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Completed

NCT Number: NCT04722627

Study of AT-752 in Healthy Subjects

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

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Key information

Conditions

Dengue Arbovirus Infections Flaviviridae Infections Flavivirus Infections Hemorrhagic Fevers, Viral Infections Mosquito-Borne Diseases RNA Virus Infections Vector Borne Diseases Virus Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Atea Study Site

Melbourne, Victoria, 3004, Australia

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AT-752

Drug

Parallel Assignment

Placebo

Drug

Parallel Assignment

Primary outcomes

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

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

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

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

    Maximum plasma concentration (Cmax)

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

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

    Area under the concentration-time curve (AUC)

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

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

    Maximum plasma concentration (Cmax)

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

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

    Area under the concentration-time curve (AUC)

Sponsors and collaborators

Lead sponsor

Atea Pharmaceuticals, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jan 25, 2021
Registry last updated
Oct 17, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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