Chronic HBV Infection Clinical Trial
Official title:
A Phase 1a/1b Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Doses of EDP 514 in Healthy Subjects (Part 1), and Antiviral Activity in Nucleos(t)Ide Reverse Transcriptase Inhibitor (NUC)-Suppressed Patients With Chronic Hepatitis B Virus Infection (Part 2)
Verified date | May 2021 |
Source | Enanta Pharmaceuticals |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Part 1 is a randomized, double-blind, placebo-controlled study. It will assess the safety, tolerability, and pharmacokinetics of single and multiple orally administered doses of EDP-514 in healthy adult subjects. Part 2 is randomized, double -blind, placebo-controlled study including subjects with Hepatitis B Virus. It will assess the safety, tolerability, pharmacokinetics and antiviral activity of 28 Days of orally administered doses of EDP-514 in nucleos(t)ide reverse transcriptase inhibitor (NUC)-Suppressed Patients with Chronic Hepatitis B Virus Infection
Status | Completed |
Enrollment | 99 |
Est. completion date | July 14, 2021 |
Est. primary completion date | July 14, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility | Part 1 (HV Population): Inclusion Criteria: - An informed consent document signed and dated by the subject. - Healthy male and female subjects of any ethnic origin between the ages of 18 and 65 years, inclusive. Exclusion Criteria: - Clinically relevant evidence or history of illness or disease. - Pregnant or nursing females. - History of febrile illness within 7 days prior to the first dose of study drug or subjects with evidence of active infection. - A positive urine drug screen at screening or Day -1. - Current tobacco smokers or use of tobacco within 3 months prior to screening. - Any condition possibly affecting drug absorption (e.g., gastrectomy, cholecystectomy). - History of regular alcohol consumption. - Receipt of any vaccine, an investigational agent or biological product within 28 days or 5 times the t½, whichever one is longer, prior to first dose. This includes agents administered during clinical trial participation. Part 2 (HBV Population): Inclusion Criteria: - An informed consent document signed and dated by the subject. - Healthy male and female subjects of any ethnic origin between the ages of 18 and 70 years, inclusive - HBV DNA levels: - A Screening HBV DNA level in serum/plasma that is <LLOQ and - No HBV DNA serum/plasma test values =LLOQ over the previous 12 months (using an approved test) - CHB subjects must have been on their prescribed HBV NUC treatment with no change in regimen for 12 months prior to Screening Exclusion Criteria: - A documented prior diagnosis of cirrhosis - Pregnant or nursing females - Coinfection with human immunodeficiency virus (HIV), HCV, HDV, HAV, or HEV - Chronic liver disease of a non-HBV etiology; coexisting liver or biliary diseases |
Country | Name | City | State |
---|---|---|---|
Canada | University Of Calgary | Calgary | Alberta |
Canada | Centre Hospitalier de l'Université de Montréal | Montréal | Quebec |
Canada | Toronto General Hospital | Toronto | Ontario |
Canada | Gastroenterology Institute of Research Institute | Vancouver | British Columbia |
United States | Digestive Disease Associates - Catonsville | Catonsville | Maryland |
United States | Southern California GI and Liver Centers | Coronado | California |
United States | American Research Corporation | Houston | Texas |
United States | Pharmaceutical Research Associates, Inc. | Lenexa | Kansas |
United States | University of California Los Angeles | Los Angeles | California |
United States | University of Miami Miller School of Medicine | Miami | Florida |
United States | Icahn School of Medicine at Mount Sinai | New York | New York |
United States | The Texas Liver Institute | San Antonio | Texas |
United States | Tuan Nguyen Md Gastroenterology & Hepatology (Tuan Nguyen, M.D., Inc.) | San Diego | California |
United States | Quest Clinical Research | San Francisco | California |
United States | Swedish Organ Transplant and Liver Center | Seattle | Washington |
Lead Sponsor | Collaborator |
---|---|
Enanta Pharmaceuticals | Pharmaceutical Research Associates |
United States, Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Safety measured by adverse events | Up to 8 Days in HV SAD Cohorts | ||
Primary | Safety measured by adverse events | Up to 21 Days in HV MAD Cohorts | ||
Primary | Safety measured by adverse events | Up to 56 Days in HBV MAD Cohorts | ||
Secondary | Cmax of EDP-514 | Up to 6 Days in HV SAD Cohorts | ||
Secondary | AUC of EDP-514 | Up to 6 Days in HV SAD Cohorts | ||
Secondary | Cmax of EDP-514 | Up to 18 Days in HV MAD Cohorts | ||
Secondary | AUC of EDP-514 | Up to 18 Days in HV MAD Cohorts | ||
Secondary | Cmax of EDP-514 | Up to 28 Days in HBV MAD Cohorts | ||
Secondary | AUC of EDP-514 | Up to 28 Days in HBV MAD Cohorts |
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