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Trial record 35 of 3152 for:    "Hepatitis, Viral, Human"

Study of AT-527 in Healthy and HCV-Infected Subjects

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ClinicalTrials.gov Identifier: NCT03219957
Recruitment Status : Active, not recruiting
First Posted : July 18, 2017
Last Update Posted : June 1, 2018
Sponsor:
Information provided by (Responsible Party):
Atea Pharmaceuticals, Inc.

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.

Condition or disease Intervention/treatment Phase
Chronic Hepatitis C Hepatitis C Hepatitis C, Chronic Drug: AT-527 Other: Placebo Comparator Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 88 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Phase I Study Assessing Single and Multiple Doses of AT-527 in Healthy and HCV-Infected Subjects
Actual Study Start Date : July 6, 2017
Estimated Primary Completion Date : July 2018
Estimated Study Completion Date : August 2018

Arm Intervention/treatment
Experimental: AT-527 Drug: AT-527
Ascending doses of AT-527 administered orally.

Placebo Comparator: Placebo Other: Placebo Comparator
Matching placebo




Primary Outcome Measures :
  1. 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

  2. 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


Secondary Outcome Measures :
  1. Pharmacokinetics (PK) of AT-527 [ Time Frame: Day 1 for subjects receiving a single dose; Days 1 and 7 for subjects receiving multiple doses ]
    Maximum plasma concentration (Cmax)

  2. Pharmacokinetics (PK) of AT-527 [ Time Frame: Day 1 for subjects receiving a single dose; Days 1 and 7 for subjects receiving multiple doses ]
    Area under the concentration-time curve (AUC)

  3. Antiviral Activity of AT-527 [ Time Frame: Through Day 6 for subjects receiving a single dose; Through Day 35 for subjects receiving multiple doses. ]
    Change from baseline in plasma HCV RNA



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03219957


Locations
Belgium
Clinical Trial Site
Antwerp, Belgium
Moldova, Republic of
Clinical Trial Site
Chisinau, Moldova, Republic of
Sponsors and Collaborators
Atea Pharmaceuticals, Inc.
Investigators
Study Director: Xiao-Jian Zhou, PhD Atea Pharmaceuticals, Inc.

Responsible Party: Atea Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT03219957     History of Changes
Other Study ID Numbers: AT-01B-001
First Posted: July 18, 2017    Key Record Dates
Last Update Posted: June 1, 2018
Last Verified: May 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Atea Pharmaceuticals, Inc.:
HCV
Hepatitis C Virus
RNA Viruses
Flavivirus
Liver Diseases
Hepatitis, Viral, Human
Flaviviridae Infections

Additional relevant MeSH terms:
Hepatitis, Viral, Human
Hepatitis
Hepatitis A
Hepatitis C
Hepatitis, Chronic
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections