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A Study in Healthy Volunteers and Patients With Chronic Hepatitis B

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2016 by Assembly Biosciences
Sponsor:
Information provided by (Responsible Party):
Assembly Biosciences
ClinicalTrials.gov Identifier:
NCT02908191
First received: September 14, 2016
Last updated: March 14, 2017
Last verified: November 2016
  Purpose
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.

Condition Intervention Phase
Chronic Hepatitis B
Drug: ABI-H0731
Drug: Placebo for ABI-H0731
Drug: Entecavir
Drug: Tenofovir disoproxil fumarate
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Investigator
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Assembly Biosciences:

Primary Outcome Measures:
  • Number of healthy volunteers and patients with chronic HBV infection with treatment-related adverse events as assessed by CTCAE v4.0. [ Time Frame: Up to 57 days ]

Estimated Enrollment: 114
Study Start Date: November 2016
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: August 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ABI-H0731
ABI-H0731 in varying doses of tablets by mouth for 1 day, 7 days, or 28 days
Drug: ABI-H0731
Placebo Comparator: Placebo for ABI-H0731
Placebo for ABI-H0731 in varying doses of tablets by mouth for 1 day, 7 days, or 28 days
Drug: Placebo for ABI-H0731
Other Name: Sugar pill manufactured to mimic the ABI-H0731 tablet
Experimental: ABI-H0731 and Entecavir or Tenofovir Disoproxil Fumarate
ABI-H0731 and entecavir or tenofovir in combination in a yet to be determined dose by mouth for 28 days
Drug: ABI-H0731 Drug: Entecavir Drug: Tenofovir disoproxil fumarate

  Eligibility

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

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
  2. Must have chronic hepatitis B with no history of clinical decompensation
  3. Must not have been treated for hepatitis B before
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02908191

Contacts
Contact: Assembly Biosiences clinicaltrials@assemblybio.com

Locations
New Zealand
Recruiting
Auckland, New Zealand
Sponsors and Collaborators
Assembly Biosciences
  More Information

Responsible Party: Assembly Biosciences
ClinicalTrials.gov Identifier: NCT02908191     History of Changes
Other Study ID Numbers: ABI-H0731-101
Study First Received: September 14, 2016
Last Updated: March 14, 2017
Individual Participant Data  
Plan to Share IPD: Undecided

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

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis, Chronic
Hepatitis B
Hepatitis B, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Tenofovir
Entecavir
Antiviral Agents
Anti-Infective Agents
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Anti-HIV Agents

ClinicalTrials.gov processed this record on May 22, 2017