A Study in Healthy Volunteers and Patients With Chronic Hepatitis B

Chronic Hepatitis B Clinical Trial

Official title:

A Phase 1a/1b, Dose-Ranging Study of the Safety, Tolerability, Pharmacokinetics, and Initial Efficacy of ABI-H0731 in Healthy Volunteers and Patients With Chronic Hepatitis B

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02908191
• Other study ID #: ABI-H0731-101
• Status: Completed
• Phase: Phase 1
• Start date: November 2016
• Est. completion date: June 12, 2018

Study information

• Verified date: April 2019
• Source: Assembly Biosciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This two-part, Phase 1 protocol will be the first clinical study of ABI-H0731. Part I will be a Phase 1a dose-ranging assessment of ABI-H0731 in healthy adult volunteers. If the dose-related safety, tolerability and pharmacokinetics (PK) of ABI-H0731 in human volunteers are deemed satisfactory, then the study will advance to Part II, a Phase 1b dose-ranging assessment of ABI-H0731 in non-cirrhotic, CHB patients.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 86
• Est. completion date: June 12, 2018
• Est. primary completion date: March 31, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Healthy volunteers:

1. Male or female between 18 and 65 years old with a BMI of 18-32kg/m2

2. Must be in good health and not have any health condition which could interfere with the absorption, distribution or elimination of study drug, or with the clinical and laboratory assessments in this study

CHB patients:

1. Male or female between 18 and 65 years of age, with a BMI of 18-35kg/m2 and a minimum body weight of 45 kg

2. Must have chronic hepatitis B with no history of clinical decompensation

3. Seropositive for HIV, HCV, or HDV antibody at Screen

4. Previous treatment with any HBV antiviral treatments within the last 3 months

5. Other known cause of liver disease, including NASH

Related Conditions & MeSH terms

• Chronic Hepatitis B
• Hepatitis
• Hepatitis A
• Hepatitis B
• Hepatitis B, Chronic
• Hepatitis, Chronic

Intervention

Drug:
• ABI-H0731

• Placebo for ABI-H0731

• Entecavir
Used to treat adults with chronic hepatitis B virus
• Tenofovir disoproxil fumarate
Used to treat adults with chronic hepatitis B virus
• Pegasys
Used to treat adults with chronic hepatitis B virus who show signs of liver damage
• Nucleos(t)ide
Used to treat adults with chronic hepatitis B virus

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assembly Biosciences

Country where clinical trial is conducted

New Zealand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of healthy volunteers and patients with chronic HBV infection with treatment-related adverse events as assessed by CTCAE v4.0.		Up to 57 days