Study of AT-587 in Healthy Subjects

Phase 1RecruitingNCT07728487

Atea Pharmaceuticals, Inc.62 enrolled

Overview

This study will assess the safety, tolerability and pharmacokinetics (PK) of AT-587 in healthy subjects

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Hepatitis E

Interventions

AT-587DRUG

Parallel Assignment

PlaceboOTHER

Parallel Assignment

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Atea Study Site

Edegem, Belgium

RECRUITING

Outcomes

Primary Outcomes

Proportions (active vs. Placebo) of subjects experiencing treatment-emergent adverse events

Time frame: Day 1 up to Day 13

Secondary Outcomes

Pharmacokinetics (PK) of AT-587 (Cmax)

Maximum plasma concentration (Cmax)

Time frame: Day 1 up to Day 13

Pharmacokinetics (PK) of AT-587 (AUC)

Area under the concentration-time curve (AUC)

Time frame: Day 1 up to Day 13

Central Contacts

Clinical Trials Administrator

CONTACT

888-481-1607 AteaClinicalTrials@ateapharma.com

Data from ClinicalTrials.gov

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