Healthy Volunteer StudyPhase 1NCT05905497
The Study of Bemnifosbuvir in Healthy Japanese Subjects
A Phase 1 study testing Bemnifosbuvir (BEM) in people with Healthy Volunteer Study, run by Atea Pharmaceuticals, Inc. at 1 site in United States.
Trial summary
This study will assess the safety, tolerability and pharmacokinetics (PK) of Bemnifosbuvir in healthy adult Japanese subjects Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer Study
- What is being tested?
- Bemnifosbuvir (BEM)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Apr 2023to 19 May 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 64 years
- All sexes
- Healthy volunteers accepted
- 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
- The subject must have been born in Japan and have both parents and 4 grandparents of Japanese descent
- The subject must have lived outside of Japan for no more than 10 years
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 1, Open-Label, Multiple-Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Bemnifosbuvir in Healthy Adult Japanese Subjects
This study will assess the safety, tolerability and pharmacokinetics (PK) of Bemnifosbuvir in healthy adult Japanese subjects
- Conditions
- Healthy Volunteer Study
- Being tested
- Bemnifosbuvir (BEM)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bemnifosbuvir (BEM)Drug
Also called AT-527
BEM administered BID for 4 days and QD on Day 5 (9 consecutive doses)
| Study group | Role | What they receive |
|---|---|---|
| Bemnifosbuvir (BEM) | Experimental | oral tablet Receives: Drug: Bemnifosbuvir (BEM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics (PK) of BEM Maximum plasma concentration (Cmax)
Measured: Day 1, Day 5
Pharmacokinetics (PK) of BEM Area under the plasma concentration-time curve (AUC)
Measured: Day 1, Day 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2023
- Study start26 Apr 2023
- Primary completion19 May 2023
- Study completion19 May 2023
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Atea Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05905497
- Sponsor's protocol ID
- AT-03A-018
- Status last verified
- Jun 2023
- First submitted
- 20 Apr 2023
- Last updated
- 15 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-Label, Multiple-Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Bemnifosbuvir in Healthy Adult Japanese Subjects
- ClinicalTrials.gov ID
- NCT05905497
- Acronym / sponsor ID
- AT-03A-018
- Conditions
- Healthy Volunteer Study
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Atea Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 26 Apr 2023 (actual)
- Primary completion
- 19 May 2023 (actual)
- Study completion
- 19 May 2023 (actual)
- First posted
- 15 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will assess the safety, tolerability and pharmacokinetics (PK) of Bemnifosbuvir in healthy adult Japanese subjects
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bemnifosbuvir (BEM) | Experimental | Drug: Bemnifosbuvir (BEM)oral tablet |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
- The subject must have been born in Japan and have both parents and 4 grandparents of Japanese descent
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bemnifosbuvir (BEM)Also: AT-527BEM administered BID for 4 days and QD on Day 5 (9 consecutive doses) | Drug | Bemnifosbuvir (BEM) |
Primary outcome
Pharmacokinetics (PK) of BEM Maximum plasma concentration (Cmax)
Time frame: Day 1, Day 5
Pharmacokinetics (PK) of BEM Area under the plasma concentration-time curve (AUC)
Time frame: Day 1, Day 5
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Bemnifosbuvir (BEM) in people with Healthy Volunteer Study, run by Atea Pharmaceuticals, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacokinetics (PK) of BEM Maximum plasma concentration (Cmax) (time frame: Day 1, Day 5). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2023.