Study of AT-527 in Healthy Subjects Under Fasting Conditions or With a Meal
Phase 1, Multiple Dose, Randomized, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of AT-527 Following Oral Administration Under Fasting Conditions or With a Meal in Healthy Adult Subjects
1 other identifier
interventional
136
1 country
1
Brief Summary
This study will assess the safety, tolerability and pharmacokinetics (PK) of AT-527 following oral administration under fasting conditions or with a meal in healthy adult subjects
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Feb 2022
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 16, 2022
CompletedStudy Start
First participant enrolled
February 22, 2022
CompletedFirst Posted
Study publicly available on registry
February 25, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 23, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
August 23, 2022
CompletedOctober 18, 2022
October 1, 2022
6 months
February 16, 2022
October 14, 2022
Conditions
Outcome Measures
Primary Outcomes (4)
Pharmacokinetics (PK) of AT-527
Maximum plasma concentration (Cmax)
Day 1
Pharmacokinetics (PK) of AT-527
Area under the concentration-time curve (AUC)
Day 1
Pharmacokinetics (PK) of AT-527
Trough plasma concentration (Ctrough)
Day 1
Proportions of subjects experiencing treatment-emergent adverse events
Day 1-10
Study Arms (4)
AT-527
EXPERIMENTALPlacebo
PLACEBO COMPARATORAT-527 BID
EXPERIMENTALAT-527 single dose fasted/fed
EXPERIMENTALInterventions
AT-527 administered twice daily (BID) for 5 days fasted
Matching placebo administered twice daily (BID) for 5 days fasted
AT-527 administered twice daily (BID) for 5 days fed
AT-527 single dose fasted/fed cross-over
Eligibility Criteria
You may qualify if:
- Must agree to use two methods of birth control from Screening through 90 days after administration of the last dose of study drug
- Females must have a negative pregnancy test at Screening and prior to dosing
- Minimum body weight of 50 kg and body mass index (BMI) of 18-32 kg/m2
- Willing to comply with the study requirements and to provide written informed consent
You may not qualify if:
- Pregnant or breastfeeding
- Infected with hepatitis B virus, hepatitis C virus, HIV or COVID-19
- Abuse of alcohol or drugs
- Use of other investigational drugs within 28 days of dosing
- Other clinically significant medical conditions or laboratory abnormalities
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Atea Study Site
Québec, Montreal, Quebec, Canada
MeSH Terms
Interventions
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 16, 2022
First Posted
February 25, 2022
Study Start
February 22, 2022
Primary Completion
August 23, 2022
Study Completion
August 23, 2022
Last Updated
October 18, 2022
Record last verified: 2022-10