Healthy Volunteer StudyPhase 1NCT04711187
Study of AT-527 in Healthy Subjects (R07496998)
A Phase 1 study testing AT-527 Formulation 1 and AT-527 Formulation 2 in people with Healthy Volunteer Study, run by Atea Pharmaceuticals, Inc. at 1 site in Canada.
Trial summary
This study will assess the safety, tolerability and pharmacokinetics (PK) of AT-527 in healthy subjects. 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 Formulation 1 and AT-527 Formulation 2
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 81 participants
- Where
- 1 siteCanada
- Study dates
- 2 Nov 2020to 15 Sep 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
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I Study Assessing the Safety and Pharmacokinetics of Multiple Doses of AT-527 in Healthy Subjects
This study will assess the safety, tolerability and pharmacokinetics (PK) of AT-527 in healthy subjects.
- Conditions
- Healthy Volunteer Study
- Being tested
- AT-527 Formulation 1, Placebo Comparator, AT-527 Formulation 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AT-527 Formulation 1Drug
AT-527 Formulation 1 (R07496998)
Placebo ComparatorOther
Placebo Comparator
AT-527 Formulation 2Drug
AT-527 Formulation 2 (R07496998)
| Study group | Role | What they receive |
|---|---|---|
| AT-527 Formulation 1 Dose 1 | Experimental | Not described Receives: Drug: AT-527 Formulation 1; Other: Placebo Comparator |
| AT-527 Formulation 2 Dose 1 | Experimental | Not described Receives: Drug: AT-527 Formulation 2 |
| AT-527 Formulation 2 Dose 2 | Experimental | Not described Receives: Other: Placebo Comparator; Drug: AT-527 Formulation 2 |
| AT-527 Formulation 1 Dose 3 | Experimental | Not described Receives: Drug: AT-527 Formulation 1; Other: Placebo Comparator |
| AT-527 Formulation 2 Dose 3 | Experimental | Not described Receives: Other: Placebo Comparator; Drug: AT-527 Formulation 2 |
| AT-527 Formulation 2 Dose 1 Fast/Fed | Experimental | Not described Receives: Drug: AT-527 Formulation 2 |
| AT-527 Formulation 2 Dose 3 Fast/Fed | Experimental | Not described Receives: Drug: AT-527 Formulation 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportions (active vs. placebo) of subjects experiencing treatment-emergent adverse events.
Measured: Day 10
Secondary outcomes (2)
Pharmacokinetics (PK) of AT-527
Maximum plasma concentration (Cmax)
Measured: Days 1 and 5
Pharmacokinetics (PK) of AT-527
Area under the concentration-time curve (AUC)
Measured: Days 1 and 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2021
- Study start2 Nov 2020
- Primary completion15 Sep 2021
- Study completion15 Sep 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 81 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
- NCT04711187
- Sponsor's protocol ID
- AT-03A-002
- Status last verified
- Jul 2021
- First submitted
- 13 Jan 2021
- Last updated
- 25 Feb 2022
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No