Healthy Volunteer StudyPhase 1NCT04877769
Bronchopulmonary PK of AT-527 (R07496998)
A Phase 1 study testing AT-527 in people with Healthy Volunteer Study, run by Atea Pharmaceuticals, Inc. at 1 site in United Kingdom.
Trial summary
This study will assess the safety, tolerability and bronchopulmonary pharmacokinetics (PK) of AT-527 (R07496998) Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer Study
- What is being tested?
- AT-527
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 25 Apr 2021to 31 Aug 2021
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Open-label, Randomized Study in Healthy Subjects to Assess the Bronchopulmonary Pharmacokinetics, Safety and Tolerability of AT-527, a Potential Treatment for COVID-19
This study will assess the safety, tolerability and bronchopulmonary pharmacokinetics (PK) of AT-527 (R07496998)
- Conditions
- Healthy Volunteer Study
- Being tested
- AT-527
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AT-527Drug
Also called RO7496998
administered twice daily (BID) for 2.5 days (5 doses in total)
| Study group | Role | What they receive |
|---|---|---|
| AT-527 Group A | Experimental | n=8 Receives: Drug: AT-527 |
| AT-527 Group B | Experimental | n=8 Receives: Drug: AT-527 |
| AT-527 Group C | Experimental | n=8 Receives: Drug: AT-527 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concentrations of AT-527 in epithelial lining fluid
Measured: 4-5 hours after last dose and 11-12 hours after last dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2021
- Study start25 Apr 2021
- Primary completion31 Aug 2021
- Study completion31 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Volunteer StudyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Atea Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Hoffmann-La Roche
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04877769
- Sponsor's protocol ID
- AT-03A-007
- Status last verified
- Apr 2021
- First submitted
- 4 May 2021
- Last updated
- 25 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No