> Trialight public data. Index of pages: https://trialight.com/llms.txt
> Web page: https://trialight.com/data/trial/study-of-at-527-in-healthy-subjects-under-fasting-conditions-0a04063a-0696-46bf-9560-5549fce23c20
> Record changed: 2026-11-04

# Study of AT-527 in Healthy Subjects Under Fasting Conditions or With a Meal

NCT05256732

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05256732)

Phase

Phase 1

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05256732)

Recruitment status

Completed

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05256732)

Participants

136

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05256732)

Lead sponsor

Atea Pharmaceuticals, Inc.

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05256732)

Start date

2022-02-22

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05256732)

Number of sites

1

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05256732)

## Title and summary

**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

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05256732)

**Short title**

Study of AT-527 in Healthy Subjects Under Fasting Conditions or With a Meal

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05256732)

**Official title**

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

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05256732)

## Status and phase

**Control arm**

Placebo

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05256732)

**Registry reports results**

No

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05256732)

**Listing at source**

Listed

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05256732)

**Recruitment status**

Completed

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05256732)

**Phase**

Phase 1

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05256732)

**Study type**

Interventional

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05256732)

## Dates

**Completion date**

2022-08-23

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05256732)

**First posted**

2022-02-25

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05256732)

**Registry last updated**

2022-10-18

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05256732)

**Primary completion date**

2022-08-23

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05256732)

**Start date**

2022-02-22

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05256732)

## Size and sites

**Actual participants**

136

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05256732)

**Participants**

136

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05256732)

**Participant count basis**

Actual

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05256732)

**Protocol amendments**

1

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05256732)

**Number of sites**

1

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05256732)

## Sponsor and oversight

**Data monitoring committee**

No

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05256732)

**Registry sponsor category**

Industry

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05256732)

**Lead sponsor**

Atea Pharmaceuticals, Inc.

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05256732)

**Source registry**

ClinicalTrials.gov

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05256732)

## Identifiers

**Registry ID**

NCT05256732

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05256732)

**ClinicalTrials.gov ID**

NCT05256732

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05256732)

**Registry record**

Open registry record

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05256732)

## Study design

**Allocation**

Randomised

**Model**

Parallel groups

**Purpose**

Treatment

**Masking**

Triple masking

**Masked roles**

Participants, Care providers, Investigators

Sources for study design

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05256732)

## Outcomes

### Primary outcomes

1. Pharmacokinetics (PK) of AT-527  
Timeframe: Day 1  
Maximum plasma concentration (Cmax)
2. Pharmacokinetics (PK) of AT-527  
Timeframe: Day 1  
Area under the concentration-time curve (AUC)
3. Pharmacokinetics (PK) of AT-527  
Timeframe: Day 1  
Trough plasma concentration (Ctrough)
4. Proportions of subjects experiencing treatment-emergent adverse events  
Timeframe: Day 1-10

Sources for outcomes

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05256732)

## Eligibility

**Sex**

All

**Age groups**

Adults, Older adults

**Minimum age**

18 Years

**Maximum age**

65 Years

**Healthy volunteers**

Yes

### Inclusion criteria

- 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

### Exclusion criteria

- 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

Sources for eligibility

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05256732)

## Sites

- Atea Study SiteQuébec, Canada

Sources for sites

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05256732)

## Related records

### Drugs (1)

- [Bemnifosbuvir sulfate](https://trialight.com/data/asset/bemnifosbuvir-sulfate-c698e97e-2daf-46cb-8abb-2c12e4bb6288.md)

### Lead sponsors (1)

- [Atea Pharmaceuticals, Inc.](https://trialight.com/data/company/atea-pharmaceuticals-inc-527d0102-265b-441c-8970-d0294f7ee688.md)

---

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