Study of AT-752 in Healthy Subjects

Atea Pharmaceuticals, Inc.65 enrolled

Overview

This study will assess the safety, tolerability and pharmacokinetics (PK) of AT-752 in healthy subjects

A First-in Human, Randomized, Double-blind, Placebo controlled Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of AT-752 in Healthy Subjects

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Dengue

Interventions

AT-752DRUG

Parallel Assignment

PlaceboDRUG

Parallel Assignment

Eligibility

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

Medical Language ↔ Plain English

Inclusion Criteria: 1. Body mass index (BMI) of 18-29 kg/m2 2. Must agree to use protocol-specified methods of contraception 3. Negative pregnancy test 4. Willing to comply with the study requirements and to provide written informed consent Exclusion Criteria: 1. Pregnant or breastfeeding 2. Abuse of alcohol or drugs 3. Use of other investigational drugs within 30 days of dosing 4. Other clinically significant medical conditions

Locations (1)

Atea Study Site

Melbourne, Victoria, Australia

Outcomes

Primary Outcomes

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

Time frame: Day 6 for single dose or Day 12 for multiple dose

Pharmacokinetics (PK) of AT-752 of single and multiple ascending oral doses

Maximum plasma concentration (Cmax)

Time frame: Day 1 for subjects receiving a single fasted dose; Days 1 and 7 for subjects receiving multiple doses

Pharmacokinetics (PK) of AT-752 of single and multiple ascending oral doses

Area under the concentration-time curve (AUC)

Time frame: Day 1 for subjects receiving a single fasted dose; Days 1 and 7 for subjects receiving multiple doses ]

Effect of food on Pharmacokinetics (PK) of AT-752 of a single oral dose

Maximum plasma concentration (Cmax)

Time frame: Day 1 for subjects receiving a single fed dose]

Effect of food on Pharmacokinetics (PK) of AT-752 of a single oral dose

Area under the concentration-time curve (AUC)

Time frame: Day 1 for subjects receiving a single fed dose ]

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.