolerability, and Pharmacokinetics (PK) of AT-587 in Healthy Adult Participants
Interventions
- Drug AT-587
Parallel Assignment - Other Placebo
Parallel Assignment
Primary outcome measures
- Proportions (active vs. Placebo) of subjects experiencing treatment-emergent adverse events [Time frame: Day 1 up to Day 13]
Secondary outcome measures (2)
- Pharmacokinetics (PK) of AT-587 (Cmax) [Time frame: Day 1 up to Day 13]
- Pharmacokinetics (PK) of AT-587 (AUC) [Time frame: Day 1 up to Day 13]
Eligibility criteria
Inclusion criteria
- Body mass index (BMI) of 18-29 kg/m2
- Must agree to use protocol-specified methods of contraception
- Negative pregnancy test
- Willing to comply with the study requirements and to provide written informed consent
Exclusion criteria
- Pregnant or breastfeeding
- Abuse of alcohol or drugs
- Use of other investigational drugs within 30 days of dosing
- Other clinically significant medical conditions
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Sequential
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
Belgium · 1 center
- Atea Study Site — Edegem
Identifiers
NCT: NCT07728487 · AT-05E-001