Hepatitis CPhase 1/2NCT04309734
Study of AT-777 in Healthy Subjects and AT-777 in Combination With AT-527 in HCV-Infected Subjects
A Phase 1/2 study testing AT-777 and AT-527 in people with Hepatitis C and Hepatitis C, Chronic, run by Atea Pharmaceuticals, Inc. at 1 site in Belgium.
Trial summary
This study has two parts. Part A will assess the safety, tolerability and pharmacokinetics (PK) of AT-777 in healthy subjects. Part B will assess the safety, antiviral activity/efficacy and PK of AT-777 in combination with AT-527 after 8 weeks of treatment in HCV-infected subjects. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Hepatitis C, Hepatitis C, Chronic, Chronic Hepatitis C
- What is being tested?
- AT-777 and AT-527
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteBelgium
- Study dates
- Oct 2021to Sep 2022
- Phase
- Phase 1/2
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All:
- Body mass index (BMI) of 18-35 kg/m2
- Must agree to use protocol-specified methods of contraception
- Negative pregnancy test
- Willing to comply with the study requirements and to provide written informed consent
- Additional for Part A:
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- -18-55 years of age
- Additional for Part B:
- 18-65 years of age
- HCV genotype 1, 2 or 3
- Documented history compatible with chronic hepatitis C
- HCV RNA ≥ 10,000 IU/mL at Screening
Who cannot join
- All:
- Pregnant or breastfeeding
- Abuse of alcohol or drugs
- Use of other investigational drugs within 30 days of dosing
- Other clinically significant medical conditions
- Additional for Part B:
Show all 9Show fewer
- Prior exposure to any HCV NS5A inhibitor
- Cirrhosis
- Co-infection with hepatitis B virus or HIV
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I/IIa Study Assessing AT-777 in Healthy Subjects and AT-777 in Combination With AT-527 in HCV-Infected Subjects
This study has two parts. Part A will assess the safety, tolerability and pharmacokinetics (PK) of AT-777 in healthy subjects. Part B will assess the safety, antiviral activity/efficacy and PK of AT-777 in combination with AT-527 after 8 weeks of treatment in HCV-infected subjects.
- Conditions
- Hepatitis C, Hepatitis C, Chronic, Chronic Hepatitis C, Hepatitis C Virus Infection, HCV Infection
- Being tested
- AT-777, Placebo, AT-527
- Medical subject headings
- Hepatitis C, Hepatitis C, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AT-777Drug
Administered orally as one or two 60 mg capsule(s) of AT-777 (inhibitor of HCV nonstructural protein 5A (NS5A)), depending on the arm.
PlaceboDrug
Administered orally, as one or two placebo capsules, depending on the arm.
AT-527Drug
Administered orally as one 550 mg tablet of AT-527 (nucleotide prodrug inhibitor of HCV nonstructural protein 5B (NS5B) polymerase), depending on the arm.
| Study group | Role | What they receive |
|---|---|---|
| Part A - 60 mg AT-777 single dose | Experimental | Not described Receives: Drug: AT-777 |
| Part A - 120 mg AT-777 single dose | Experimental | Not described Receives: Drug: AT-777 |
| Part A - Placebo single dose | Placebo comparator | Not described Receives: Drug: Placebo |
| Part B - 60 mg AT-777 + 550 mg AT-527 once daily for 8 weeks | Experimental | Not described Receives: Drug: AT-777; Drug: AT-527 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment-Emergent Adverse Events
Number of subjects experiencing treatment-emergent adverse events
Measured: Through Day 6 for subjects in Part A
Incidence of Treatment-Emergent Adverse Events
Number of subjects experiencing treatment-emergent adverse events
Measured: Through 4 weeks after end of treatment for subjects in Part B
Antiviral Activity of AT-777 and AT-527
Number of subjects who achieve plasma HCV RNA < lower limit of quantitation (LLOQ) and target not detected (TND)
Measured: Through 2 weeks of treatment for subjects in Part B
Secondary outcomes (3)
AT-777 maximum plasma concentration (Cmax)
PK
Measured: Day 1 for subjects in Part A
AT-777 area under the concentration-time curve (AUC)
PK
Measured: Day 1 for subjects in Part A
Proportion of subjects achieving sustained virologic response (SVR)
SVR defined as the HCV RNA < lower limit of quantitation (LLOQ) at 12 weeks after end of treatment
Measured: 12 weeks after end of treatment for subjects in Part B
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2020
- Study startOct 2021 (estimated)
- Primary completionJun 2022 (estimated)
- Study completionSep 2022 (estimated)
Why it stopped: Withdrawn prior to study initiation.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis CStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Atea Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Xiao-Jian Zhou, Study director, Atea Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04309734
