Study of ANA773 in Healthy Volunteers and Patients With Hepatitis C Virus (HCV) to Assess Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD)

A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Ascending Single and Multiple Dose Study in Healthy Volunteers and Patients With Chronic Hepatitis C Viral Infection to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ANA773 Tosylate

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01211626

Enrollment

Registered

2010-09-29

Start date

2008-06-30

Completion date

2009-08-31

Last updated

2012-11-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HCV Infection

Brief summary

The overall study design includes two parts, Part A and Part B. Part A evaluated ANA773 following oral administration to healthy volunteers. A total of 40 evaluable healthy volunteers were enrolled in Part A of the study. Part B evaluated ANA773 following oral administration to patients with chronic HCV infection. A total of 34 evaluable patients were enrolled in Part B of this study in 2 study centers.

Detailed description

Study Design: Part A evaluated ANA773 following oral administration to healthy volunteers. A total of 40 evaluable healthy volunteers were enrolled in Part A of the study. Part B evaluated ANA773 following oral administration to patients with chronic HCV infection. A total of 34 evaluable patients were enrolled in Part B of this study in 2 study centers.

Interventions

DRUGANA773

ANA773 Tosylate Capsule

DRUGPlacebo

Matching Placebo Capsule

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Yes

Inclusion criteria

Part A Inclusion: * Male or female, ages 18 to 65 years * No clinically significant abnormalities * No serious or severe chronic conditions * Non-smokers Part A Exclusion: * Female subjects who are pregnant or breast-feeding * History of significant medical condition that could interfere with study medication or associated study assessments * History of or current drug or alcohol abuse Part B Inclusion Criteria: * Male or female, ages 18 to 65 years * Diagnosed with chronic liver disease consistent with chronic hepatitis C infection for at least 6 months * Screening HCV RNA ≥ 375,000 copies/mL or ≥ 75,000 IU/mL * Naïve to or have relapsed from prior IFN-alpha based therapy Part B

Exclusion criteria

* Female subjects who are pregnant or breast-feeding * Received anti-viral therapy or immunomodulatory therapy within 90 days prior to administration of the first dose of study medication * Use of an investigational drug or participation in an investigational study with a licensed drug within 30 days * History of significant medical condition that could interfere with study medication or associated study assessments * History of or current drug or alcohol abuse

Design outcomes

Primary

Measure	Time frame	Description
Safety and Pharmacokinetic Analysis in both Healthy Subjects and Chronic HCV Patients	Up to 41 Days	Evaluate the Safety and Pharmacokinetic Analysis in both Healthy Subjects and Chronic HCV Patients

Secondary

Measure	Time frame	Description
Immunological effects in both Healthy Subjects and Chronic HCV Patients	Up to 41 days	Evaluate the immunological effects and antiviral activity as assessed by changes in HCV RNA levels.

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026