Study of AT-752 in Healthy Subjects

Dengue Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04722627
• Other study ID #: AT-02A-001
• Status: Completed
• Phase: Phase 1
• Start date: March 9, 2021
• Est. completion date: November 14, 2021

Study information

• Verified date: October 2022
• Source: Atea Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: November 14, 2021
• Est. primary completion date: November 14, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Dengue

Intervention

Drug:
• AT-752
Parallel Assignment
• Placebo
Parallel Assignment

Locations

Country	Name	City	State
Australia	Atea Study Site	Melbourne	Victoria

Sponsors (1)

Lead Sponsor	Collaborator
Atea Pharmaceuticals, Inc.

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportions (active vs. Placebo) of subjects experiencing treatment-emergent adverse events		Day 6 for single dose or Day 12 for multiple dose
Primary	Pharmacokinetics (PK) of AT-752 of single and multiple ascending oral doses	Maximum plasma concentration (Cmax)	Day 1 for subjects receiving a single fasted dose; Days 1 and 7 for subjects receiving multiple doses
Primary	Pharmacokinetics (PK) of AT-752 of single and multiple ascending oral doses	Area under the concentration-time curve (AUC)	Day 1 for subjects receiving a single fasted dose; Days 1 and 7 for subjects receiving multiple doses ]
Primary	Effect of food on Pharmacokinetics (PK) of AT-752 of a single oral dose	Maximum plasma concentration (Cmax)	Day 1 for subjects receiving a single fed dose]
Primary	Effect of food on Pharmacokinetics (PK) of AT-752 of a single oral dose	Area under the concentration-time curve (AUC)	Day 1 for subjects receiving a single fed dose ]