A Phase 2A Randomized, Double-blinded, Placebo-controlled, Multicenter, Dose Ranging Study of Safety and Efficacy of ATI-2173 in Combination With Tenofovir Disoproxil Fumarate in Subjects With Chronic Hepatitis B Virus Infection and in Subjects With Hepatitis D Virus Coinfection

Antios Therapeutics, Inc2 sites in 2 countries40 target enrollmentMarch 30, 2021

ConditionsHepatitis B, Chronic Hepatitis D

InterventionsATI-2173 Viread AB-729

Overview

Phase: Phase 2
Intervention: ATI-2173
Conditions: Hepatitis B, Chronic
Sponsor: Antios Therapeutics, Inc
Enrollment: 40
Locations: 2
Primary Endpoint: The percentage of subjects who experienced at least 1 treatment-emergent adverse event (TEAE)
Status: Terminated
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This is a randomized, double-blinded, placebo-controlled, multi center, dose ranging study of safety and efficacy in both volunteers with chronic hepatitis B virus infection and in volunteers with hepatitis D virus coinfection. Volunteers will be administered multiple oral doses of ATI-2173 and assessed for safety and efficacy including blood tests to show how the body metabolizes and eliminates the investigational drug as well as how the drug effects the virus infection.

Registry

clinicaltrials.gov

Start Date

March 30, 2021

End Date

September 1, 2022

Last Updated

3 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Antios Therapeutics, Inc

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•ALL SUBJECTS:
•Provision of signed and dated informed consent form (ICF)
•Stated willingness to comply with all study procedures and availability for the duration of the study
•If female, meets one of the following criteria:
•Is of childbearing potential and agrees to use an acceptable contraceptive method. Acceptable contraceptive methods include:
•Abstinence from heterosexual intercourse from the first study drug administration through to at least 6 months after the last dose of the study drug or until completion of the study, whichever is longer
•Use a systemic contraceptive or an intrauterine device (with or without hormones), from at least 28 days prior to the first study drug administration through to at least 6 months after the last dose of the study drug or until completion of the study, whichever is longer, with a male condom or a diaphragm/cervical cap plus spermicide from the first study drug administration through to at least 30 days after the last dose of the study drug or until completion of the study, whichever is longer
•Male partner vasectomized at least 6 months prior to the first study drug administration OR
•Male partner has had a vasectomy less than 6 months prior to dosing, and the female subject agrees to use an additional acceptable contraceptive method from the first study drug administration through to at least 6 months after the last dose of the study drug or until completion of the study, whichever is longer Or
•Is of non-childbearing potential, defined as surgically sterile (ie, has undergone complete hysterectomy, bilateral oophorectomy, or tubal ligation) or is in a postmenopausal state (ie, at least 1 year without menses without an alternative medical condition prior to the first study drug administration and follicle-stimulating hormone \[FSH\] levels within the normal ranges for postmenopausal state of the clinical site at screening)

Exclusion Criteria

•Female who is lactating at screening
•Female who is pregnant according to the pregnancy test at screening or prior to the first study drug administration
•History of significant hypersensitivity to clevudine, tenofovir disoproxil fumarate or any related products (including excipients of ATI-2173, tenofovir disoproxil fumarate, and the placebo) as well as severe hypersensitivity reactions (like angioedema) to any drugs
•History of significant cardiovascular, pulmonary, hematologic, neurological, psychiatric, endocrine, immunologic or dermatologic disease
•Presence of clinically significant muscle disorders, myopathies or other forms of liver disease
•Presence of any clinically significant disease, as captured in the medical history or evidence of findings on the physical examination, vital sign assessment and/or ECG assessment, and that would otherwise exclude subject from eligibility in the context of all other listed inclusion and exclusion criteria, as determined by an Investigator
•Presence of clinically significant ECG abnormalities at the screening visit, as defined by medical judgment
•Positive test result for alcohol and/or drugs of abuse at screening or prior to the first drug administration
•Any history of tuberculosis
•Active illicit drug use including, but not limited to, cocaine, heroin and methamphetamine (the use of cannabinoids is acceptable)

Arms & Interventions

ATI-2173 and Viread

ATI-2173 + Tenofovir disoproxil fumarate (Viread)

Intervention: ATI-2173

Placebo and Viread

ATI-2173 Placebo + Tenofovir disoproxil fumarate

Intervention: Viread

ATI-2173, Viread and AB-729

ATI-2173 + Tenofovir disoproxil fumarate (Viread) + AB-729

Intervention: AB-729

Placebo, Viread and AB-729 Placebo

ATI-2173 Placebo + Tenofovir disoproxil fumarate (Viread) + AB-729 Placebo

Intervention: Viread