NCT04877769

Brief Summary

This study will assess the safety, tolerability and bronchopulmonary pharmacokinetics (PK) of AT-527 (R07496998)

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Apr 2021

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 25, 2021

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

May 4, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 7, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2021

Completed
Last Updated

February 25, 2022

Status Verified

April 1, 2021

Enrollment Period

4 months

First QC Date

May 4, 2021

Last Update Submit

February 23, 2022

Conditions

Healthy Volunteer Study

Outcome Measures

Primary Outcomes (1)

  • Concentrations of AT-527 in epithelial lining fluid

    4-5 hours after last dose and 11-12 hours after last dose

Study Arms (3)

AT-527 Group A

EXPERIMENTAL

n=8

Drug: AT-527

AT-527 Group B

EXPERIMENTAL

n=8

Drug: AT-527

AT-527 Group C

EXPERIMENTAL

n=8

Drug: AT-527

Interventions

AT-527DRUG

administered twice daily (BID) for 2.5 days (5 doses in total)

Also known as: RO7496998
AT-527 Group AAT-527 Group BAT-527 Group C

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects must agree to use birth control, as required by the protocol.
  • 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 18-29 kg/m2
  • Willing to comply with the study requirements and to provide written informed consent

You may not qualify if:

  • Infected with hepatitis B virus, hepatitis C virus, HIV or SARS-CoV-2
  • Abuse of alcohol or drugs
  • Use of other investigational drugs within 28 days of dosing
  • Concomitant use of prescription medications, or systemic over-the-counter medications
  • Other clinically significant medical conditions or laboratory abnormalities

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Atea Study Site

London, NW10 7EW, United Kingdom

Location

MeSH Terms

Interventions

AT-511

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 4, 2021

First Posted

May 7, 2021

Study Start

April 25, 2021

Primary Completion

August 31, 2021

Study Completion

August 31, 2021

Last Updated

February 25, 2022

Record last verified: 2021-04

Locations

GB(1)