- Sponsor's protocol ID
- AT-01C-001
- Other IDs
- 2019-004997-24, 2019
- Status last verified
- Jun 2022
- First submitted
- 13 Mar 2020
- Last updated
- 8 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/IIa Study Assessing AT-777 in Healthy Subjects and AT-777 in Combination With AT-527 in HCV-Infected Subjects
- ClinicalTrials.gov ID
- NCT04309734
- Acronym / sponsor ID
- AT-01C-001
- Conditions
- Hepatitis C, Hepatitis C, Chronic, Chronic Hepatitis C, Hepatitis C Virus Infection, HCV Infection
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Withdrawn prior to study initiation.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Atea Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2021 (estimated)
- Primary completion
- Jun 2022 (estimated)
- Study completion
- Sep 2022 (estimated)
- First posted
- 16 Mar 2020 (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 has two parts. Part A will assess the safety, tolerability and pharmacokinetics (PK) of AT-777 in healthy subjects. Part B will assess the safety, antiviral activity/efficacy and PK of AT-777 in combination with AT-527 after 8 weeks of treatment in HCV-infected subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Part A - 60 mg AT-777 single dose | Experimental | Drug: AT-777 |
| Part A - 120 mg AT-777 single dose | Experimental | Drug: AT-777 |
| Part A - Placebo single dose | Placebo comparator | Drug: Placebo |
| Part B - 60 mg AT-777 + 550 mg AT-527 once daily for 8 weeks | Experimental | Drug: AT-777, Drug: AT-527 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Body mass index (BMI) of 18-35 kg/m2
- Must agree to use protocol-specified methods of contraception
- Negative pregnancy test
- Willing to comply with the study requirements and to provide written informed consent
- -18-55 years of age
Key exclusion criteria (9 listed)
- Pregnant or breastfeeding
- Abuse of alcohol or drugs
- Use of other investigational drugs within 30 days of dosing
- Other clinically significant medical conditions
- Prior exposure to any HCV NS5A inhibitor
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 |
|---|---|---|
| AT-777Administered orally as one or two 60 mg capsule(s) of AT-777 (inhibitor of HCV nonstructural protein 5A (NS5A)), depending on the arm. | Drug | Part A - 120 mg AT-777 single dose, Part A - 60 mg AT-777 single dose, Part B - 60 mg AT-777 + 550 mg AT-527 once daily for 8 weeks |
| PlaceboAdministered orally, as one or two placebo capsules, depending on the arm. | Drug | Part A - Placebo single dose |
| AT-527Administered orally as one 550 mg tablet of AT-527 (nucleotide prodrug inhibitor of HCV nonstructural protein 5B (NS5B) polymerase), depending on the arm. | Drug | Part B - 60 mg AT-777 + 550 mg AT-527 once daily for 8 weeks |
Primary outcome
Incidence of Treatment-Emergent Adverse Events
Time frame: Through Day 6 for subjects in Part A
Number of subjects experiencing treatment-emergent adverse events
Incidence of Treatment-Emergent Adverse Events
Time frame: Through 4 weeks after end of treatment for subjects in Part B
Number of subjects experiencing treatment-emergent adverse events
Antiviral Activity of AT-777 and AT-527
Time frame: Through 2 weeks of treatment for subjects in Part B
Number of subjects who achieve plasma HCV RNA < lower limit of quantitation (LLOQ) and target not detected (TND)
3 secondary outcomes
AT-777 maximum plasma concentration (Cmax)
Time frame: Day 1 for subjects in Part A
AT-777 area under the concentration-time curve (AUC)
Time frame: Day 1 for subjects in Part A
Proportion of subjects achieving sustained virologic response (SVR)
Time frame: 12 weeks after end of treatment for subjects in Part B
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2022.
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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.
Xiao-Jian Zhou study director
Atea Pharmaceuticals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing AT-777 and AT-527 in people with Hepatitis C and Hepatitis C, Chronic, run by Atea Pharmaceuticals, Inc. at 1 site in Belgium.
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 12 inclusion and 9 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: withdrawn, as of the sponsor's last update on 8 Jun 2022. 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 Belgium. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 was withdrawn before enrolling participants, so there are no results.
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?
Incidence of Treatment-Emergent Adverse Events (time frame: Through Day 6 for subjects in Part A). The study lists 3 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 8 Jun 2022.