Chronic Hepatitis CPhase 1NCT03219957
Study of AT-527 in Healthy and HCV-Infected Subjects
A Phase 1 study testing AT-527 in people with Chronic Hepatitis C and Hepatitis C, run by Atea Pharmaceuticals, Inc. at 2 sites in 2 countries.
Trial summary
This study has multiple parts. It will assess the safety, tolerability and pharmacokinetics (PK) of AT-527 in healthy subjects and subjects infected with hepatitis C virus (HCV). In addition, the study will assess the antiviral activity of AT-527 in subjects infected with HCV. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Hepatitis C, Hepatitis C, Hepatitis C, Chronic
- What is being tested?
- AT-527
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 88 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 6 Jul 2017to 20 Jun 2018
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All subjects (healthy and HCV-infected subjects):
- Must agree to use two methods of birth control from Screening through 90 days after administration of the last dose of study drug
- Must have a negative pregnancy test at Screening and prior to dosing
- Minimum body weight of 50 kg
- Willing to comply with the study requirements and to provide written informed consent
- Additional inclusion criteria for HCV-infected subjects:
Show all 9Show fewer
- Must have not received prior treatment for HCV infection
- Documented clinical history compatible with chronic HCV infection
- Plasma HCV RNA ≥ 5.0 log10 IU/mL at Screening.
Who cannot join
- All subjects (healthy and HCV-infected subjects):
- Pregnant or breastfeeding
- Infected with hepatitis B virus or HIV
- 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
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: A Phase I Study Assessing Single and Multiple Doses of AT-527 in Healthy and HCV-Infected Subjects
This study has multiple parts. It will assess the safety, tolerability and pharmacokinetics (PK) of AT-527 in healthy subjects and subjects infected with hepatitis C virus (HCV). In addition, the study will assess the antiviral activity of AT-527 in subjects infected with HCV.
- Conditions
- Chronic Hepatitis C, Hepatitis C, Hepatitis C, Chronic
- Being tested
- AT-527, Placebo Comparator
- Keywords
- HCV, Hepatitis C Virus, RNA Viruses, Flavivirus, Liver Diseases, Hepatitis, Viral, Human, Flaviviridae Infections
- Medical subject headings
- Hepatitis C, Chronic, Hepatitis C, Liver Diseases, Hepatitis, Viral, Human, Flaviviridae Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AT-527Drug
Ascending doses of AT-527 administered orally.
Placebo ComparatorOther
Matching placebo
| Study group | Role | What they receive |
|---|---|---|
| AT-527 | Experimental | Not described Receives: Drug: AT-527 |
| Placebo | Placebo comparator | Not described Receives: Other: Placebo Comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Number of subjects experiencing treatment-emergent adverse events
Measured: Through Day 6 for subjects receiving a single dose
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Number of subjects experiencing treatment-emergent adverse events
Measured: Through Day 35 for subjects receiving multiple doses.
Secondary outcomes (3)
Pharmacokinetics (PK) of AT-527
Maximum plasma concentration (Cmax)
Measured: Day 1 for subjects receiving a single dose; Days 1 and 7 for subjects receiving multiple doses
Pharmacokinetics (PK) of AT-527
Area under the concentration-time curve (AUC)
Measured: Day 1 for subjects receiving a single dose; Days 1 and 7 for subjects receiving multiple doses
Antiviral Activity of AT-527
Change from baseline in plasma HCV RNA
Measured: Through Day 6 for subjects receiving a single dose; Through Day 35 for subjects receiving multiple doses.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2017
- Study start6 Jul 2017
- Primary completion20 Jun 2018
- Study completion20 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Atea Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Xiao-Jian Zhou, PhD, Study director, Atea Pharmaceuticals, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03219957
- Sponsor's protocol ID
- AT-01B-001
- Status last verified
- Feb 2020
- First submitted
- 13 Jul 2017
- Last updated
- 18 Feb 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Berliba E, Bogus M, Vanhoutte F, Berghmans PJ, Good SS, Moussa A, Pietropaolo K, Murphy RL, Zhou XJ, Sommadossi JP. Safety, pharmacokinetics and antiviral activity of AT-527, a novel purine nucleotide prodrug, in HCV-infected subjects with and without cirrhosis. Antimicrob Agents Chemother. 2019 Sep 9;63(12):e01201-19. doi: 10.1128/AAC.01201-19. Epub 2019 Sep 30.
