Dengue
Conditions
Brief summary
This study will assess the safety, tolerability and pharmacokinetics (PK) of AT-752 in healthy subjects
Detailed 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
Interventions
DRUGAT-752
Parallel Assignment
DRUGPlacebo
Parallel Assignment
Sponsors
Atea Pharmaceuticals, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportions (active vs. Placebo) of subjects experiencing treatment-emergent adverse events | Day 6 for single dose or Day 12 for multiple dose | — |
| Pharmacokinetics (PK) of AT-752 of single and multiple ascending oral doses | Day 1 for subjects receiving a single fasted dose; Days 1 and 7 for subjects receiving multiple doses | Maximum plasma concentration (Cmax) |
| Effect of food on Pharmacokinetics (PK) of AT-752 of a single oral dose | Day 1 for subjects receiving a single fed dose] | Maximum plasma concentration (Cmax) |
Countries
Australia
Outcome results
None listed