Clinical trial NCT03219957: Study of AT-527 in Healthy and HCV-Infected Subjects
Official title: A Phase I Study Assessing Single and Multiple Doses of AT-527 in Healthy and HCV-Infected Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Chronic Hepatitis C
Hepatitis C
Hepatitis C, Chronic
Keywords: HCV
Hepatitis C Virus
RNA Viruses
Flavivirus
Liver Diseases
Hepatitis, Viral, Human
Flaviviridae Infections
Lead sponsor: Atea Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2017-07-18
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion Criteria:

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:

* 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.

Exclusion Criteria:

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

Primary outcomes:
measure: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
timeFrame: Through Day 6 for subjects receiving a single dose
measure: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
timeFrame: Through Day 35 for subjects receiving multiple doses.
Secondary outcomes:
measure: Pharmacokinetics (PK) of AT-527
timeFrame: Day 1 for subjects receiving a single dose; Days 1 and 7 for subjects receiving multiple doses
measure: Pharmacokinetics (PK) of AT-527
timeFrame: Day 1 for subjects receiving a single dose; Days 1 and 7 for subjects receiving multiple doses
measure: Antiviral Activity of AT-527
timeFrame: Through Day 6 for subjects receiving a single dose; Through Day 35 for subjects receiving multiple doses.
Other outcomes:
Locations:
city: Antwerp
country: Belgium
facility: Clinical Trial Site
city: Chisinau
country: Moldova, Republic of
facility: Clinical Trial Site
Study officials:
affiliation: Atea Pharmaceuticals, Inc.
name: Xiao-Jian Zhou, PhD
role: STUDY_DIRECTOR
References:
citation: 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.