PubMed 31570394
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study Assessing Single and Multiple Doses of AT-527 in Healthy and HCV-Infected Subjects
- ClinicalTrials.gov ID
- NCT03219957
- Acronym / sponsor ID
- AT-01B-001
- Conditions
- Chronic Hepatitis C, Hepatitis C, Hepatitis C, Chronic
- Keywords
- HCV, Hepatitis C Virus, RNA Viruses, Flavivirus, Liver Diseases, Hepatitis, Viral, Human, Flaviviridae Infections
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Atea Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 6 Jul 2017 (actual)
- Primary completion
- 20 Jun 2018 (actual)
- Study completion
- 20 Jun 2018 (actual)
- First posted
- 18 Jul 2017 (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 multiple parts. It will assess the safety, tolerability and pharmacokinetics (PK) of AT-527 in healthy subjects and subjects infected with hepatitis C virus (HCV). In addition, the study will assess the antiviral activity of AT-527 in subjects infected with HCV.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AT-527 | Experimental | Drug: AT-527 |
| Placebo | Placebo comparator | Other: Placebo Comparator |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Must agree to use two methods of birth control from Screening through 90 days after administration of the last dose of study drug
- Must have a negative pregnancy test at Screening and prior to dosing
- Minimum body weight of 50 kg
- Willing to comply with the study requirements and to provide written informed consent
- Must have not received prior treatment for HCV infection
Key exclusion criteria (6 listed)
- Pregnant or breastfeeding
- Infected with hepatitis B virus or HIV
- 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 |
|---|---|---|
| AT-527Ascending doses of AT-527 administered orally. | Drug | AT-527 |
| Placebo ComparatorMatching placebo | Other | Placebo |
Primary outcome
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Time frame: Through Day 6 for subjects receiving a single dose
Number of subjects experiencing treatment-emergent adverse events
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Time frame: Through Day 35 for subjects receiving multiple doses.
Number of subjects experiencing treatment-emergent adverse events
3 secondary outcomes
Pharmacokinetics (PK) of AT-527
Time frame: Day 1 for subjects receiving a single dose; Days 1 and 7 for subjects receiving multiple doses
Pharmacokinetics (PK) of AT-527
Time frame: Day 1 for subjects receiving a single dose; Days 1 and 7 for subjects receiving multiple doses
Antiviral Activity of AT-527
Time frame: Through Day 6 for subjects receiving a single dose; Through Day 35 for subjects receiving multiple doses.
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 18 Feb 2020.
- Results publication: PubMed 31570394Berliba E, Bogus M, Vanhoutte F, Berghmans PJ, Good SS, Moussa A, Pietropaolo K, Murphy RL, Zhou XJ, Sommadossi JP. Safety, pharmacokinetics and antiviral activity of AT-527, a novel purine nucleotide prodrug, in HCV-infected subjects with and without cirrhosis. Antimicrob Agents Chemother. 2019 Sep 9;63(12):e01201-19. doi: 10.1128/AAC.01201-19. Epub 2019 Sep 30.
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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, PhD study director
Atea Pharmaceuticals, Inc.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AT-527 in people with Chronic Hepatitis C and Hepatitis C, run by Atea Pharmaceuticals, Inc. at 2 sites in 2 countries.
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 9 inclusion and 6 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 18 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Belgium, Moldova. 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 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?
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] (time frame: Through Day 6 for subjects receiving a single dose). 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?
On the ClinicalTrials.gov record for NCT03219957, which also lists 1 linked publication.
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 18 Feb 2020.